Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older
27 de dezembro de 2019 atualizado por: GlaxoSmithKline
A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above
This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control.
Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits.
Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
The Protocol Posting has been updated due to protocol amendment 5 and in order to comply with the FDA Amendment Act, Sep 2007.
Tipo de estudo
Intervencional
Inscrição (Real)
5752
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Victoria
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Parkville, Victoria, Austrália, 3052
- GSK Investigational Site
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Western Australia
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Perth, Western Australia, Austrália
- GSK Investigational Site
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Quebec, Canadá, G1S 2L6
- GSK Investigational Site
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Alberta
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Edmonton, Alberta, Canadá, T6G 2C8
- GSK Investigational Site
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3N1
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 2Y9
- GSK Investigational Site
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Truro, Nova Scotia, Canadá, B2N 1L2
- GSK Investigational Site
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Ontario
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Waterloo, Ontario, Canadá, N2L 6H6
- GSK Investigational Site
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Quebec
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Sherbrooke, Quebec, Canadá, J1H 1Z1
- GSK Investigational Site
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Singapore, Cingapura, 119074
- GSK Investigational Site
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Singapore, Cingapura, 229899
- GSK Investigational Site
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California
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Fountain Valley, California, Estados Unidos, 92708
- GSK Investigational Site
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- GSK Investigational Site
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Golden, Colorado, Estados Unidos, 80401
- GSK Investigational Site
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Florida
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Coral Gables, Florida, Estados Unidos, 33134
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33136
- GSK Investigational Site
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Georgia
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Augusta, Georgia, Estados Unidos, 30912
- GSK Investigational Site
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- GSK Investigational Site
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Kansas
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Wichita, Kansas, Estados Unidos, 67207
- GSK Investigational Site
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- GSK Investigational Site
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Louisville, Kentucky, Estados Unidos, 40202
- GSK Investigational Site
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Minnesota
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Chaska, Minnesota, Estados Unidos, 55318
- GSK Investigational Site
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
- GSK Investigational Site
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- GSK Investigational Site
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- GSK Investigational Site
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New York
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Syracuse, New York, Estados Unidos, 13057
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- GSK Investigational Site
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New Bern, North Carolina, Estados Unidos, 28562
- GSK Investigational Site
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Ohio
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Akron, Ohio, Estados Unidos, 44311
- GSK Investigational Site
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Cleveland, Ohio, Estados Unidos, 44122
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74105
- GSK Investigational Site
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- GSK Investigational Site
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Pennsylvania
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Carnegie, Pennsylvania, Estados Unidos, 15106
- GSK Investigational Site
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Erie, Pennsylvania, Estados Unidos, 16508
- GSK Investigational Site
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Erie, Pennsylvania, Estados Unidos, 16507
- GSK Investigational Site
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- GSK Investigational Site
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Pittsburgh, Pennsylvania, Estados Unidos, 15236
- GSK Investigational Site
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- GSK Investigational Site
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Wexford, Pennsylvania, Estados Unidos, 15090
- GSK Investigational Site
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Texas
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Austin, Texas, Estados Unidos, 78705
- GSK Investigational Site
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Houston, Texas, Estados Unidos, 77030
- GSK Investigational Site
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Houston, Texas, Estados Unidos, 77004
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, Estados Unidos, 84109
- GSK Investigational Site
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Salt Lake City, Utah, Estados Unidos, 84121
- GSK Investigational Site
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South Jordan, Utah, Estados Unidos, 84095
- GSK Investigational Site
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Washington
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Wenatchee, Washington, Estados Unidos, 98801
- GSK Investigational Site
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601
- GSK Investigational Site
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Ekaterinburg, Federação Russa, 620073
- GSK Investigational Site
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Moscow, Federação Russa, 117997
- GSK Investigational Site
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Moscow, Federação Russa, 115 478
- GSK Investigational Site
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Moscow, Federação Russa, 109263
- GSK Investigational Site
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Sankt-Petersburg, Federação Russa, 190020
- GSK Investigational Site
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Sankt-Petersburg, Federação Russa, 199034
- GSK Investigational Site
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Laguna, Filipinas
- GSK Investigational Site
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San Pablo City, Filipinas
- GSK Investigational Site
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Taft Avenue, Manila, Filipinas, 1700
- GSK Investigational Site
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Amsterdam, Holanda, 1007 MB
- GSK Investigational Site
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Delft, Holanda, 2625 AD
- GSK Investigational Site
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Rotterdam, Holanda, 3015 CE
- GSK Investigational Site
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Jojutla / Morelos, México
- GSK Investigational Site
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Morelos
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Cuenavaca, Morelos, México, 62430
- GSK Investigational Site
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Lima, Peru
- GSK Investigational Site
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Almada, Portugal, 2805-267 Almada
- GSK Investigational Site
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Coimbra, Portugal, 3000-075 Coimbra
- GSK Investigational Site
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Lisboa, Portugal, 1200-831 Lisboa
- GSK Investigational Site
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Porto, Portugal, 4200-023 Porto
- GSK Investigational Site
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Setúbal, Portugal, 2910-446 Setúbal
- GSK Investigational Site
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Aberdeen, Reino Unido, AB25 7ZD
- GSK Investigational Site
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Cardiff, Reino Unido, CF14 4XN
- GSK Investigational Site
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Gateshead, Reino Unido, NE9 6SX
- GSK Investigational Site
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London, Reino Unido, EC1M 6BQ
- GSK Investigational Site
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Manchester, Reino Unido, M13 9WL
- GSK Investigational Site
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Middlesex
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Northwood, Middlesex, Reino Unido, HA6 2RN
- GSK Investigational Site
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Bangkok, Tailândia, 10400
- GSK Investigational Site
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Bangkok, Tailândia, 10700
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
26 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion criteria:
- A woman who the investigator believes that she can and will comply with the requirements of the protocol.
- A women of at least 26 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subject must have intact cervix.
- Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential.
- Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion criteria:
- Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).
- A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 - 29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- Previous administration of components of the investigational vaccine
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- History of chronic condition(s) requiring treatment.
- Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine, or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
- Acute disease at the time of enrolment.
- Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Cervarix Group
Subjects received 3 doses of Cervarix™ vaccine.
Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
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Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
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Comparador de Placebo: Aluminium Hydroxide Group
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3].
Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
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Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
Prazo: Up to Month 48
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CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
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Up to Month 48
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Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Prazo: Up to Month 48
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CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
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Up to Month 48
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Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
Prazo: Up to Month 84
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CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
- DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
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Up to Month 84
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Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Prazo: Up to Month 84
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CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer.
Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
- DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
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Up to Month 84
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Prazo: Up to Month 48
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Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in:
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Up to Month 48
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Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Prazo: Up to Month 48
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Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).
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Up to Month 48
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Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Prazo: Up to Month 48
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Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
Up to Month 48
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Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Prazo: Up to Month 48
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Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68 |
Up to Month 48
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Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Prazo: Up to Month 48
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CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in:
Note: Results for seropositive status were not analysed. |
Up to Month 48
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Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Prazo: Up to Month 48
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CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in:
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Up to Month 48
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Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Prazo: Up to Month 48
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CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. |
Up to Month 48
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Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
Prazo: Up to Month 48
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CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status. |
Up to Month 48
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Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Prazo: Up to Month 48
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Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in:
Results for seropositive status were not analysed. |
Up to Month 48
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Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Prazo: Up to Month 48
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Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 |
Up to Month 48
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Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Prazo: Up to Month 48
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Detection was done on all subjects irrespective of their baseline HPV DNA status.
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Up to Month 48
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Number of Subjects With First Colposcopy
Prazo: Up to Month 48
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Detection was done on all subjects irrespective of their baseline HPV DNA status.
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Up to Month 48
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Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Prazo: Up to Month 48
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Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. |
Up to Month 48
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Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Prazo: Up to Month 48
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Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types) |
Up to Month 48
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Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Prazo: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region |
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Prazo: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region |
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Prazo: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) |
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Prazo: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) |
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
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Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
Prazo: Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
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Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50).
Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination.
Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination.
ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%
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Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
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Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
Prazo: Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
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Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50% |
Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Prazo: Within 7 days (Days 0-6) after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as any solicited local symptom reported irrespective of intensity.
Grade 3 pain was defined as pain that prevented normal activity.
Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
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Within 7 days (Days 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Prazo: Within 7 days (Days 0-6) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)).
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Grade 3 symptoms = symptoms that prevented normal activity.
Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Grade 3 fever = axillary temperature above 39.0°C.
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Within 7 days (Days 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Prazo: Within 30 days (Days 0 - 29) post-vaccination period.
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An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination. |
Within 30 days (Days 0 - 29) post-vaccination period.
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Prazo: Up to Month 48 and up to Month 84
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SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.
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Up to Month 48 and up to Month 84
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Number of Subjects Reporting Related or Fatal Serious Adverse Event.
Prazo: Up to Month 84
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Up to Month 84
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Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.
Prazo: Up to Month 84
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Up to Month 84
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Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).
Prazo: Up to Month 48
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NOCDs include autoimmune disorders, asthma and type I diabetes.
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Up to Month 48
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Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).
Prazo: Up to Month 48
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Up to Month 48
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|
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Number of Subjects Reporting Medically Significant Conditions (MAEs).
Prazo: Up to Month 48
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Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
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Up to Month 48
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Number of Subjects With Pregnancies and Their Outcomes.
Prazo: Up to Month 48
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Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing.
For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
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Up to Month 48
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Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
Prazo: Up to Month 48
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CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if
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Up to Month 48
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Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Prazo: Up to Month 84
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Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
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Up to Month 84
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Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Prazo: Up to Month 84
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Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).
- DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
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Up to Month 84
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Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Prazo: Up to Month 84
|
Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.
HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18.
HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
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Up to Month 84
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Prazo: Up to Month 84
|
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus.
HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68
|
Up to Month 84
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Prazo: Up to Month 84
|
CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Note: Results for seropositive status were not analysed.
|
Up to Month 84
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Prazo: Up to Month 84
|
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
|
Up to Month 84
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Prazo: Up to Month 84
|
Up to Month 84
|
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
Prazo: Up to Month 84
|
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
|
Up to Month 84
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Prazo: Up to Month 84
|
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Results for seropositive status were not analysed.
|
Up to Month 84
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Prazo: Up to Month 48
|
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.
HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
|
Up to Month 48
|
|
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Prazo: Up to Month 84
|
Detection was done on all subjects irrespective of their baseline HPV DNA status.
|
Up to Month 84
|
|
Number of Subjects With First Colposcopy
Prazo: Up to Month 84
|
Detection was done on all subjects irrespective of their baseline HPV DNA status.
|
Up to Month 84
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Prazo: Up to Month 84
|
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
|
Up to Month 84
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Prazo: Up to Month 84
|
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)
|
Up to Month 84
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
- Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec. Erratum In: Open Forum Infect Dis. 2020 Feb 28;7(3):ofaa036.
- Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.
- Skinner SR, Szarewski A, Romanowski B, Garland SM, Lazcano-Ponce E, Salmeron J, Del Rosario-Raymundo MR, Verheijen RH, Quek SC, da Silva DP, Kitchener H, Fong KL, Bouchard C, Money DM, Ilancheran A, Cruickshank ME, Levin MJ, Chatterjee A, Stapleton JT, Martens M, Quint W, David MP, Meric D, Hardt K, Descamps D, Geeraerts B, Struyf F, Dubin G; VIVIANE Study Group. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet. 2014 Dec 20;384(9961):2213-27. doi: 10.1016/S0140-6736(14)60920-X. Epub 2014 Sep 1.
- Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, Garland SM, Chatterjee A, Lazcano-Ponce E, Salmeron J, McNeil S, Stapleton JT, Bouchard C, Martens MG, Money DM, Quek SC, Romanowski B, Vallejos CS, Ter Harmsel B, Prilepskaya V, Fong KL, Kitchener H, Minkina G, Lim YKT, Stoney T, Chakhtoura N, Cruickshank ME, Savicheva A, da Silva DP, Ferguson M, Molijn AC, Quint WGV, Hardt K, Descamps D, Suryakiran PV, Karkada N, Geeraerts B, Dubin G, Struyf F; VIVIANE Study Group. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet Infect Dis. 2016 Oct;16(10):1154-1168. doi: 10.1016/S1473-3099(16)30120-7. Epub 2016 Jun 28.
- Wheeler CM, Struyf F; HPV-015 study group. The safety of Cervarix? - Authors' reply. Lancet Infect Dis. 2017 Jan;17(1):20-21. doi: 10.1016/S1473-3099(16)30540-0. No abstract available.
- Rosillon D, Baril L, Del Rosario-Raymundo MR, Wheeler CM, Skinner SR, Garland SM, Salmeron J, Lazcano-Ponce E, Vallejos CS, Stoney T, Ter Harmsel B, Lim TYK, Quek SC, Minkina G, McNeil SA, Bouchard C, Fong KL, Money D, Ilancheran A, Savicheva A, Cruickshank M, Chatterjee A, Fiander A, Martens M, Bozonnat MC, Struyf F, Dubin G, Castellsague X. Risk of newly detected infections and cervical abnormalities in adult women seropositive or seronegative for naturally acquired HPV-16/18 antibodies. Cancer Med. 2019 Aug;8(10):4938-4953. doi: 10.1002/cam4.1879. Epub 2019 Jul 5.
- Skinner SR, Wheeler CM, Romanowski B, Castellsague X, Lazcano-Ponce E, Del Rosario-Raymundo MR, Vallejos C, Minkina G, Pereira Da Silva D, McNeil S, Prilepskaya V, Gogotadze I, Money D, Garland SM, Romanenko V, Harper DM, Levin MJ, Chatterjee A, Geeraerts B, Struyf F, Dubin G, Bozonnat MC, Rosillon D, Baril L; VIVIANE Study Group. Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study. Int J Cancer. 2016 May 15;138(10):2428-38. doi: 10.1002/ijc.29971.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
16 de fevereiro de 2006
Conclusão Primária (Real)
29 de janeiro de 2014
Conclusão do estudo (Real)
29 de janeiro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
17 de fevereiro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de fevereiro de 2006
Primeira postagem (Estimativa)
20 de fevereiro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de dezembro de 2019
Última verificação
1 de dezembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 104820
- 2005-002546-20 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Prazo de Compartilhamento de IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Critérios de acesso de compartilhamento IPD
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Dados/documentos do estudo
-
Formulário de Consentimento Informado
Identificador de informação: 104820Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Relatório de Estudo Clínico
Identificador de informação: 104820Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocolo de estudo
Identificador de informação: 104820Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Especificação do conjunto de dados
Identificador de informação: 104820Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de dados de participantes individuais
Identificador de informação: 104820Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Plano de Análise Estatística
Identificador de informação: 104820Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .