A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
12 de julho de 2018 atualizado por: Merck Sharp & Dohme LLC
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age.
From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1518
Estágio
- Fase 3
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
9 anos a 26 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
All Participants:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 Years:
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
Exclusion Criteria:
All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Girls 9 to 14 Years V503 at Months 0 and 6
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Experimental: Boys 9 to 14 Years V503 at Months 0 and 6
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Experimental: Girls and Boys 9 to 14 Years V503 at Months 0 and 12
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Experimental: Girls 9 to 14 Years V503 at Months 0, 2, and 6
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Comparador Ativo: Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Prazo: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Prazo: Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 24
|
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Prazo: Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 24
|
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Prazo: Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 36
|
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Prazo: Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 36
|
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
- Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615.
- Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22.
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)
12 de dezembro de 2013
Conclusão Primária (Real)
19 de junho de 2015
Conclusão do estudo (Real)
24 de julho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
8 de novembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de novembro de 2013
Primeira postagem (Estimativa)
15 de novembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de agosto de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de julho de 2018
Última verificação
1 de julho de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- V503-010 (Outro identificador: Merck Protocol Number)
- 2013-001314-15 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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 .
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