Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
28. června 2018 aktualizováno: GlaxoSmithKline
Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing
Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer.
GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers.
In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia.
In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The protocol posting has been updated following a protocol amendment.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
961
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 2C8
- GSK Investigational Site
-
-
British Columbia
-
Langley, British Columbia, Kanada, V3A 4H9
- GSK Investigational Site
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Kanada, A1E 2C2
- GSK Investigational Site
-
-
Nova Scotia
-
Truro, Nova Scotia, Kanada, B2N 1L2
- GSK Investigational Site
-
-
Quebec
-
Quebec City, Quebec, Kanada, G1E 7G9
- GSK Investigational Site
-
-
-
-
-
Berlin, Německo, 13086
- GSK Investigational Site
-
Berlin, Německo, 13125
- GSK Investigational Site
-
Hamburg, Německo, 20246
- GSK Investigational Site
-
Hamburg, Německo, 22525
- GSK Investigational Site
-
Hamburg, Německo, 22159
- GSK Investigational Site
-
-
Baden-Wuerttemberg
-
Karlsruhe, Baden-Wuerttemberg, Německo, 76199
- GSK Investigational Site
-
Kehl, Baden-Wuerttemberg, Německo, 77694
- GSK Investigational Site
-
Rheinstetten, Baden-Wuerttemberg, Německo, 76287
- GSK Investigational Site
-
Tauberbischofsheim, Baden-Wuerttemberg, Německo, 97941
- GSK Investigational Site
-
-
Bayern
-
Muenchen, Bayern, Německo, 80637
- GSK Investigational Site
-
Weilheim, Bayern, Německo, 82362
- GSK Investigational Site
-
Wuerzburg, Bayern, Německo, 97070
- GSK Investigational Site
-
-
Hessen
-
Frankfurt, Hessen, Německo, 60439
- GSK Investigational Site
-
-
Niedersachsen
-
Hannover, Niedersachsen, Německo, 30625
- GSK Investigational Site
-
Hannover, Niedersachsen, Německo, 30657
- GSK Investigational Site
-
Wolfenbuettel, Niedersachsen, Německo, 38302
- GSK Investigational Site
-
-
Rheinland-Pfalz
-
Trier, Rheinland-Pfalz, Německo, 54290
- GSK Investigational Site
-
-
Sachsen
-
Leipzig, Sachsen, Německo, 04109
- GSK Investigational Site
-
-
Schleswig-Holstein
-
Flensburg, Schleswig-Holstein, Německo, 24937
- GSK Investigational Site
-
-
Thueringen
-
Nordhausen, Thueringen, Německo, 99734
- GSK Investigational Site
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
9 let až 25 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study.
- A female subject between, and including, 9 and 25 years of age at the time of the first vaccination.
- Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject's parents/legally acceptable representative, and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 24).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of 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.
- Pregnant or breastfeeding female.
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24).
- Previous administration of components of the investigational vaccine.
- Cancer or autoimmune disease under treatment.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period (up to Month 24).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Cervarix 1/Placebo Group
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6.
The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Ostatní jména:
Intramuscular injection, different dosing /schedule
|
|
Experimentální: Cervarix 1/Placebo/Cervarix 1 Group
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Ostatní jména:
Intramuscular injection, different dosing /schedule
|
|
Experimentální: Cervarix 2/Placebo/Cervarix 2 Group
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Ostatní jména:
Intramuscular injection, different dosing /schedule
|
|
Experimentální: Cervarix 2 Group
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6.
The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
|
Intramuscular injection, different dosing /schedule
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Časové okno: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
|
|
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms
Časové okno: Within 7 days (Day 0-6) after vaccination.
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the solicited local symptom irrespective of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).
|
Within 7 days (Day 0-6) after vaccination.
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Časové okno: Within 7 days (Day 0-6) after vaccination.
|
Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria.
Grade 3 symptoms = symptoms that prevented normal activity.
Grade 3 fever = axillary temperature ≥ 39 °C.
Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Related symptom = symptom assessed by the investigator to be causally related to vaccination.
|
Within 7 days (Day 0-6) after vaccination.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .
Časové okno: At Month 3, 1 month after the second dose of vaccine or placebo
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.
|
At Month 3, 1 month after the second dose of vaccine or placebo
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Časové okno: At Month 7, 1 month after the last dose of vaccine or placebo.
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination.
The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.
|
At Month 7, 1 month after the last dose of vaccine or placebo.
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Časové okno: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Časové okno: At Month 7, 1 month after the last dose of vaccine or placebo.
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
At Month 7, 1 month after the last dose of vaccine or placebo.
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents BAS results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents EOS results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents Hct results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents ALT results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents LYM results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents MON results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents NEU results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents RBC results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents WBC results.
|
At Month 7 (M7)
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Časové okno: At Month 7 (M7)
|
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC).
Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range.
Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.
This outcome presents PLA results.
|
At Month 7 (M7)
|
|
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Časové okno: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination.
Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18.
Seronegative subjects are subjects who had an antibody concentration below cut-off value.
Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.
|
At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
|
|
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Časové okno: At Month 60 of the safety follow-up phase
|
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
|
At Month 60 of the safety follow-up phase
|
|
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Časové okno: At Month 60 of the safety follow-up phase
|
Seroconversion was defined as the appearance of antibodies (i.e.
titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination.
Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
Seronegative subjects are subjects who had an antibody concentration below cut-off value.
|
At Month 60 of the safety follow-up phase
|
|
Number of Subjects With Pregnancy Outcomes.
Časové okno: From Month 0 to Month 48.
|
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
|
From Month 0 to Month 48.
|
|
Number of Subjects With Pregnancy Outcomes.
Časové okno: Throughout the study period, from Month 0 to Month 60.
|
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Časové okno: Within 30 days (Day 0-29) after vaccination.
|
An unsolicited adverse event (AE) 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 = an event that prevented normal activity.
Related = an event assessed by the investigator as causally related to the study vaccination.
|
Within 30 days (Day 0-29) after vaccination.
|
|
Number of Subjects With Medically Significant Conditions (MSCs).
Časové okno: From Month 0 to Month 7.
|
MSCs 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.
The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
|
From Month 0 to Month 7.
|
|
Number of Subjects With Medically Significant Conditions (MSCs).
Časové okno: From Month 0 to Month 48.
|
MSCs 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.
The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
|
From Month 0 to Month 48.
|
|
Number of Subjects With Medically Significant Conditions (MSCs).
Časové okno: Throughout the study period, from Month 0 to Month 60.
|
MSCs 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.
The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
Časové okno: From Month 0 to Month 7.
|
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 7.
|
|
Number of Subjects With New Onset of Autoimune Diseases (NOADs)
Časové okno: From Month 0 to Month 48.
|
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 48.
|
|
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
Časové okno: Throughout the study period, from Month 0 to Month 60.
|
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Časové okno: From Month 0 to Month 7.
|
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 7.
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Časové okno: From Month 0 to Month 48.
|
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
From Month 0 to Month 48.
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Časové okno: Throughout the study period, from Month 0 to Month 60.
|
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
|
Throughout the study period, from Month 0 to Month 60.
|
|
Number of Subjects With Serious Adverse Events (SAEs).
Časové okno: From Month 0 to Month 7.
|
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.
|
From Month 0 to Month 7.
|
|
Number of Subjects With Serious Adverse Events (SAEs).
Časové okno: From Month 0 to Month 48.
|
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
From Month 0 to Month 48.
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Časové okno: Throughout the study period, from Month 0 to Month 60.
|
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
Throughout the study period, from Month 0 to Month 60.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Catteau G, Dobbelaere K, Schuind A, Descamps D. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin. 2011 Dec;7(12):1374-86. doi: 10.4161/hv.7.12.18322. Epub 2011 Dec 1.
- Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.
- Folschweiller N, Behre U, Dionne M, Durando P, Esposito S, Ferguson L, Ferguson M, Hillemanns P, McNeil SA, Peters K, Ramjattan B, Schwarz TF, Supparatpinyo K, Suryakirian PV, Janssens M, Moris P, Decreux A, Poncelet S, Struyf F. Long-term Cross-reactivity Against Nonvaccine Human Papillomavirus Types 31 and 45 After 2- or 3-Dose Schedules of the AS04-Adjuvanted Human HPV-16/18 Vaccine. J Infect Dis. 2019 May 5;219(11):1799-1803. doi: 10.1093/infdis/jiy743.
- Romanowski B, Schwarz TF, Ferguson L, Peters K, Dionne M, Behre U, Schulze K, Hillemanns P, Suryakiran P, Thomas F, Struyf F. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study. Hum Vaccin Immunother. 2016;12(1):20-9. doi: 10.1080/21645515.2015.1065363. Epub 2015 Jul 15.
- Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Behre U, Suryakiran P, Thomas F, Struyf F. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study. Hum Vaccin Immunother. 2014;10(5):1155-65. doi: 10.4161/hv.28022. Epub 2014 Feb 27.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
17. října 2007
Primární dokončení (Aktuální)
18. března 2013
Dokončení studie (Aktuální)
18. března 2013
Termíny zápisu do studia
První předloženo
9. října 2007
První předloženo, které splnilo kritéria kontroly kvality
9. října 2007
První zveřejněno (Odhad)
10. října 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. srpna 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. června 2018
Naposledy ověřeno
1. srpna 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 110659
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studijní data/dokumenty
-
Plán statistické analýzy
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář komentované zprávy o případu
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Soubor dat jednotlivých účastníků
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Protokol studie
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifikace datové sady
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář informovaného souhlasu
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Zpráva o klinické studii
Identifikátor informace: 110659Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .