- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00337428
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
27 września 2016 zaktualizowane przez: Merck Sharp & Dohme LLC
An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX™ in Healthy Adolescents 11-17 Years of Age
Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
- Biologiczny: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
- Biologiczny: Comparator: REPEVAX™ (Concomitant)
- Biologiczny: Comparator: REPEVAX™ (Non-Concomitant)
- Biologiczny: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
843
Faza
- Faza 3
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
11 lat do 17 lat (Dziecko)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Must be healthy boys or girls, 11-17 years of age
- Must be a virgin with no intention of becoming sexually active during the study period
- Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio
Exclusion Criteria:
- Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years
- Must not have received any prior human papillomavirus (HPV) vaccine
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Group 1
Concomitant/CMF
|
GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
|
Eksperymentalny: Group 2
Non-Concomitant/CMF
|
GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
|
Eksperymentalny: Group 3
Concomitant/FMF
|
REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
|
Eksperymentalny: Group 4
Non-Concomitant/FMF
|
REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay.
Titers were reported in milli Merck Units (mMU)/milliliter (mL).
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay.
Titers were reported in milli Merck Units (mMU)/milliliter (mL).
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay.
Titers were reported in milli Merck Units (mMU)/milliliter (mL).
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay.
Titers were reported in milli Merck Units (mMU)/milliliter (mL).
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT.
The cutoff value for HPV seropositivity was ≥20 mMU/mL.
Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT.
The cutoff value for HPV seropositivity was ≥16 mMU/mL.
Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT.
The cutoff value for HPV seropositivity was ≥20 mMU/mL.
Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)
Ramy czasowe: Up to 7 Months (4 Weeks Postdose 3)
|
Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT.
The cutoff value for HPV seropositivity was ≥24 mMU/mL.
Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 7 Months (4 Weeks Postdose 3)
|
Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin.
An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL).
Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 1 Month (1 Month Postdose 1)
|
Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin.
An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL).
Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 1 Month (1 Month Postdose 1)
|
Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3).
An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera.
The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 1 Month (1 Month Postdose 1)
|
Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3).
An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera.
The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 1 Month (1 Month Postdose 1)
|
Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3).
An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera.
The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
|
Up to 1 Month (1 Month Postdose 1)
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA).
Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL.
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 1 Month (1 Month Postdose 1)
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA.
Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL.
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 1 Month (1 Month Postdose 1)
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA.
Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL.
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 1 Month (1 Month Postdose 1)
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™
Ramy czasowe: Up to 1 Month (1 Month Postdose 1)
|
Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA.
Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL.
GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant).
An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
|
Up to 1 Month (1 Month Postdose 1)
|
Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 maja 2006
Zakończenie podstawowe (Rzeczywisty)
1 maja 2007
Ukończenie studiów (Rzeczywisty)
1 maja 2007
Daty rejestracji na studia
Pierwszy przesłany
14 czerwca 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
15 czerwca 2006
Pierwszy wysłany (Oszacować)
16 czerwca 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
16 listopada 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 września 2016
Ostatnia weryfikacja
1 września 2016
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje dróg oddechowych
- Choroby Układu Oddechowego
- Nowotwory według typu histologicznego
- Nowotwory
- Choroby nerwowo-mięśniowe
- Infekcje ośrodkowego układu nerwowego
- Infekcje Bordetelli
- Zakażenia bakteriami Gram-ujemnymi
- Infekcje bakteryjne
- Infekcje bakteryjne i grzybice
- Zakażenia bakteriami Gram-dodatnimi
- Infekcje Actinomycetales
- Infekcje enterowirusowe
- Infekcje Picornaviridae
- Choroby rdzenia kręgowego
- Infekcje Clostridium
- Zakażenia Corynebacterium
- Zapalenie rdzenia kręgowego
- Krztusiec
- Tężec
- Błonica
- Nowotwory gruczołowe i nabłonkowe
- Paraliż dziecięcy
- Fizjologiczne skutki leków
- Czynniki immunologiczne
- Szczepionki
Inne numery identyfikacyjne badania
- V501-024
- 2005_093
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