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 settembre 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
- Biologico: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
- Biologico: Comparator: REPEVAX™ (Concomitant)
- Biologico: Comparator: REPEVAX™ (Non-Concomitant)
- Biologico: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
Tipo di studio
Interventistico
Iscrizione (Effettivo)
843
Fase
- Fase 3
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 11 anni a 17 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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™
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2006
Completamento primario (Effettivo)
1 maggio 2007
Completamento dello studio (Effettivo)
1 maggio 2007
Date di iscrizione allo studio
Primo inviato
14 giugno 2006
Primo inviato che soddisfa i criteri di controllo qualità
15 giugno 2006
Primo Inserito (Stima)
16 giugno 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 novembre 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 settembre 2016
Ultimo verificato
1 settembre 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Neoplasie per tipo istologico
- Neoplasie
- Malattie neuromuscolari
- Infezioni del sistema nervoso centrale
- Infezioni da bordetella
- Infezioni batteriche Gram-negative
- Infezioni batteriche
- Infezioni batteriche e micosi
- Infezioni batteriche Gram-positive
- Infezioni da actinomiceti
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Malattie del midollo spinale
- Infezioni da Clostridium
- Infezioni da Corynebacterium
- Mielite
- Pertosse
- Tetano
- Difterite
- Neoplasie, ghiandolari ed epiteliali
- Poliomielite
- Effetti fisiologici delle droghe
- Fattori immunologici
- Vaccini
Altri numeri di identificazione dello studio
- V501-024
- 2005_093
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .