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 de septiembre de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
- Biológico: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
- Biológico: Comparator: REPEVAX™ (Concomitant)
- Biológico: Comparator: REPEVAX™ (Non-Concomitant)
- Biológico: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
Tipo de estudio
Intervencionista
Inscripción (Actual)
843
Fase
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
11 años a 17 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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™
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2006
Finalización primaria (Actual)
1 de mayo de 2007
Finalización del estudio (Actual)
1 de mayo de 2007
Fechas de registro del estudio
Enviado por primera vez
14 de junio de 2006
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2006
Publicado por primera vez (Estimar)
16 de junio de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
27 de septiembre de 2016
Última verificación
1 de septiembre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades Neuromusculares
- Infecciones del Sistema Nervioso Central
- Infecciones por Bordetella
- Infecciones por bacterias gramnegativas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias grampositivas
- Infecciones por Actinomycetales
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Enfermedades de la médula espinal
- Infecciones por Clostridium
- Infecciones por Corynebacterium
- Mielitis
- Tos ferina
- Tétanos
- Difteria
- Neoplasias Glandulares y Epiteliales
- Poliomielitis
- Efectos fisiológicos de las drogas
- Factores inmunológicos
- Vacunas
Otros números de identificación del estudio
- V501-024
- 2005_093
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .