Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Study Overview
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Brief Summary
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Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Official Title
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An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra™ and ADACEL™ in Healthy Adolescents 11-17 Years of Age

Conditions
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Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough, Meningitis

Intervention / Treatment
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* Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
* Biological: Comparator: Menactra™ (Concomitant)
* Biological: Comparator: Adacel™ (Concomitant)
* Biological: Comparator: Menactra™ (Non-concomitant)
* Biological: Comparator: Adacel™


Participation Criteria
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Eligibility Criteria
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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 and pertussis Exclusion Criteria: Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Concomitant Administration | Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine<br>* Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.<br>* Other names: Gardasil;Biological: Comparator: Menactra™ (Concomitant)<br>* A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1<br>Biological: Comparator: Adacel™ (Concomitant)<br>* a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1<br>|
| Experimental: Group 2<br>Non-concomitant administration | Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine<br>* Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.<br>* Other names: Gardasil;Biological: Comparator: Menactra™ (Non-concomitant)<br>* A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1<br>Biological: Comparator: Adacel™<br>* A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) |  | 7 Months | 
| Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months) |  | 7 Months | 
| Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) |  | 7 Months | 
| Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months) |  | 7 Months | 
| Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™ |  | 7 Months | 
| Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™ |  | 7 Months | 
| Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™ |  | 7 Months | 
| Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™ |  | 7 Months | 
| Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ |  | 7 Months | 
| Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ |  | 7 Months | 
| Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ |  | 7 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable Safety Profile |  | 15 days post injection |