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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Neoplasms, Glandular and Epithelial; Whooping Cough; Tetanus

Treatments: Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF); Biological: Comparator: REPEVAX™ (Non-Concomitant); Biological: Comparator: REPEVAX™ (Concomitant); Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337428

V501-024

2005_093

Details and patient eligibility

About

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.

Enrollment: 843 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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843 participants in 4 patient groups

Group 1

Experimental group

Description:

Concomitant/CMF

Treatment:

Biological: Comparator: REPEVAX™ (Concomitant)

Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)

Group 2

Experimental group

Description:

Non-Concomitant/CMF

Treatment:

Biological: Comparator: REPEVAX™ (Non-Concomitant)

Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)

Group 3

Experimental group

Description:

Concomitant/FMF

Treatment:

Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)

Biological: Comparator: REPEVAX™ (Concomitant)

Group 4

Experimental group

Description:

Non-Concomitant/FMF

Treatment:

Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)

Biological: Comparator: REPEVAX™ (Non-Concomitant)