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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

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

Treatments: Biological: Comparator: Adacel™; Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine; Biological: Comparator: Adacel™ (Concomitant); Biological: Comparator: Menactra™ (Concomitant); Biological: Comparator: Menactra™ (Non-concomitant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00325130

2005_092

V501-025

Details and patient eligibility

About

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.

Enrollment: 1,042 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,042 participants in 2 patient groups

Group 1

Experimental group

Description:

Concomitant Administration

Treatment:

Biological: Comparator: Adacel™ (Concomitant)

Biological: Comparator: Menactra™ (Concomitant)

Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine

Group 2

Experimental group

Description:

Non-concomitant administration

Treatment:

Biological: Comparator: Menactra™ (Non-concomitant)

Biological: Comparator: Adacel™

Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine