Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Number of Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV
Outcome Time Frame:
7 Months (Week 4 Postdose 3)
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Denmark: Danish Medicines Agency
Study ID:
2005_093
NCT ID:
NCT00337428
Start Date:
May 2006
Completion Date:
May 2007
Related Keywords:
- Neoplasms, Glandular and Epithelial
- Diphtheria
- Tetanus
- Whooping Cough
- Poliomyelitis
- Neoplasms
- Diphtheria
- Neoplasms, Glandular and Epithelial
- Poliomyelitis
- Tetanus
- Tetany
- Whooping Cough