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
Phase 3
11 Years
17 Years
11 Years
17 Years
Not Enrolling
Both
Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough, Poliomyelitis
Both
Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough, Poliomyelitis
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
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