Trial Information
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
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
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 Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
Outcome Time Frame:
7 Months
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2005_092
NCT ID:
NCT00325130
Start Date:
April 2006
Completion Date:
April 2007
Related Keywords:
- Neoplasms, Glandular and Epithelial
- Diphtheria
- Tetanus
- Whooping Cough
- Meningitis
- Neoplasms
- Diphtheria
- Meningitis
- Neoplasms, Glandular and Epithelial
- Tetanus
- Tetany
- Whooping Cough