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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


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

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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

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