Clinical Trials Directory

Trials / Completed

CompletedNCT00380367

Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)

Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
110 (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
Female
Age
9 Years – 15 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.

Conditions

Interventions

TypeNameDescription
BIOLOGICALQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineQuadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

Timeline

Start date
2007-05-03
Primary completion
2008-02-04
Completion
2008-02-04
First posted
2006-09-26
Last updated
2023-05-31
Results posted
2009-04-14

Source: ClinicalTrials.gov record NCT00380367. Inclusion in this directory is not an endorsement.