At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India
In Brief
A Phase 3 clinical trial evaluating Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine for Papillomavirus Infections. Completed, enrolled 110 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomavirus Infections
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2006
Enrollment StartMay 2007
Primary CompletionFeb 2008
TodayJul 2026
First PostedSep 26, 2006
Enrollment StartMay 3, 2007
Primary CompletionFeb 4, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.8 years ago
Interventions
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccinebiological
Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.