CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 22,729 enrolled
Drug / intervention
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)biological
Likely dose
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) 20 microgramfrom 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.

Search/NCT00923702
NCT00923702Phase 4Active
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Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

Partha Basu·interventional·Posted Jun 18, 2009·Updated Sep 28, 2023

In Brief

A Phase 4 clinical trial evaluating Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) for Cervical Cancer and Cervical Precancerous Lesions. Active but no longer recruiting, targeting 22,729 participants across 8 sites.

Detailed Summary

The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls against persistent HPV infection and cervical neoplasia caused by HPV types included in the vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the country in April 2010 due to reasons not related to this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Cervical Precancerous Lesions
CountriesIndia
CollaboratorsAll India Institute of Medical Sciences, Cancer Foundation of India, Christian Fellowship Community Health Centre, German Cancer Research Center, Gujarat Cancer & Research Institute, Jehangir Clinical Development Centre, MNJ Institute of Oncology and Regional Cancer Center, Rajiv Gandhi Centre for Biotechnology, Nargis Datta Memorial Cancer Hospital, Tata Memorial Centre

Timeline

Phase 4ActiveOverdue
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2009
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2017
Study CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 17.0 years ago

Interventions

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)biological

The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.