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Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

NCT00923702 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22729

Last updated 2023-09-28

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Cancer Foundation of India

    collaborator OTHER

  • Christian Fellowship Community Health Centre

    collaborator OTHER

  • German Cancer Research Center

    collaborator OTHER

  • Gujarat Cancer & Research Institute

    collaborator OTHER

  • Jehangir Clinical Development Centre

    collaborator OTHER

  • MNJ Institute of Oncology and Regional Cancer Center

    collaborator OTHER_GOV

  • Rajiv Gandhi Centre for Biotechnology

    collaborator INDUSTRY

  • Nargis Datta Memorial Cancer Hospital

    collaborator OTHER

  • Tata Memorial Centre

    collaborator OTHER

  • Partha Basu

    lead OTHER

Principal Investigators

  • Partha Basu, MD · International Agency for Research on Cancer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2017-01-31
Completion
2026-07-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923702 on ClinicalTrials.gov