Overview

This trial is active, not recruiting.

Conditions cervical cancer, cervical precancerous lesions
Treatment prophylactic quadrivalent hpv vaccine merck (gardasil®)
Phase phase 4
Sponsor Dr R. Sankaranarayanan
Collaborator All India Institute of Medical Sciences, New Delhi
Start date September 2009
End date May 2016
Trial size 20000 participants
Trial identifier NCT00923702, BMGF48979, ISRCTN98283094, REFCTRI-2009 000137

Summary

The primary study hypothesis is that 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
The participants will receive two doses of the vaccine at Day 1 and Day 180.
prophylactic quadrivalent hpv vaccine merck (gardasil®) Gardasil®
The participants will be randomly allocated in equal numbers to receive either two or three doses of the vaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. Girls in the two-dose group will receive the vaccine at Day 1 and Day 180, girls in the three-dose group will receive the vaccine at Day 1, Day 60, and Day 180.
(Other)
The participants will receive three doses of the vaccine at Day 1, Day 60, and Day 180.
prophylactic quadrivalent hpv vaccine merck (gardasil®) Gardasil®
The participants will be randomly allocated in equal numbers to receive either two or three doses of the vaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. Girls in the two-dose group will receive the vaccine at Day 1 and Day 180, girls in the three-dose group will receive the vaccine at Day 1, Day 60, and Day 180.

Primary Outcomes

Measure
Geometric mean titers of serum neutralizing antibodies to vaccine included HPV types (16/18/6/11) at 7, 12, 24, 36, 48 months.
time frame: 5 years from the base-line date
Frequency of incident and persistent HPV 16/18/6/11 infection.
time frame: 5 years from the base-line date

Secondary Outcomes

Measure
Frequency of infection by other non-targeted high-risk HPV types.
time frame: 15 years from the base-line date
Frequency of HPV 16/18-associated precancerous lesions and cancer.
time frame: 15 years from the base-line date
Frequency of cervical neoplasia associated with non-included HPV types.
time frame: 15 years from the base-line date

Eligibility Criteria

Female participants from 10 years up to 18 years old.

Inclusion Criteria: - Apparently healthy, ambulant girls aged 10 - 18 years - Unmarried girls - Girls with intact uterus - Resident in the villages chosen for the study Exclusion Criteria: - Girls with any severe and/or debilitating illness - Past history of allergy to any medication

Additional Information

Official title Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Principal investigator Rengaswamy Sankaranarayanan, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by International Agency for Research on Cancer.