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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN98283094
Date of registration: 30/06/2008
Primary sponsor: International Agency for Research on Cancer (IARC) (France)
Public title: Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India N/A
Scientific title:
Date of first enrolment: Jun 1 2008
Target sample size: 16,000 (Amended on 11/04/2012 from 'recruiting' to 'active, but not recruiting')
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN98283094
Study type:  Interventional
Study design:  Two-arm, multicentre, cluster randomised trial (randomisation unit = villages)  
Countries of recruitment
India
Contacts
Name: Rengaswamy  Sankaranarayanan
Address:  150 Cours Albert Thomas 69372 Cedex 08 Lyon France
Telephone: +33 (0)4 72 73 85 14
Email: sankar@iarc.fr
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Apparently healthy, ambulant, unmarried girls aged 10 - 18 years and with intact uterus
2. Resident in the villages chosen for the study

Exclusion criteria: Girls with any severe and/or debilitating illness.

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Cervical precancerous lesions and cervical cancer
Intervention(s)
Vaccination with the prophylactic quadrivalent vaccine of Merck (Gardasil®) which targets HPV 16, 18, 6 and 11 types for prevention of infection with the most common HPV 16 and 18 high risk types and associated cervical intraepithelial neoplasia (CIN).

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 Outcome(s)
1. The relative type specific immunogenicity in terms of the presence of serum neutralising antibodies to HPV 16 and 18 (serum anti-HPV L1 antibody [sL1Ab]) measured using a competitive Luminex immunoassay in blood sample collected from a 15% sample of girls at 7, 12, 24, 36 and 48 months from the first dose of the vaccine
2. HPV 16/18 antibody geometric mean titres (GMTs) induced by the different dose regimes at 7, 12, 24, 36 and 48 months
3. Relative HPV 6/11 type specific immune response in the different regimens in a sample of girls
4. The relative protection in terms of frequency of incident as well as persistent (12-month definition) HPV 16 and 18 infection
5. Frequency of incident infection by other non-targeted high-risk HPV types. Initial follow-up: 5 years. Extended follow-up: 15 years.
6. HPV 16- and 18-associated CIN 2-3, adenocarcinoma in-situ and invasive cancer following the two different dose regimes. Initial follow-up: 5 years. Extended follow-up: 15 years.
7. CIN and invasive cancer associated with non-included HPV types in the two study groups. Initial follow-up: 5 years. Extended follow-up: 15 years.
Secondary Outcome(s)
No secondary outcome measures
Secondary ID(s)
N/A
NCT00923702
Source(s) of Monetary Support
Bill and Melinda Gates Foundation (USA) - through the International Agency for Research on Cancer (IARC), World Health Organization (France)
Secondary Sponsor(s)
N/A
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