Condition category
Cancer
Date applied
17/03/2008
Date assigned
30/06/2008
Last edited
16/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rengaswamy Sankaranarayanan

ORCID ID

Contact details

150 Cours Albert Thomas
Lyon
69372 Cedex 08
France
+33 (0)4 72 73 85 14
sankar@iarc.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00923702

Protocol/serial number

N/A

Study information

Scientific title

Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India

Acronym

Study hypothesis

The primary study hypothesis is that a two-dose human papillomavirus (HPV) vaccine regimen over six months would offer similar immunogenicity and protection as that of a three-dose regimen to girls against infection and cervical neoplasia caused by HPV types included in the vaccine and any oncogenic HPV types.

Ethics approval

International Agency for Research on Cancer (IARC) Institutional Review Board, 18/02/2008

Study design

Two-arm multicentre cluster randomised trial (randomisation unit = villages)

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Cervical precancerous lesions and cervical cancer

Intervention

Vaccination with the prophylactic quadrivalent vaccine of Merck (GardasilĀ®) 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.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

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 measures

No secondary outcome measures

Overall trial start date

01/06/2008

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Child

Gender

Female

Target number of participants

16,000

Participant exclusion criteria

Girls with any severe and/or debilitating illness

Recruitment start date

01/06/2008

Recruitment end date

11/04/2012

Locations

Countries of recruitment

India

Trial participating centre

150 Cours Albert Thomas
Lyon
69372 Cedex 08
France

Sponsor information

Organisation

International Agency for Research on Cancer (IARC) (France)

Sponsor details

World Health Organization
150 cours Albert Thomas
Lyon
69372 cedex 08
France
+33 (0)4 72 73 85 14
sankar@iarc.fr

Sponsor type

Government

Website

http://screening.iarc.fr

Funders

Funder type

Research organisation

Funder name

Bill and Melinda Gates Foundation (USA) - through the International Agency for Research on Cancer (IARC), World Health Organization (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26652797

Publication citations

Additional files

Editorial Notes