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

This study has been suspended.

( Temporarily suspended: waiting for Indian Governement clearance )

First Received on June 17, 2009. Last Updated on June 4, 2010 History of Changes

Sponsor:	International Agency for Research on Cancer
Collaborators:	All India Institute of Medical Sciences, New Delhi Cancer Foundation of India Christian Fellowship Community Health Centre Deutsches Krebsforschungszentrum (DKFZ) Gujarat Cancer & Research Institute Jehangir Clinical Development Centre MNJ Institute of Oncology & Regional cancer Center Rajiv Gandhi Centre for Biotechnology Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst
Information provided by:	International Agency for Research on Cancer
ClinicalTrials.gov Identifier:	NCT00923702

Purpose

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.

Condition	Intervention	Phase
Cervical Cancer Cervical Precancerous Lesions	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by International Agency for Research on Cancer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Frequency of incident and persistent HPV 16/18/6/11 infection. [ Time Frame: 5 years from the base-line date ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency of infection by other non-targeted high-risk HPV types. [ Time Frame: 15 years from the base-line date ] [ Designated as safety issue: Yes ]
Frequency of HPV 16/18-associated precancerous lesions and cancer. [ Time Frame: 15 years from the base-line date ] [ Designated as safety issue: Yes ]
Frequency of cervical neoplasia associated with non-included HPV types. [ Time Frame: 15 years from the base-line date ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20000
Study Start Date:	September 2009
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2 doses of vaccine The participants will receive two doses of the vaccine at Day 1 and Day 180.	Biological: Prophylactic quadrivalent HPV vaccine Merck (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 Name: Gardasil®
3 doses of vaccine The participants will receive three doses of the vaccine at Day 1, Day 60, and Day 180.	Biological: Prophylactic quadrivalent HPV vaccine Merck (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 Name: Gardasil®

Arms

Assigned Interventions

2 doses of vaccine

The participants will receive two doses of the vaccine at Day 1 and Day 180.

Biological: Prophylactic quadrivalent HPV vaccine Merck (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 Name: Gardasil®

3 doses of vaccine

The participants will receive three doses of the vaccine at Day 1, Day 60, and Day 180.

Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Other Name: Gardasil®

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923702

Locations

India
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Andhra Pradesh, India, 500004
Cancer Foundation of India
Kolkata, Bengal, India, 700031
Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, Gujarat, India, 380 016
Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital
Barshi, Maharashtra, India, 413 401
Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst
Mumbai, Maharashtra, India, 400 012
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd.
Pune, Maharashtra, India, 411 001
Christian Fellowship Community Health Centre
Ambilikkai, Tamil Nadu, India, 624612
All India Institute of Medical Sciences
New Delhi, India, 110029

Sponsors and Collaborators

International Agency for Research on Cancer

All India Institute of Medical Sciences, New Delhi

Cancer Foundation of India

Christian Fellowship Community Health Centre

Deutsches Krebsforschungszentrum (DKFZ)

Gujarat Cancer & Research Institute

Jehangir Clinical Development Centre

MNJ Institute of Oncology & Regional cancer Center

Rajiv Gandhi Centre for Biotechnology

Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital

Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst

Investigators

Principal Investigator:

Rengaswamy Sankaranarayanan, MD

International Agency for Research on Cancer

More Information

No publications provided

Responsible Party:	Dr Rengaswamy Sankaranarayanan, International Agency for Research on Cancer
ClinicalTrials.gov Identifier:	NCT00923702 History of Changes
Other Study ID Numbers:	BMGF48979, ISRCTN98283094, REFCTRI-2009 000137
Study First Received:	June 17, 2009
Last Updated:	June 4, 2010
Health Authority:	India: Drugs Controller General of India; India: Indian Council of Medical Research; India: Ministry of Health

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012