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

This study is ongoing, but not recruiting participants.
Sponsor:
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 (Responsible Party):
Dr R. Sankaranarayanan, International Agency for Research on Cancer
ClinicalTrials.gov Identifier:
NCT00923702
First received: June 17, 2009
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  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 4

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:

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®

  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
Dr R. Sankaranarayanan
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 R. Sankaranarayanan, Head, Early Detection and Precention Section, 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: March 27, 2012
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 May 21, 2013