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

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ClinicalTrials.gov Identifier: NCT00923702
Recruitment Status : Active, not recruiting
First Posted : June 18, 2009
Last Update Posted : September 1, 2016
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 Centre
Information provided by (Responsible Party):
Dr R. Sankaranarayanan, International Agency for Research on Cancer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cervical Precancerous Lesions Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Study Start Date : September 2009
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021
Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Frequency of incident and persistent HPV 16/18/6/11 infection. [ Time Frame: 5 years from the base-line date ]

Secondary Outcome Measures :
  1. Frequency of infection by other non-targeted high-risk HPV types. [ Time Frame: 15 years from the base-line date ]
  2. Frequency of HPV 16/18-associated precancerous lesions and cancer. [ Time Frame: 15 years from the base-line date ]
  3. Frequency of cervical neoplasia associated with non-included HPV types. [ Time Frame: 15 years from the base-line date ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923702


Locations
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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 Centre
Investigators
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Principal Investigator: Rengaswamy Sankaranarayanan, MD International Agency for Research on Cancer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr R. Sankaranarayanan, Head, Early Detection and Precention Section, International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT00923702    
Other Study ID Numbers: BMGF48979
ISRCTN98283094 ( Other Identifier: BioMedCentral )
REFCTRI-2009 000137 ( Registry Identifier: Indian Clinical Trial Registry )
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases