Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00923702 |
Recruitment Status :
Active, not recruiting
First Posted : June 18, 2009
Last Update Posted : September 1, 2016
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer Cervical Precancerous Lesions | Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) | Phase 4 |
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 |
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® |
- 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 ]
- Frequency of incident and persistent HPV 16/18/6/11 infection. [ Time Frame: 5 years from the base-line date ]
- Frequency of infection by other non-targeted high-risk HPV types. [ Time Frame: 15 years from the base-line date ]
- Frequency of HPV 16/18-associated precancerous lesions and cancer. [ Time Frame: 15 years from the base-line date ]
- Frequency of cervical neoplasia associated with non-included HPV types. [ Time Frame: 15 years from the base-line date ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
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 |
Principal Investigator: | Rengaswamy Sankaranarayanan, MD | International Agency for Research on Cancer |
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 |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |