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Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Sponsor: Partha Basu
Summary
The primary study hypothesis wasthat 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. The Government of India stopped vaccination in all the HPV vaccine trials in the country in April 2010 due to reasons not related to this study.
Official title: Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Key Details
Gender
FEMALE
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
22729
Start Date
2009-09
Completion Date
2026-07
Last Updated
2023-09-28
Healthy Volunteers
Yes
Interventions
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
Locations (8)
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Andhra Pradesh, India
Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, Gujarat, India
Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital
Barshi, Maharashtra, India
Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst
Mumbai, Maharashtra, India
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd.
Pune, Maharashtra, India
Christian Fellowship Community Health Centre
Ambilikkai, Tamil Nadu, India
Cancer Foundation of India
Kolkata, West Bengal, India
All India Institute of Medical Sciences
New Delhi, India