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


Phase 4
10 Years
18 Years
Open (Enrolling)
Female
Cervical Cancer, Cervical Precancerous Lesions

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Geometric mean titers of serum neutralizing antibodies to vaccine included HPV types (16/18/6/11) at 7, 12, 24, 36, 48 months.

Outcome Time Frame:

5 years from the base-line date

Safety Issue:

Yes

Principal Investigator

Rengaswamy Sankaranarayanan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

International Agency for Research on Cancer

Authority:

India: Drugs Controller General of India

Study ID:

BMGF48979

NCT ID:

NCT00923702

Start Date:

September 2009

Completion Date:

May 2014

Related Keywords:

  • Cervical Cancer
  • Cervical Precancerous Lesions
  • Uterine Cervical Neoplasms

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