Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Partha Basu

Collaborating Sponsors:

All India Institute of Medical Sciences

Cancer Foundation of India

Conditions:

Cervical Cancer

Cervical Precancerous Lesions

Eligibility:

FEMALE

10-18 years

Phase:

PHASE4

Brief 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...

Detailed Description

The suspension of vaccination resulted in girls receiving 3 doses (days 1, 60 and ≥180), receiving 2 doses (days 1 and ≥180), receiving 2 doses at days 1 and 60 due to incomplete treatment ("by defaul...

Eligibility Criteria

Inclusion

  • Apparently healthy, ambulant girls aged 10 - 18 years
  • Unmarried girls
  • Girls with intact uterus
  • Resident in the villages chosen for the study

Exclusion

  • Girls with any severe and/or debilitating illness
  • Past history of allergy to any medication

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2026

Estimated Enrollment :

22729 Patients enrolled

Trial Details

Trial ID

NCT00923702

Start Date

September 1 2009

End Date

July 1 2026

Last Update

September 28 2023

Active Locations (8)

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Page 1 of 2 (8 locations)

1

MNJ Institute of Oncology & Regional Cancer Center

Hyderabad, Andhra Pradesh, India, 500004

2

Gujarat Cancer & Research Institute (GCRI)

Ahmedabad, Gujarat, India, 380 016

3

Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital

Barshi, Maharashtra, India, 413 401

4

Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst

Mumbai, Maharashtra, India, 400 012