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Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

NCT04588402 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5500

Last updated 2026-04-03

No results posted yet for this study

Summary

This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine.

Conditions

Interventions

BIOLOGICAL

The study being observational in nature, there is no intervention. The investigators will only collect cervical samples from married women within a specified age range at different intervals.

Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons. After signing the informed consent, the participants will fill in a risk factor questionnaire to study the socio-demographic information, sexual history and HPV vaccination history and the determinent of HPV infection. The questionnaire will be administered by a trained social worker or nurse. A gynecologist will collect cervical cells from the participant's cervix during a gynecological examination. The cervical specimen will be examined for presence of specific HPV genotypes and Chlamydia infection.

Sponsors & Collaborators

  • Department of Health and Family welfare, Government of Sikkim

    collaborator UNKNOWN

  • Sikkim Manipal Institute

    collaborator UNKNOWN

  • Rajiv Gandhi Centre for Biotechnology

    collaborator INDUSTRY

  • International Agency for Research on Cancer

    lead OTHER

Principal Investigators

  • Yogesh Verma, MD · Sikkim Manipal Inst., Sikkim, India

  • Phumzay Denzongpa, MD · Dept of H & FW, Govt. of Sikkim, India

Eligibility

Min Age
18 Years
Max Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2026-10-30
Completion
2026-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588402 on ClinicalTrials.gov