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

Last updated: September 27, 2023
Sponsor: International Agency for Research on Cancer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysfunctional Uterine Bleeding

Pelvic Cancer

Vaginal Cancer

Treatment

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.

Clinical Study ID

NCT04588402
SMIMS/IEC/C/2020-09
  • Ages 18-22
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 18 to 22 years, resident of Sikkim and married.
  • Pregnancy will not be considered as exclusion criteria.
  • Sample collection should be avoided during active menstruation.

Exclusion

Exclusion Criteria:

  • Women who do not provide written consent
  • Women who are not able to cooperate in collection of cervical cell sample or respondto questions due to any acute or severe mental and physical illnesses.
  • Women who had undergone hysterectomy.
  • Vaccinated in research project

Study Design

Total Participants: 5500
Treatment Group(s): 1
Primary Treatment: 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.
Phase:
Study Start date:
October 01, 2020
Estimated Completion Date:
December 31, 2025

Study Description

The investigators would like to estimate the prevalence of HPV infections based on cervical samples collected from the Sikkimese women aged 18 to 22 years at baseline (i.e. when the study participants are expected to have no benefit of vaccination) and seven years after the launch of the HPV vaccination programme, by which time the initial vaccinated cohorts will be aged 18 to 22 years and many of them will be sexually active. If the vaccination programme continues with the current high coverage rate, the cohort of women in the second age group are expected to be protected due to herd immunity, irrespective of whether any individual woman receives the vaccine or not. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys.

Connect with a study center

  • Sikkim Manipal Hospital

    Gangtok, Sikkim 737107
    India

    Active - Recruiting

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