Monitoring the effectiveness of HPV vaccination in preventing cervical HPV infection in Sikkim, India
Official title: Assessing the Population Level Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India
Run by International Agency for Research on Cancer · NCT04588402 · Data updated 2026-11-12
This study is testing how well the HPV vaccine works in preventing cervical HPV infections in women aged 18 to 22 in Sikkim, India, by comparing samples taken now and seven years later.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 22 Years |
| Sex | Women only |
| Enrollment | 5500 (estimated) |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Gangtok, Sikkim) |
| Status | Recruiting |
| Started | October 1, 2020 |
| Main results expected | October 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT04588402 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are married women aged 18 to 22 years residing in Sikkim.
✕Probably not a fit
Patients who have undergone a hysterectomy or those who are vaccinated as part of a research project may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to assess the effectiveness of HPV vaccination in real-world conditions, focusing on women aged 18 to 22 years in Sikkim, India. The study will collect cervical samples from participants at baseline and again seven years after the initiation of the HPV vaccination program. By comparing the prevalence of HPV infections over time, the study seeks to provide valuable feedback to public health authorities regarding the impact of the vaccination program. The observational nature of the study means that no interventions will be administered; instead, data will be gathered through sample collection and surveys.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the effectiveness of HPV vaccination, potentially leading to improved cervical cancer prevention strategies.
How similar studies have gone: Other studies have shown success in monitoring HPV vaccination impact, but this specific observational approach in Sikkim is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 Criteria: * Women who do not provide written consent * Women who are not able to cooperate in collection of cervical cell sample or respond to questions due to any acute or severe mental and physical illnesses. * Women who had undergone hysterectomy. * Vaccinated in research project
Where it's running
-
Sikkim Manipal Hospital
Gangtok, Sikkim, India Recruiting
Study contacts
- Principal investigator: Yogesh Verma, MD — Sikkim Manipal Inst., Sikkim, India
- Study coordinator: Partha Basu, MD, PhD
- Email: basup@iarc.fr
- Phone: +33 472 738 167
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.