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HPV Vaccine's Real-World impact under the microscope in sikkim

NCT ID NCT04588402

Prevention Sponsor: International Agency for Research on Cancer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checks how well the HPV vaccine prevents cervical HPV infection in women in Sikkim, India, about 7 years after the vaccine was introduced. Researchers will collect cervical samples from 5,500 married women aged 18-22 and compare infection rates to those before vaccination. The goal is to see if the vaccine is working in real life and provide feedback to health authorities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show that the HPV vaccine effectively prevents cervical HPV infection in a real-world setting, supporting its use in public health programs.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only measures infection, not cancer prevention, and is limited to one region.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons.

Ages

18 to 22 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical cancer Uterine Cervical Neoplasms human papilloma virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sikkim Manipal Hospital

    RECRUITING

    Gangtok, Sikkim, 737107, India

More trials for these conditions

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