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Can one visit cover HPV and tetanus protection? a phase 3 trial puts the question to the test

NCT ID NCT07824310

Prevention Sponsor: PT Bio Farma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether a quadrivalent HPV vaccine can be given at the same time as a tetanus-diphtheria booster in healthy children and adolescents aged 9 to 15 in Indonesia. The trial compares children who receive both vaccines together with those who receive the HPV vaccine alone. The main question is whether the combined schedule produces an HPV immune response that is not lower than the HPV-only schedule.

What this could mean

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

Active substance
A quadrivalent HPV vaccine given together with a tetanus-diphtheria booster vaccine
What this could lead to
If co-administration works, children could receive HPV and tetanus-diphtheria protection in fewer clinic visits, which may make it easier to complete both vaccine schedules.
What could go wrong
The trial may show that giving the two shots together weakens the immune response to HPV compared with giving the HPV vaccine alone. Combining vaccines can also increase short-term side effects like soreness or fever, and results in Indonesian children may not apply everywhere.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 266 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

9 to 15 years

Sex

Anyone

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: 1. Age 9-15 years; 2. Healthy; 3. Subject/parent or LAR appropriately informed and consent/assent signed; 4. Willing to comply with investigator instructions and study schedule. Exclusion Criteria: 1. Concurrent/other trial; 2. Evolving illness/fever ≥37.5°C; 3. Allergy to vaccine components; 4. Uncontrolled coagulopathy/blood disorder contraindicating IM injection; 5. Recent treatment likely to alter immune response; 6. Pregnancy/breastfeeding; 7\. Abnormality/chronic disease interfering with objectives; 8. History of HPV/diphtheria/tetanus infection; 9. Previous HPV vaccination.

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Conditions

The condition(s) this trial relates to.

Infections human papilloma virus infection prevention target

As listed by the trial registrant

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

Human papillomavirus (HPV) infection

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

  • RSUD Dr. Soetomo

    Surabaya, East Java, Indonesia

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