Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New oral vaccine aims to shield infants from severe rotavirus

NCT ID NCT05958771

Vaccine Sponsor: University of Chile 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This phase 3 study tests whether three doses of an oral rotavirus vaccine (ROTAVAC 5D) can prevent severe diarrhea in healthy infants. Around 4,270 Chilean babies receive either the vaccine or a placebo. Researchers track cases of severe rotavirus gastroenteritis to measure the vaccine's protection.

What this could mean

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

Active substance
live attenuated rotavirus vaccine 116E (ROTAVAC 5D)
What this could lead to
If effective, this vaccine could help protect infants from severe rotavirus diarrhea, reducing hospitalizations and deaths worldwide.
What could go wrong
This is a phase 3 trial, but results may vary by region. The vaccine may not be as effective in different populations or against all rotavirus strains.

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

4,270 people

The number who actually took part.

Started

Jul 2023

Finished

Feb 2026

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.

Ages

60 to 89 days

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: * At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures * Subjects aged at least 2 months at recruitment * No plans to move in the next 12 months Exclusion Criteria: * Administration of rotavirus vaccine in the past * Participants vaccinated with a dose of vaccine from the National Immunization Program corresponding to their current age, in which more than 48 hours have passed since the last dose received * Presence of any illness requiring hospital referral (temporary exclusion) * Known case of immunodeficiency disease, known HIV positive * Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease (Stable with no on-going medication). * Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect) * Diarrhea on the day of enrollment (temporary exclusion) * A known sensitivity or allergy to any components of the study vaccines. * Major congenital or genetic defect. * Has received any immunoglobulin therapy and/or blood products since birth. * History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study, at the discretion of the principal investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rotavirus gastroenteritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Rotavirus infection prevention target

As listed by the trial registrant

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

Rotavirus gastroenteritis

Contacts and locations

Locations

  • CESFAM Colina

    Santiago, Metropolitan Region, Chile

  • CESFAM Dr. Alejandro Gutierrez, Coyahique

    Coyhaique, Aysén, Chile

  • CESFAM Dr. Alejandro del Rio, Puente Alto

    Santiago, Metropolitan Region, Chile

  • CESFAM Esmeralda

    Santiago, Metropolitan Region, Chile

  • CESFAM Jean y Marie Thierry de Valparaíso

    Valparaíso, Valparaiso, Chile

  • CESFAM Lo Barnechea

    Santiago, Metropolitan Region, Chile

  • CESFAM Puerto Aysen

    Puerto Aisén, Aysén, Chile

  • Clínica Dávila

    Santiago, Metropolitan Region, Chile

  • Hospital Base de Osorno

    Osorno, Los Lagos Region, Chile

  • Hospital Dr. Exequiel González Cortés

    Santiago, Metropolitan Region, Chile

  • Hospital Dr. Gustavo Fricke

    Viña del Mar, Chile

  • Hospital Roberto del Rio

    Santiago, Metropolitan Region, Chile

  • Hospital de Carabineros

    Santiago, Metropolitan Region, Chile

  • Hospital de Puerto Montt

    Port Montt, Los Lagos Region, Chile

  • Vacunatorio Kinewen, Concepción

    Concepción, Biobio, Chile

  • Vacunatorio Mediped

    Antofagasta, Antofagasta, 124 3817, Chile

More trials for these conditions

Other studies related to the condition(s) this trial covers.