Evaluating a new oral rotavirus vaccine in infants

The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.

This study is testing a new oral rotavirus vaccine in healthy infants to see if it is safe and effective at preventing the virus.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 5800 (estimated)
• Ages: 60 Days to 89 Days
• Sex: All
• Sponsor: University of Chile (other)
• Locations: 5 sites (Antofagasta, Antofagasta Region and 4 other locations)
• Trial ID: NCT05958771 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial aims to assess the efficacy, safety, and immunogenicity of the ROTAVAC 5D, a live attenuated oral rotavirus vaccine, in healthy infants. A total of 5800 infants from Chile will be randomly assigned to receive either the vaccine or a placebo in a 1:1 ratio. The study will also include an immunogenicity cohort of 300 participants, from whom blood samples will be collected to evaluate the immune response. The infants will receive three doses of the vaccine alongside their routine childhood vaccinations.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged at least 2 months who have not previously received a rotavirus vaccine.

Not a fit: Patients who have received a rotavirus vaccine in the past or have certain chronic illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of rotavirus gastroenteritis in infants, leading to better health outcomes.

How similar studies have performed: Previous studies on rotavirus vaccines have shown success, indicating a promising potential for this approach.

Eligibility criteria

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.

Where this trial is running

Antofagasta, Antofagasta Region and 4 other locations

• Vacunatorio Mediped — Antofagasta, Antofagasta Region, Chile (RECRUITING)
• Hospital Base de Osorno — Osorno, Los Lagos Region, Chile (RECRUITING)
• Hospital de Puerto Montt — Puerto Montt, Los Lagos Region, Chile (RECRUITING)
• Hospital Roberto del Rio — Santiago, Metropolitan Region, Chile (RECRUITING)
• Hospital Dr. Gustavo Fricke — Viña Del Mar, Chile (RECRUITING)

Study contacts

• Study coordinator: Veronica De la Maza, Licence

Conditions: Rotavirus Gastroenteritis