Brief Summary

This is a randomized, double-blind, phase 3 study to evaluate the Efficacy, Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants. A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,270

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2023

Typical duration for phase_3

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

June 23, 2023

Completed

13 days until next milestone

Study Start

First participant enrolled

July 6, 2023

Completed

19 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2.6 years

First QC Date

June 23, 2023

Last Update Submit

June 25, 2026

Conditions

Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

Percentage of subject who suffer a severe rotavirus gastroenteritis according to the Vesikari Score in vaccine arm as compared to placebo
Efficacy of ORV 116E in comparison to a placebo against severe rotavirus gastroenteritis defined as: episode of diarrhea (the passage of three or more loose or watery stools within a 24-hour period), with or without vomiting, with Vesikari score ≥11
till 8 months +14 days after administering the third dose

Secondary Outcomes (12)

Percentage of subject who suffer a moderate-to-severe rotavirus gastroenteritis according to WHO rehydration plan in vaccine arm as compared to placebo
till 8 months +14 days after administering the third dose
Percentage of subject who suffer any severity of rotavirus gastroenteritis according to the Vesikari score in vaccine arm as compared to placebo arm
till 8 months +14 days after administering the third dose
Percentage of subject who suffer moderate-severe rotavirus-only gastroenteritis (absence of co-pathogens) in vaccine arm as compared to placebo arm
till 8 months +14 days after administering the third dose
Percentage of subject who suffer severe (according to Vesikari score) rotavirus-only gastroenteritis (absence of co-pathogens) in vaccine arm as compared to placebo arm
till 8 months +14 days after administering the third dose
Percentage of subject who suffer any severity (according to Vesikari score) of rotavirus-only gastroenteritis (absence of co-pathogens) in vaccine arm as compared to placebo arm
till 8 months +14 days after administering the third dose
+7 more secondary outcomes

Other Outcomes (1)

Immunogenicity rates after 3 doses of vaccine as compared to placebo arm.
28 (+) 5 days after the third dose in comparison to baseline levels

Study Arms (2)

Children who receive the IP

ACTIVE COMPARATOR

The Test Article/placebo will be co-administered with the childhood vaccines that are scheduled at the regular National Program of Immunization vaccination visits around 2 months, 4 months and 6 months of age. Test article: ROTAVAC 5D, 3 doses. Each dose of 0.5 mL. Administered orally.

Drug: ROTAVAC 5D

Children who receive placebo

PLACEBO COMPARATOR

The Test Article/placebo will be co-administered with the childhood vaccines that are scheduled at the regular National Program of Immunization vaccination visits around 2 months, 4 months and 6 months of age. Placebo: 3 doses. Each dose of 0.5 mL. Administered orally.

Drug: Placebo

Interventions

ROTAVAC 5DDRUG

monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells. Each dose contains NLT 10 e 5.0 FFU

Children who receive the IP

PlaceboDRUG

Placebo contains all the excipients of ROTAVAC 5D but without the suspension of live attenuated rotavirus

Children who receive placebo

Eligibility Criteria

Age60 Days - 89 Days

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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
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).
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Chilelead
Bharat Biotech International Limitedcollaborator

Study Sites (16)

Vacunatorio Mediped

Antofagasta, Antofagasta, 124 3817, Chile

Location

CESFAM Dr. Alejandro Gutierrez, Coyahique

Coyhaique, Aysén, Chile

Location

CESFAM Puerto Aysen

Puerto Aisén, Aysén, Chile

Location

Vacunatorio Kinewen, Concepción

Concepción, Biobio, Chile

Location

Hospital Base de Osorno

Osorno, Los Lagos Region, Chile

Location

Hospital de Puerto Montt

Port Montt, Los Lagos Region, Chile

Location

CESFAM Colina