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The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E

NCT05958771 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5800

Last updated 2023-07-25

No results posted yet for this study

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.

Conditions

  • Rotavirus Gastroenteritis

Interventions

DRUG

ROTAVAC 5D

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Bharat Biotech International Limited

    collaborator INDUSTRY

  • University of Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05958771 on ClinicalTrials.gov