The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants

NCT06200844 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: BBIL/Rotavac 5D-CHILE /2022
• Study Type: interventional
• Target: 5,800
• Locations: 1 country
• Sites: 16

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 aged 6-8 weeks. 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 Infection of Children

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of ROTAVAC5D

  Efficacy of ORV 116E in comparison to a placebo against moderate-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, that requires overnight hospitalization or rehydration therapy equivalent to World Health Organization (WHO) plan B (oral rehydration therapy) or plan C (intravenous rehydration therapy) in a medical facility such as a hospital, clinic, or supervised rural health care center

  14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].

Secondary Outcomes (10)

• Efficacy of Severe rotavirus gastroenteritis (>11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus occurring at least 14 days following the third dose

  Till the age of 12 months + up to 14 days

• To evaluate the efficacy of a ROTAVAC 5D against any severity of rotavirusgastroenteritis

  Till the age of 1 year (12 months) + up to 14 days

• To evaluate the efficacy of ROTAVAC 5D for rotavirus only gastroenteritis (absence of co-pathogens)

  Throughout study period i.e.,30 months

• To evaluate the efficacy of a ROTAVAC 5D against any severity of gastroenteritis irrespective of etiology

  till the age of 1 year (12 months) + up to 14 days

• To evaluate the efficacy of ROTAVAC 5D against severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology

  From 14 days following the 3rd dose till the age of 1 year (12months) + up to 14 days

Study Arms (2)

Rotavac 5D

EXPERIMENTAL

Rotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 10 power 5.0 FFU and administered as a three-dose regimen, 4 weeks apart.

Biological: ROTAVAC 5D

Placebo

PLACEBO COMPARATOR

Placebo administered as a three-dose regimen, 4 weeks apart.

Other: Placebo

Interventions

ROTAVAC 5D BIOLOGICAL

Rotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 105.0 FFU and administered as a three-dose regimen, 4 weeks apart.

Rotavac 5D

Placebo OTHER

Placebo is administered as three doses 4 weeks apart

Placebo

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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 6 to 8 weeks at recruitment
• No plans to move in the next 12 months

You may not qualify if:

• Administration of rotavirus vaccine in the past
• Known case of immunodeficiency disease, known HIV positive
• Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease
• 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (16)

Vacunatorio Mediped

Antofagasta, 1240000, Chile

Location

Vacunatorio Kinewen

Concepción, 4070118, Chile

Location

CESFAM Dr. Alejandro Gutierrez

Coyhaique, 5950000, Chile

Location

Hospital de Puerto Montt

Los Lagos, 5480000, Chile

Location

Hospital Base Osorno ,Av. Guillermo Buhler 1765

Osorno, 5290000, Chile

Location

CESFAM Puerto Aysen

Puerto Aisén, 6000594, Chile

Location

Centro de Salud Familiar CESFAM Rosita Renard

Santiago, 7500539, Chile

Location

Hospital de Carabineros

Santiago, 7770201, Chile

Location

Consultorio Dr. Alejandro del Rio

Santiago, 8210269, Chile

Location

Hospital de ninos Roberto del Rio

Santiago, 8380418, Chile

Location

CESFAM Esmeralda

Santiago, 9340000, Chile

Location

CESFAM Colina

Santiago, 9350079, Chile

Location

CESFAM Lo Barnechea

Santiago, Chile

Location

Hospital Exequiel Gónzalez Cortés

Santiago, Chile

Location

CESFAM Jean y Marie Thierry de Valparaíso

Valparaíso, 2340319, Chile

Location

Hospital Gustavo Fricke

Viña del Mar, 2520000, Chile

Location

Study Officials

• Dr.V.Krishna Mohan, PhD

  Bharat Biotech International Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 11, 2024
• Study Start: July 7, 2023
• Primary Completion: January 4, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (16)