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

NCT05958771 | Unknown Phase 3 DMC

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

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.

Conditions

Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Percentage of subject who suffer a moderate-severe rotavirus gastroenteritis in vaccine arm as compared to placebo arm

  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

  till 8 months +14 days after administering the third dose

Secondary Outcomes (12)

• Percentage of subject who suffer a severe rotavirus gastroenteritis according to the Vesikari Score 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

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 5D DRUG

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

Placebo DRUG

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

Children who receive placebo

Eligibility Criteria

• Age: 60 Days - 89 Days
• 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 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.

Sponsors & Collaborators

• University of Chile: lead
• Bharat Biotech International Limited: collaborator

Study Sites (5)

Vacunatorio Mediped

Antofagasta, Antofagasta, 124 3817, Chile

RECRUITING

Hospital Base de Osorno

Osorno, Los Lagos Region, Chile

RECRUITING

Hospital de Puerto Montt

Port Montt, Los Lagos Region, Chile

RECRUITING

Hospital Roberto del Rio

Santiago, Metropolitan Region, Chile

RECRUITING

Hospital Dr. Gustavo Fricke

Viña del Mar, Chile

RECRUITING

Central Study Contacts

Veronica De la Maza, Licence

CONTACT

56 9 77647257; vdelamaza@uchile.cl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 25, 2023
• Study Start: July 6, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

CL (5)