Status:
ACTIVE_NOT_RECRUITING
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Lead Sponsor:
Bharat Biotech International Limited
Conditions:
Rotavirus Infection of Children
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
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 ...
Detailed Description
The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants. This is a randomized, double-blind, phase 3 study to evaluate the Efficacy, Safety, and Im...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Administration of rotavirus vaccine in the past
- 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
- 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.
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
5800 Patients enrolled
Trial Details
Trial ID
NCT06200844
Start Date
July 7 2023
End Date
July 1 2026
Last Update
May 22 2025
Active Locations (16)
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1
Vacunatorio Mediped
Antofagasta, Chile, 1240000
2
Vacunatorio Kinewen
Concepción, Chile, 4070118
3
CESFAM Dr. Alejandro Gutierrez
Coyhaique, Chile, 5950000
4
Hospital de Puerto Montt
Los Lagos, Chile, 5480000