Active — Not RecruitingPhase 3

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

Chile5,800 participantsStarted 2023-07-07

Plain-language 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.

Who can participate

Age range6 Weeks – 8 Weeks

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

To evaluate the efficacy of ROTAVAC5D

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

Trial details

NCT IDNCT06200844

SponsorBharat Biotech International Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-04

View on ClinicalTrials.gov More Rotavirus Infection of Children trials