The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (NCT05958771) | Clinical Trial Compass
UnknownPhase 3
The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E
Chile5,800 participantsStarted 2023-07-06
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.
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 range60 Days – 89 Days
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 at least 2 months at recruitment
* No plans to move in the next 12 months
Exclusion Criteria:
* 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
* 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 (Stable with no on-going medication).
* 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.
What they're measuring
1
Percentage of subject who suffer a moderate-severe rotavirus gastroenteritis in vaccine arm as compared to placebo arm
Timeframe: till 8 months +14 days after administering the third dose