The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E
Rotavirus Gastroenteritis
About this trial
This is an interventional prevention trial for Rotavirus Gastroenteritis
Eligibility Criteria
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.
Sites / Locations
- Vacunatorio MedipedRecruiting
- Hospital Base de OsornoRecruiting
- Hospital de Puerto MonttRecruiting
- Hospital Roberto del RioRecruiting
- Hospital Dr. Gustavo FrickeRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Children who receive the IP
Children who receive placebo
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.
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.