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

About the study

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 take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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 6 to 8 weeks at recruitment
No plans to move in the next 12 months

EXCLUSION CRITERIA

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

5. 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.