The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E

Launched by UNIVERSITY OF CHILE · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E, is studying a new rotavirus vaccine called ROTAVAC 5D. The aim is to see how effective and safe this vaccine is for preventing rotavirus gastroenteritis, which is a common cause of severe diarrhea in infants. The study will involve 5,800 healthy infants in Chile, who will either receive the vaccine or a placebo (a harmless substance with no medical effect) to compare results.

To participate in this trial, infants need to be at least 2 months old and have a parent or guardian who can provide consent and understand the study's details. However, they cannot have received a rotavirus vaccine before, nor should they have certain health conditions like chronic diseases or a known immune deficiency. Throughout the study, blood samples will be taken from some participants to check how well their bodies respond to the vaccine. Parents can expect regular check-ups and monitoring to ensure their child’s safety during the trial, and the study is actively recruiting participants now.

Gender

ALL

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.