Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

Rotavirus Gastroenteritis Clinical Trial

Official title: An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam

Status Completed

Clinical Trial Summary

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam

Clinical Trial Description

• The study is an open labeled, clinical trial in infants 6-8 weeks of age will be assigned to receive 3 doses of Rotavac® to evaluate the immunogenicity and safety.

• Active surveillance will be conducted for all participants for 14 & 28 days after each dose of vaccine to obtain information on adverse events. ("Reactogenicity")

• Childhood vaccines including pentavalent (Diptheria, Tetanus, Pertussis, Hib, Hepatitis B) and oral polio vaccine as well as injectable polio vaccine will be administered along with the study vaccines as per Expanded Program on Immunization (EPI)

• Safety assessments will include observation in the study clinic for 30 minutes after each vaccine administration to record immediate adverse events. A subject diary card and personal contact with the subjects will be made to record adverse events during the 14-day period following vaccine administration. ;

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

• NCT number: NCT04596696
• Study type: Interventional
• Source: Bharat Biotech International Limited
• Status: Completed
• Phase: Phase 3
• Start date: December 20, 2017
• Completion date: June 30, 2019