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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
360
Rotavac® is in frozen form and is thawed till fully liquid prior to administration.
Thai Binh Health Center
Thái Bình, Vietnam
Frequency and rate of the AEs within 30 minutes after vaccination
Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination
Time frame: 30 minutes after vaccination
Frequency and rate of the AEs within 7 days after vaccination
Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination
Time frame: for 7 days after each vaccination
Frequency and rate of the AEs during 28 days after vaccination
Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination
Time frame: for 28 days after vaccination
Frequency and rate of the SAEs during 28 days after vaccination
Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination
Time frame: for 28 days after vaccination
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