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
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
360
Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P\[11\], containing one bovine rotavirus gene P\[11\] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.
Vietnam Military Medical University Hospital
Hanoi, Vietnam
Demonstrate immunogenicity of 3-dose regimen of Rotavac
Immunogenicity of 3-dose regimen of Rotavac with respect to geometric mean titres (GMT) of serum anti-rotavirus IgA at baseline and post-vaccination 4-6 weeks after third dose
Time frame: At the end of 28 days after last dose
Assess and compare reactogenicity and safety (adverse events)
Reactogenicity and safety of Rotavac in terms of adverse event
Time frame: At the end of 28 days after last dose
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