Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants.

Objective: To evaluate the immunogenicity and safety of a pentavalent rotavirus vaccine (PRV) in Indian infants.

Study Design: Open-label, single-arm multicentric study.

Setting: Hospital facilities (out patients):

Subjects: One hundred and ten (110) healthy Indian infants were enrolled between the ages of 6 weeks and 12 weeks.

Intervention: Three doses of oral pentavalent rotavirus vaccine (PRV) were administered with an interval of 4 to 10 weeks (28 to 70 days).

Main Outcome Measures: Immunogenicity of PRV was based on the proportion of infants exhibiting a > 3-fold rise in serum anti rotavirus IgA antibodies (from pre dose 1 to 14 days post dose 3). Safety was evaluated for 14 days after each dose.

Results: Of the 110 infants enrolled, 83% exhibited at least a 3-fold rise (seroconversion) in serum anti rotavirus IgA antibodies. There were no clinically significant adverse events reported.

Conclusions: A 3-dose regimen of PRV was found to be immunogenic and well tolerated in healthy Indian infants.

Clinical Trials Registration: ClinicalTrials.gov; NCT00496054: