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

M R Lokeshwar, Sheila Bhave, Ashok Gupta, V K Goyal, Anuj Walia

Human vaccines & immunotherapeutics 2013 Jan

filter terms:

To evaluate the immunogenicity and safety of a pentavalent rotavirus vaccine (PRV) in Indian infants. Open-label, single-arm multicentric study. Hospital facilities (out patients): One hundred and ten (110) healthy Indian infants were enrolled between the ages of 6 weeks and 12 weeks. Three doses of oral pentavalent rotavirus vaccine (PRV) were administered with an interval of 4 to 10 weeks (28 to 70 days). 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. 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. A 3-dose regimen of PRV was found to be immunogenic and well tolerated in healthy Indian infants. ClinicalTrials.gov; NCT00496054

Citation

M R Lokeshwar, Sheila Bhave, Ashok Gupta, V K Goyal, Anuj Walia. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Human vaccines & immunotherapeutics. 2013 Jan;9(1):172-6