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:
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:
Authors: Timo Vesikari; David O Matson; Penelope Dennehy; Pierre Van Damme; Mathuram Santosham; Zoe Rodriguez; Michael J Dallas; Joseph F Heyse; Michelle G Goveia; Steven B Black; Henry R Shinefield; Celia D C Christie; Samuli Ylitalo; Robbin F Itzler; Michele L Coia; Matthew T Onorato; Ben A Adeyi; Gary S Marshall; Leif Gothefors; Dirk Campens; Aino Karvonen; James P Watt; Katherine L O'Brien; Mark J DiNubile; H Fred Clark; John W Boslego; Paul A Offit; Penny M Heaton Journal: N Engl J Med Date: 2006-01-05 Impact factor: 91.245
Authors: Gagandeep Kang; Rashmi Arora; Shobha D Chitambar; Jagdish Deshpande; M D Gupte; Madhuri Kulkarni; Trilok N Naik; Dipali Mukherji; S Venkatasubramaniam; Jon R Gentsch; Roger I Glass; Umesh D Parashar Journal: J Infect Dis Date: 2009-11-01 Impact factor: 5.226