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Abstract
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
Disclosure of Potential Conflicts of Interest
No potential conflicts of interest were disclosed.
Acknowledgments
We are indebted to the infants and their parents/guardians who participated in this study. We are also thankful to Michelle Goveia, MD for the expert review of this manuscript (Senior Medical Director at Merck and Co., Inc., Whitehouse Station). This study was sponsored by Merck and Co., Inc., Whitehouse Station.