Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants.
OBJECTIVE
This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix()) in an Indian setting.


RESULTS
The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups.


METHODS
Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study.


CONCLUSIONS
Two doses of RIX4414 (Rotarix()) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants.


BACKGROUND
ClinicalTrials.gov; NCT00289172; eTrack 103792.
Narang
Anil
A
Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
Bose
Anuradha
A
Pandit
Anand Nilkanth
AN
Dutta
Phalguni
P
Kang
Gagandeep
G
Bhattacharya
Sujit Kumar
SK
Datta
Sanjoy Kumar
SK
Suryakiran
P V
PV
Delem
Andrée
A
Han
Htay Htay
HH
Bock
Hans Ludwig
HL
D000284:Administration, Oral; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D007194:India; D007223:Infant; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D010919:Placebos; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated