• Tarun Saluja, Sonali Palkar, Puneet Misra, Madhu Gupta, Potula Venugopal, Ashwani Kumar Sood, Ravi Mandyam Dhati, Avinash Shetty, Sangappa Malappa Dhaded, Sharad Agarkhedkar, Amlan Choudhury, Ramesh Kumar, Sundaram Balasubramanian, Sudhir Babji, Lopa Adhikary, Martin Dupuy, Sangeet Mohan Chadha, Forum Desai, Darshna Kukian, Badri Narayan Patnaik, and Mandeep Singh Dhingra.
• Shantha Biotechnics Pvt. Ltd., Hyderabad, India. Electronic address: Tarun.Saluja@sanofi.com.
• Vaccine. 2017 Jun 16; 35 (28): 3575-3581.

BackgroundRotavirus remains the leading cause of diarrhoea among children <5years. We assessed immunogenic non-inferiority of a tetravalent bovine-human reassortant rotavirus vaccine (BRV-TV) over the licensed human-bovine pentavalent rotavirus vaccine RV5.MethodsPhase III single-blind study (parents blinded) in healthy infants randomized (1:1) to receive three doses of BRV-TV or RV5 at 6-8, 10-12, and 14-16weeks of age. All concomitantly received a licensed diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine (DTwP-HepB-Hib) and oral polio vaccine (OPV). Immunogenic non-inferiority was evaluated in terms of the inter-group difference in anti-rotavirus serum IgA seroresponse (primary endpoint), and seroprotection/seroresponse rates to DTwP-HepB-Hib and OPV vaccines. Seroresponse was defined as a ≥4-fold increase in titers from baseline to D28 post-dose 3. Non-inferiority was declared if the difference between groups (based on the lower limit of the 95% confidence interval [CI]) was above -10%. Each subject was evaluated for solicited adverse events 7days and unsolicited & serious adverse events 28days following each dose of vaccination.ResultsOf 1195 infants screened, 1182 were randomized (590 to BRV-TV; 592 to RV5). Non-inferiority for rotavirus serum IgA seroresponse was not established: BRV-TV, 47.1% (95%CI: 42.8; 51.5) versus RV5, 61.2% (95%CI: 56.8; 65.5); difference between groups, -14.08% (95%CI: -20.4; -7.98). Serum IgA geometric mean concentrations at D28 post-dose 3 were 28.4 and 50.1U/ml in BRV-TV and RV5 groups, respectively. For all DTwP-HepB-Hib and OPV antigens, seroprotection/seroresponse was elicited in both groups and the -10% non-inferiority criterion between groups was met. There were 16 serious adverse events, 10 in BRV-TV group and 6 in RV5 group; none were classified as vaccine related. Both groups had similar vaccine safety profiles.ConclusionBRV-TV was immunogenic but did not meet immunogenic non-inferiority criteria to RV5 when administered concomitantly with routine pediatric antigens in infants.Copyright © 2017 Elsevier Ltd. All rights reserved.

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