A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants

References

• Rotavirus vaccines, WHO position paper - January 2013. Wkly Epidemiol Rec. 2013;88(5):49–64.
   PubMedGoogle Scholar
• Troeger C, Blacker BF, Khalil IA, Rao PC, Cao S, Zimsen SR, Albertson SB, Stanaway JD, Deshpande A, Abebe Z, et al. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018;18(11):1211–28. doi:10.1016/s1473-3099(18)30362-1.
   PubMed Web of Science ®Google Scholar
• Troeger C, Khalil IA, Rao PC, Cao S, Blacker BF, Ahmed T, Armah G, Bines JE, Brewer TG, Colombara DV, et al. Rotavirus vaccination and the global burden of rotavirus diarrhea among children younger than 5 years. JAMA Pediatr. 2018;172(10):958–65. doi:10.1001/jamapediatrics.2018.1960.
   PubMed Web of Science ®Google Scholar
• Mehendale S, Venkatasubramanian S, Girish Kumar CP, Kang G, Gupte MD, Arora R. Expanded Indian national rotavirus surveillance network in the context of rotavirus vaccine introduction. Indian Pediatr. 2016;53(7):575–81. doi:10.1007/s13312-016-0891-3.
   PubMed Web of Science ®Google Scholar
• Shrivastava AK, Reddy NS, Giri S, Sahu PS, Das M, Mohakud NK, Das RR. Burden and molecular epidemiology of rotavirus causing diarrhea among under-five children: a hospital-based study from Eastern India. J Glob Infect Dis. 2019;11(4):147–52. doi:10.4103/jgid.jgid_16_19.
   PubMed Web of Science ®Google Scholar
• Goldar S, Rajbongshi G, Chamuah K, Alam ST, Sharma A. Occurrence of viral gastroenteritis in children below 5 years: a hospital-based study from Assam, India. Indian J Med Microbiol. 2019;37(3):415–17. doi:10.4103/ijmm.IJMM_19_79.
   PubMed Web of Science ®Google Scholar
• Giri S, Nair NP, Mathew A, Manohar B, Simon A, Singh T, Suresh Kumar S, Mathew MA, Babji S, Arora R, et al. Rotavirus gastroenteritis in Indian children <5 years hospitalized for diarrhoea, 2012 to 2016. BMC Public Health. 2019;19(1):69. doi:10.1186/s12889-019-6406-0.
   PubMedGoogle Scholar
• Chawla-Sarkar M, Banerjee A, Lo M, Mitra S, Okamoto K, Deb A, Dutta S. A decade-long temporal analyses of human group-A rotavirus among children with gastroenteritis: prevaccination scenario in West Bengal, eastern India. J Med Virol. 2020;92(8):1334–42. doi:10.1002/jmv.25712.
   PubMed Web of Science ®Google Scholar
• Malik A, Haldar P, Ray A, Shet A, Kapuria B, Bhadana S, Santosham M, Ghosh RS, Steinglass R, Kumar R. Introducing rotavirus vaccine in the Universal Immunization Programme in India: from evidence to policy to implementation. Vaccine. 2019;37(39):5817–24. doi:10.1016/j.vaccine.2019.07.104.
   PubMed Web of Science ®Google Scholar
• International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Pneumonia and diarrhea progress report 2020. [accessed 2021 Jan 11]. http://www.jhsph.edu/ivac/wp-content/uploads/2020/11/IVAC_PDPR_2020.pdf.
   Google Scholar
• European Medicines Agency. Rotarix SmPC 24/03/2020 EMA EPAR update. 2020. [accessed 2021 Jan 27]. http://www.ema.europa.eu/en/documents/product-information/rotarix-epar-product-information_en.pdf.
   Google Scholar
• Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 2011;29(11):2079–84. doi:10.1016/j.vaccine.2011.01.004.
   PubMed Web of Science ®Google Scholar
• Kompithra RZ, Paul A, Manoharan D, Babji S, Sarkar R, Mathew LG, Kang G. Immunogenicity of a three dose and five dose oral human rotavirus vaccine (RIX4414) schedule in south Indian infants. Vaccine. 2014;32(Suppl 1):A129–133. doi:10.1016/j.vaccine.2014.03.002.
   PubMed Web of Science ®Google Scholar
• Baker JM, Tate JE, Leon J, Haber MJ, Pitzer VE, Lopman BA. Post-vaccination serum anti-rotavirus immunoglobulin A as a correlate of protection against rotavirus gastroenteritis across settings. J Infect Dis. 2020;222:309–18. doi:10.1093/infdis/jiaa068.
   PubMed Web of Science ®Google Scholar
• Cheuvart B, Neuzil KM, Steele AD, Cunliffe N, Madhi SA, Karkada N, Han HH, Vinals C. Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine. Hum Vaccin Immunother. 2014;10(2):505–11. doi:10.4161/hv.27097.
   PubMed Web of Science ®Google Scholar
• Bernstein DI, Sack DA, Rothstein E, Reisinger K, Smith VE, O’Sullivan D, Spriggs DR, Ward RL. Efficacy of live, attenuated, human rotavirus vaccine 89-12 in infants: a randomised placebo-controlled trial. Lancet. 1999;354(9175):287–90. doi:10.1016/s0140-6736(98)12106-2.
   PubMed Web of Science ®Google Scholar
• Bernstein DI, Smith VE, Sherwood JR, Schiff GM, Sander DS, DeFeudis D, Spriggs DR, Ward RL. Safety and immunogenicity of live, attenuated human rotavirus vaccine 89-12. Vaccine. 1998;16(4):381–87. doi:10.1016/s0264-410x(97)00210-7.
   PubMed Web of Science ®Google Scholar
• Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, et al. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccin. 2009;5(6):414–19. doi:10.4161/hv.5.6.8176.
   PubMed Web of Science ®Google Scholar
• Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4(2):213–26. doi:10.1002/sim.4780040211.
   PubMed Web of Science ®Google Scholar
• Wiedenmayer KA, Weiss S, Chattopadhyay C, Mukherjee A, Kundu R, Aye R, Tediosi F, Hetzel MW, Tanner M. Simplifying paediatric immunization with a fully liquid DTP-HepB-Hib combination vaccine: evidence from a comparative time-motion study in India. Vaccine. 2009;27(5):655–59. doi:10.1016/j.vaccine.2008.11.045.
   PubMed Web of Science ®Google Scholar
• Velasquez A, Dominguez E, Suryakiran P, Delem A, Ortega-Barria E, Han H. Immunogenicity of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) co-administered with childhood vaccinations in Panama. Int J Infect Dis. 2008;12:e148. doi:10.1016/j.ijid.2008.05.368.
   Web of Science ®Google Scholar
• Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011;29(11):2029–36. doi:10.1016/j.vaccine.2011.01.018.
   PubMed Web of Science ®Google Scholar
• Gruber JF, Gruber LM, Weber RP, Becker-Dreps S, Jonsson Funk M. Rotavirus vaccine schedules and vaccine response among infants in low- and middle-income countries: a systematic review. Open Forum Infect Dis. 2017;4(2):ofx066. doi:10.1093/ofid/ofx066.
   PubMed Web of Science ®Google Scholar
• World Health Organization (WHO).Global advisory committee on vaccine safety, 6-7 December 2017. Wkly Epidemiol Rec. 2018;93(3):17–32.
   PubMedGoogle Scholar
• Ella R, Babji S, Ciarlet M, Blackwelder WC, Vadrevu KM. A randomized, open-labelled, non-inferiority phase 4 clinical trial to evaluate the immunogenicity and safety of the live, attenuated, oral rotavirus vaccine, ROTAVAC(R) in comparison with a licensed rotavirus vaccine in healthy infants. Vaccine. 2019;37(31):4407–13. doi:10.1016/j.vaccine.2019.05.069.
   PubMed Web of Science ®Google Scholar
• Rathi N, Desai S, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, et al. A phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine. 2018;36(52):7943–49. doi:10.1016/j.vaccine.2018.11.006.
   PubMed Web of Science ®Google Scholar
• Farooqui HH, Zodpey S. Private sector vaccine share in overall immunization coverage in India: evidence from private sector vaccine utilization data (2012-2015). Indian J Public Health. 2020;64(1):75–78. doi:10.4103/ijph.IJPH_433_18.
   PubMed Web of Science ®Google Scholar