Immunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants

References

• Kawai K, O'Brien MA, Goveia MG, Mast TC, El Khoury AC. Burden of rotavirus gastroenteritis and distribution of rotavirus strains in Asia: a systematic review. Vaccine 2012; 30:1244-54; PMID:22212128; http://dx.doi.org/10.1016/j.vaccine.2011.12.092
   PubMed Web of Science ®Google Scholar
• Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UD. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136-41; PMID:22030330; http://dx.doi.org/10.1016/S1473-3099(11)70253-5
   PubMed Web of Science ®Google Scholar
• Rotavirus vaccines. WHO position paper - January 2013. Wkly Epidemiol Rec 2013; 88:49-64; PMID:23424730
   PubMedGoogle Scholar
• Yee EL, Fang ZY, Liu N, Hadler SC, Liang X, Wang H, Zhu X, Jiang B, Parashar U, Widdowson MA, et al. Importance and challenges of accurately counting rotavirus deaths in China, 2002. Vaccine 2009; 27 Suppl 5:F46-9; PMID:19931719; http://dx.doi.org/10.1016/j.vaccine.2009.08.065
   PubMedGoogle Scholar
• Duan ZJ, Liu N, Yang SH, Zhang J, Sun LW, Tang JY, Jin Y, Du ZQ, Xu J, Wu QB, et al. Hospital-based surveillance of rotavirus diarrhea in the People's Republic of China, August 2003-July 2007. J Infect Dis 2009; 200 Suppl 1:S167-73; PMID:19817597; http://dx.doi.org/10.1086/605039
   PubMedGoogle Scholar
• Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354:11-22; PMID:16394298; http://dx.doi.org/10.1056/NEJMoa052434
   PubMed Web of Science ®Google Scholar
• Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354:23-33; PMID:16394299; http://dx.doi.org/10.1056/NEJMoa052664
   PubMed Web of Science ®Google Scholar
• Soares-Weiser K, Maclehose H, Bergman H, Ben-Aharon I, Nagpal S, Goldberg E, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Sys Rev 2012; 11:CD008521
   PubMed Web of Science ®Google Scholar
• He Q, Wang M, Xu J, Zhang C, Wang H, Zhu W, Fu C. Rotavirus vaccination coverage among children aged 2-59 months: a report from Guangzhou, China. PloS One 2013; 8:e68169; PMID:23840828; http://dx.doi.org/10.1371/journal.pone.0068169
   PubMedGoogle Scholar
• Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics 2008; 122:e1062-6; PMID:18977955; http://dx.doi.org/10.1542/peds.2008-1059
   PubMed Web of Science ®Google Scholar
• Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Thollot F, Garcia-Corbeira P, Damaso S, Han HH, Bouckenooghee A. Immunogenicity and safety of the human rotavirus vaccine Rotarix co-administered with routine infant vaccines following the vaccination schedules in Europe. Vaccine 2010; 28:5272-9; PMID:20538094; http://dx.doi.org/10.1016/j.vaccine.2010.05.057
   PubMed Web of Science ®Google Scholar
• Steele AD, De Vos B, Tumbo J, Reynders J, Scholtz F, Bos P, de Beer MC, Van der Merwe CF, Delem A. Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines. Vaccine 2010; 28:6542-8; PMID:18786585; http://dx.doi.org/10.1016/j.vaccine.2008.08.034
   PubMed Web of Science ®Google Scholar
• Li RC, Huang T, Li Y, Luo D, Tao J, Fu B, Si G, Nong Y, Mo Z, Liao X, et al. Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: A randomized, placebo-controlled trial in China. Hum Vaccin Immunother 2014; 10:1-8; PMID:24832715; http://dx.doi.org/10.4161/hv.28050
   PubMed Web of Science ®Google Scholar
• Zaman K, Sack DA, Yunus M, Arifeen SE, Podder G, Azim T, Luby S, Breiman RF, Neuzil K, Datta SK, et al. Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age. Vaccine 2009; 27:1333-9; PMID:19162114; http://dx.doi.org/10.1016/j.vaccine.2008.12.059
   PubMed Web of Science ®Google Scholar
• Madhi SA, Kirsten M, Louw C, Bos P, Aspinall S, Bouckenooghe A, Neuzil KM, Steele AD. Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine 2012; 30 Suppl 1:A44-51; PMID:22520136; http://dx.doi.org/10.1016/j.vaccine.2011.08.080
   PubMed Web of Science ®Google Scholar
• Patel M, Steele AD, Parashar UD. Influence of oral polio vaccines on performance of the monovalent and pentavalent rotavirus vaccines. Vaccine 2012; 30 Suppl 1:A30-5; PMID:22520134; http://dx.doi.org/10.1016/j.vaccine.2011.11.093
   PubMed Web of Science ®Google Scholar
• Steele AD, Reynders J, Scholtz F, Bos P, de Beer MC, Tumbo J, Van der Merwe CF, Delem A, De Vos B. Comparison of 2 different regimens for reactogenicity, safety, and immunogenicity of the live attenuated oral rotavirus vaccine RIX4414 coadministered with oral polio vaccine in South African infants. J Infect Dis 2010; 202 Suppl:S93-100; PMID:20684724; http://dx.doi.org/10.1086/653550
   PubMed Web of Science ®Google Scholar
• Tregnaghi MW, Abate HJ, Valencia A, Lopez P, Da Silveira TR, Rivera, L, Medina DMR, Saez-Llorens X, Ayala SEG, De Leon T, et al. Human rotavirus vaccine is highly efficacious when co-administered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J 2011; 30(6): p.e103-8; PMID:21378594
   PubMed Web of Science ®Google Scholar
• Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine 2011; 29:6335-41; PMID:21640780; http://dx.doi.org/10.1016/j.vaccine.2011.05.017
   PubMed Web of Science ®Google Scholar
• Kim JS, Bae CW, Lee KY, Park MS, Choi YY, Kim KN, Kim JD, Park WS, Sin JB, Kim EA, et al. Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study. Human vaccines & immunotherapeutics 2012; 8:806-12; PMID:22699440; http://dx.doi.org/10.4161/hv.19853
   PubMed Web of Science ®Google Scholar
• Phua KB, Emmanuel SC, Goh P, Quak SH, Lee BW, Han HH, Ward RL, Bernstein DI, De Vos B, Bock HL. A rotavirus vaccine for infants: the Asian experience. Ann Acad Med Singapore 2006; 35:38-44; PMID:16470273
   PubMed Web of Science ®Google Scholar
• Lau YL, Nelson EA, Poon KH, Chan PK, Chiu S, Sung R, Leung CW, Ng D, Ma YM, Chan D. Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: A randomized, controlled trial. Vaccine 2013; 31:2253-9; PMID:23499605; http://dx.doi.org/10.1016/j.vaccine.2013.03.001
   PubMed Web of Science ®Google Scholar
• Steele AD, De Vos B, Tumbo J, Reynders J, Scholtz F, Bos P, de Beer MC, Van der Merwe CF, Delem A. Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines. Vaccine 2010; 28:6542-8; PMID:18786585; http://dx.doi.org/10.1016/j.vaccine.2008.08.034
   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; 5:414-9; PMID:19276664; http://dx.doi.org/10.4161/hv.5.6.8176
   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; 10:505-11; PMID:24240068; http://dx.doi.org/10.4161/hv.27097
   PubMed Web of Science ®Google Scholar
• Salinas B, Perez Schael I, Linhares AC, Ruiz Palacios GM, Guerrero ML, Yarzabal JP, Cervantes Y, Clemens C, Damaso S, Hardt K, et al. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J 2005; 24:807-16; PMID:16148848; http://dx.doi.org/10.1097/01.inf.0000178294.13954.a1
   PubMed Web of Science ®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; 29:2079-84; PMID:21238572; http://dx.doi.org/10.1016/j.vaccine.2011.01.004
   PubMed Web of Science ®Google Scholar
• Cheuvart B, Friedland LR, Abu-Elyazeed R, Han HH, Guerra Y, Verstraeten T. The human rotavirus vaccine RIX4414 in infants: a review of safety and tolerability. Pediatr Infect Dis J 2009; 28:225-32; PMID:19209095; http://dx.doi.org/10.1097/INF.0b013e31819715fa
   PubMed Web of Science ®Google Scholar
• Camargo ME, Silveira L, Furuta JA, Oliveira EP, Germek OA. Immunoenzymatic assay of anti-diphtheric toxin antibodies in human serum. J Clin Microbiol 1984; 20:772-4; PMID:6386879
   PubMed Web of Science ®Google Scholar
• Melville-Smith ME, Seagroatt VA, Watkins JT. A comparison of enzyme-linked immunosorbent assay (ELISA) with the toxin neutralisation test in mice as a method for the estimation of tetanus antitoxin in human sera. J Biol Stand 1983; 11:137-44; PMID:6345548; http://dx.doi.org/10.1016/S0092-1157(83)80038-9
   PubMedGoogle Scholar
• Riffelmann M, Thiel K, Schmetz J, Wirsing von Koenig CH. Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis. J Clin Microbiol 2010; 48:4459-63; PMID:20943873; http://dx.doi.org/10.1128/JCM.01371-10
   PubMed Web of Science ®Google Scholar
• World Health Organization Expanded Programme on Immunization. Guidelines for WHO/EPI collaborative studies on poliomyelitis: standard procedure for determining immunity to poliovirus using the microneutralization test. Geneva: World Health Organization 1993
   Google Scholar