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Clinical Trial
. 2016 Mar 3;12(3):785-93.
doi: 10.1080/21645515.2015.1085143.

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

Rong-Cheng Li  1 , Teng Huang  1 , Yanping Li  1 , Lao-Hong Wang  2 , Junhui Tao  3 , Botao Fu  4 , Guoai Si  5 , Yi Nong  1 , Zhaojun Mo  1 , XueYan Liao  6 , Ivy Luan  6 , Haiwen Tang  6 , Niraj Rathi  7 , Naveen Karkada  7 , Htay Htay Han  8
Affiliations
Clinical Trial

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

Rong-Cheng Li et al. Hum Vaccin Immunother. .

Abstract

This study evaluated the immunogenicity of the human rotavirus (RV) vaccine (RIX4414) when co-administered with routine childhood vaccines in Chinese infants (NCT01171963). Healthy infants aged 6-16 weeks received 2 doses of either RIX4414 or placebo according to a 0, 1-month schedule. Infants received routine diphtheria-tetanus-acellular pertussis (DTPa) and oral poliovirus (OPV) vaccines either separately from or concomitantly with RIX4414/placebo (separate and co-administration cohorts, respectively). Anti-RV IgA seroconversion rates (one month post-dose-2) and seropositivity rates (at one year of age) were measured using ELISA. Immune responses against the DTPa and OPV antigens were measured one month post-DTPa dose-3 in the co-administration cohort. Solicited local and general symptoms were recorded for 8-days post-vaccination (total cohort). The according-to-protocol immunogenicity population included 511 infants in the separate cohort and 275 in the co-administration cohort. One month post-RIX4414 dose-2, anti-RV IgA seroconversion rates were 74.7% (95% confidence interval [CI]: 68.9-79.9) and 64.2% (95% CI: 55.4-72.3) in the separate and co-administration cohorts; seropositivity rates at one year of age were 71.5% (95% CI: 65.5-77.1) and 50.0% (95% CI: 40.9-59.1), respectively. One month post-DTPa dose-3, all infants in the co-administration cohort were seroprotected against diphtheria and tetanus, and seropositive for pertussis toxoid, pertactin and filamentous haemaglutinin. Two months post-OPV dose-3, seroprotection rates against anti-poliovirus types 1, 2 and 3 were >99% in the co-administration cohort. Reactogenicity profiles were similar in both cohorts. RIX4414 was immunogenic and well-tolerated in Chinese infants and did not appear to interfere with the immunogenicity and reactogenicity of co-administered routine childhood vaccines.

Keywords: China; DTPa; OPV; RIX4414; immunogenicity; reactogenicity; rotavirus; routine childhood vaccines.

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Figures

Figure 1.
Figure 1.
Study profile for immunogenicity cohorts.
Figure 2.
Figure 2.
Anti-RV IgA seroconversion (one month post-dose-2)/seropositivity rates (at one year of age) and GMCs in seropositive subjects (separate and co-administration cohort [vaccine group]) (ATP- cohort): (a) Seroconversion / Seropositivity rates; (b) GMCs.
Figure 3.
Figure 3.
Time points of vaccine administration and blood sampling.
See this image and copyright information in PMC

References

    1. 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 - DOI - PubMed
    1. 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 - DOI - PubMed
    1. Rotavirus vaccines . WHO position paper - January 2013. Wkly Epidemiol Rec 2013; 88:49-64; PMID:23424730 - PubMed
    1. 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 - DOI - PubMed
    1. 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 - DOI - PubMed

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