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Clinical Trial
. 2013 Aug;9(8):1638-42.
doi: 10.4161/hv.25076. Epub 2013 Jun 4.

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies

Rong-Cheng Li  1 , Yan-Ping Li, Zhao-Jun Mo, Dong Luo, Teng Huang, Ji-Lian Kong, Lao-Hong Wang, Ning-Sheng Song, Aixue Liu, Helen Zhang, Xueyan Liao, Naveen Karkada, Htay Htay Han
Affiliations
Clinical Trial

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies

Rong-Cheng Li et al. Hum Vaccin Immunother. 2013 Aug.

Abstract

We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China. Healthy adults aged 18-45 y (n=48) and children aged 2-6 y (n=50) received a single dose of the human RV vaccine or placebo. Healthy infants (n=50) aged 6-16 weeks at the time of first vaccination received two oral doses of the human RV vaccine or placebo according to a 0, 1 mo schedule. In infants, blood samples were collected prior to vaccination and one month post-dose 2 to assess anti-RV IgA antibody concentrations using ELISA. Stool samples were collected from all infants on the day of each vaccination, at 7 and 15 d after each vaccination and one month post-dose 2. Stool samples were analyzed by ELISA for detection of RV antigen to assess RV antigen excretion. The reactogenicity profile of the human RV vaccine was found to be comparable to that of placebo in all age groups studied. The anti-RV IgA antibody seroconversion rate in infants after two vaccine doses was 86.7% (95% CI: 59.5-98.3). Vaccine take in infants who received the liquid human RV vaccine was 86.7% (95% CI: 59.5-98.3). A Phase III efficacy study of the human RV vaccine in the infant population in China has now been completed (ROTA-075/NCT01171963).

Keywords: RIX4414; human rotavirus vaccine; rotavirus gastroenteritis; rotavirus vaccination; vaccine safety.

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References

    1. Bresee J, Fang ZY, Wang B, Nelson EA, Tam J, Soenarto Y, et al. Asian Rotavirus Surveillance Network First report from the Asian Rotavirus Surveillance Network. Emerg Infect Dis. 2004;10:988–95. doi: 10.3201/eid1006.030519. - DOI - PMC - PubMed
    1. Fang ZY, Wang B, Kilgore PE, Bresee JS, Zhang LJ, Sun LW, et al. Sentinel hospital surveillance for rotavirus diarrhea in the People’s Republic of China, August 2001-July 2003. J Infect Dis. 2005;192(Suppl 1):S94–9. doi: 10.1086/431505. - DOI - PubMed
    1. Orenstein EW, Fang ZY, Xu J, Liu C, Shen K, Qian Y, et al. The epidemiology and burden of rotavirus in China: a review of the literature from 1983 to 2005. Vaccine. 2007;25:406–13. doi: 10.1016/j.vaccine.2006.07.054. - DOI - PubMed
    1. Naghipour M, Nakagomi T, Nakagomi O. Issues with reducing the rotavirus-associated mortality by vaccination in developing countries. Vaccine. 2008;26:3236–41. doi: 10.1016/j.vaccine.2008.04.004. - DOI - PubMed
    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. doi: 10.1016/j.vaccine.2011.12.092. - DOI - PubMed

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