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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.
Hum Vaccin Immunother. 2013 Aug; 9(8):1638-42.HV

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).

Authors+Show Affiliations

Guangxi Autonomous Region Center for Disease Prevention and Control; Nanning City, Guangxi, P.R. China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23807360

Citation

Li, Rong-Cheng, et al. "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." Human Vaccines & Immunotherapeutics, vol. 9, no. 8, 2013, pp. 1638-42.
Li RC, Li YP, Mo ZJ, et al. 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. Hum Vaccin Immunother. 2013;9(8):1638-42.
Li, R. C., Li, Y. P., Mo, Z. J., Luo, D., Huang, T., Kong, J. L., Wang, L. H., Song, N. S., Liu, A., Zhang, H., Liao, X., Karkada, N., & Han, H. H. (2013). 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. Human Vaccines & Immunotherapeutics, 9(8), 1638-42. https://doi.org/10.4161/hv.25076
Li RC, et al. 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. Hum Vaccin Immunother. 2013;9(8):1638-42. PubMed PMID: 23807360.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Li,Rong-Cheng, AU - Li,Yan-Ping, AU - Mo,Zhao-Jun, AU - Luo,Dong, AU - Huang,Teng, AU - Kong,Ji-Lian, AU - Wang,Lao-Hong, AU - Song,Ning-Sheng, AU - Liu,Aixue, AU - Zhang,Helen, AU - Liao,Xueyan, AU - Karkada,Naveen, AU - Han,Htay Htay, Y1 - 2013/06/04/ PY - 2013/6/29/entrez PY - 2013/6/29/pubmed PY - 2014/5/7/medline KW - RIX4414 KW - human rotavirus vaccine KW - rotavirus gastroenteritis KW - rotavirus vaccination KW - vaccine safety SP - 1638 EP - 42 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 9 IS - 8 N2 - 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). SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/23807360/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_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.25076 DB - PRIME DP - Unbound Medicine ER -