Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants
نویسندگان
چکیده
منابع مشابه
Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.
INTRODUCTION This was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life. MATERIALS AND METHODS Healthy infants, 11 to 17 weeks of age were enrolled in this randomised (1:1), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, ...
متن کاملReactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China
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) age...
متن کاملSafety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy Brazilian infants
Objective: To determine the safety, immunogenicity and efficacy of two doses of rotavirus vaccine in healthy Brazilian infants. Methods: A randomized, multicenter, double-blind, placebo-controlled trial was conducted in Brazil, Mexico and Venezuela. Infants received two oral doses of vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for oral poliomyeli...
متن کاملThe human rotavirus vaccine RotarixTM in infants An integrated analysis of safety and reactogenicity
Rotavirus (RV) is a leading cause of severe acute diarrhea in infants and young children worldwide. RV gastroenteritis (RVGE) accounts for approximately 2.4 million hospitalizations and more than half a million deaths annually among children younger than 5 y. The burden of RV disease varies widely, but is significant in both developing and developed countries. The availability of safe and effec...
متن کاملImmunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants
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 eith...
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ژورنال
عنوان ژورنال: Human Vaccines
سال: 2009
ISSN: 1554-8600,1554-8619
DOI: 10.4161/hv.5.6.8176