drugset / Trial / NCT01171963
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
Timeline
- Start
- 2010-08-29
- Primary completion
- 2012-05-12
- Completion
- 2012-05-12
Publications
- Li RC, Huang T, Li Y, Luo D, Tao J, Fu B, Si G, Nong Y, Mo Z, Liao X, Luan I, Tang H, Rathi N, Karkada N, Han HH. 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):11-8. doi: 10.4161/hv.26319. Epub 2013 Sep 6.
- Li RC, Li YP, Mo ZJ, Luo D, Huang T, Kong JL, Wang LH, Song NS, Liu A, Zhang H, Liao X, Karkada N, Han HH. 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. doi: 10.4161/hv.25076. Epub 2013 Jun 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oral poliovirus vaccine (OPV) | Vaccine | — | Oral |
| Subject | RIX4414 | Vaccine | — | Oral |
| Background | Adacel | Vaccine | — | Intramuscular |