A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Summary

The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

Timeline

Start

2003-12

Primary completion

2007-07

Completion

2007-07

Publications

• Background Guillermo M et al. RIX4414 (Rotarix™) has demonstrated efficacy during the first 2 years of life in infants from 11 Latin American countries. Abstract presented at the 10th International Rotavirus Symposium (IRS), Bangkok, Thailand, 19-21 Sep 2012.
• Background Lau YL, Nelson EA, Poon KH, Chan PK, Chiu S, Sung R, Leung CW, Ng D, Ma YM, Chan D, Lee TL, Tang J, Kwan YW, Ip P, Ho M, Fung LW, Tang H, Suryakiran PV, Han HH, Bock H; Hong Kong Rotarix Study Group. Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial. Vaccine. 2013 Apr 26;31(18):2253-9. doi: 10.1016/j.vaccine.2013.03.001. Epub 2013 Mar 13.
• Background Phua KB, Lim FS, Lau YL, Nelson EA, Huang LM, Quak SH, Lee BW, Teoh YL, Tang H, Boudville I, Oostvogels LC, Suryakiran PV, Smolenov IV, Han HH, Bock HL. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine. 2009 Oct 9;27(43):5936-41. doi: 10.1016/j.vaccine.2009.07.098. Epub 2009 Aug 11.
• Background Phua KB et al. Efficacy of rotavirus vaccine RIX4414 during the first 3 years of life: a randomised, double-blind, placebo-controlled study in infants from Hong Kong, Singapore and Taiwan. Abstract presented at the 10th International Rotavirus Symposium (IRS), Bangkok, Thailand, 19-21 Sep 2012.
• Background Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in Asian infants during the first three years of life. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.
• Background Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in infants from Asia during the first two years of life. Abstract presented at the 13th International Congress on Infectious Diseases (ICID). Kuala Lumpur, Malaysia, 19-22 June 2008.
• Background Phua KB et al. Human rotavirus vaccine RIX4414 is highly efficacious in Asian infants during the third year of life. Abstract presented at the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Brussels, Belgium, 9-13 June 2009.
• Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47.

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