Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial

The Lancet - Tập 376 - Trang 615-623 - 2010
K Zaman1, Dang Duc Anh2, John C Victor3, Sunheang Shin4, Md Yunus1, Michael J Dallas5, Goutam Podder1, Vu Dinh Thiem2, Le Thi Phuong Mai2, Stephen P Luby1, Le Huu Tho6, Michele L Coia5, Kristen Lewis3, Stephen B Rivers5, David A Sack7, Florian Schödel5, A Duncan Steele8, Kathleen M Neuzil3, Max Ciarlet5
1International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh
2National Institute of Hygiene and Epidemiology, Ministry of Health, Hanoi, Vietnam
3PATH, Seattle, WA, USA
4International Vaccine Institute, Seoul, Korea
5Merck Research Laboratories, North Wales, PA, USA
6Khanh Hoa Health Service, Nha Trang, Vietnam
7Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
8Initiative for Vaccine Research, WHO, Geneva, Switzerland

Tài liệu tham khảo

Parashar, 2009, Global mortality associated with rotavirus disease among children in 2004, J Infect Dis, 200, S9, 10.1086/605025 Bresee, 1999, Current status and future priorities for rotavirus vaccine development, evaluation and implementation in developing countries, Vaccine, 17, 2207, 10.1016/S0264-410X(98)00376-4 Vesikari, 2006, Safety and efficacy of pentavalent human-bovine (WC3) reassortant rotavirus vaccine in preventing rotavirus gastroenteritis and reducing associated health care resource utilization, N Engl J Med, 354, 23, 10.1056/NEJMoa052664 Ruis-Palacios, 2006, Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis, N Engl J Med, 345, 11, 10.1056/NEJMoa052434 Phua, 2009, Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomized, double-blind, controlled study, Vaccine, 48, 5936, 10.1016/j.vaccine.2009.07.098 2006, Conclusions and recommendations from the Immunization Strategic Advisory Group, Wkly Epidemiol Rec, 32, 2 DiStefano, 2005, Novel rotavirus VP7 typing assay using a one-step reverse transcriptase PCR protocol and product sequencing and utility of the assay for epidemiological studies and strain characterization, including serotype subgroup analysis, J Clin Microbiol, 43, 5876, 10.1128/JCM.43.12.5876-5880.2005 Ciarlet, 2008, Concomitant use of the oral pentavalent human bovine reassortant rotavirus vaccine and oral poliovirus vaccine, Pediatric Infect Dis J, 27, 874, 10.1097/INF.0b013e3181782780 Ward, 1997, Serologic correlates of immunity in a tetravalent reassortant rotavirus vaccine trial, J Infect Dis, 176, 570, 10.1086/514076 Knowlton, 1991, Development of an improved method for measuring neutralizing antibody to rotavirus, J Virol Methods, 33, 127, 10.1016/0166-0934(91)90013-P Ruuska, 1990, Rotavirus disease in Finnish children: use of numerical scores for clinical severity of diarrhoeal episodes, Scand J Infect Dis, 22, 259, 10.3109/00365549009027046 Chan, 1998, Exact power and sample size for vaccine efficacy studies, Commun Stat Theory Methods, 27, 1305, 10.1080/03610929808832160 Miettinen, 1985, Comparative analysis of two rates, Stat Med, 4, 213, 10.1002/sim.4780040211 Block, 2007, Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life, Pediatrics, 119, 11, 10.1542/peds.2006-2058 Vesikari, 2007, Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization based on data from 11 countries, International J Infect Dis, 11, S29, 10.1016/S1201-9712(07)60019-8 Ciarlet, 2009, Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq®, Vaccine, 27, G72, 10.1016/j.vaccine.2009.09.107 2008, 8 Health Statistics Report. Division of Health Statistics and Informatics, Department of Planning and Finance, Ministry of Health of Vietnam: Hanoi, Vietnam, 2005. 2007, Rotavirus vaccines, Wkly Epidemiol Rec, 82, 285 Vesikari, 2006, Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants, Vaccine, 24, 4821, 10.1016/j.vaccine.2006.03.025 Armah, 2010, Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial, Lancet, 10.1016/S0140-6736(10)60889-6 Patel, 2009, Oral rotavirus vaccines: how well will they work where they are needed most?, J Infect Dis, 200, S39, 10.1086/605035 Zaman, 2009, Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age, Vaccine, 27, 1333, 10.1016/j.vaccine.2008.12.059 Rennels, 1996, Concurrent oral poliovirus and rhesus-human reassortant rotavirus vaccination: effects on immune responses to both vaccines and on efficacy of rotavirus vaccines, J Infect Dis, 173, 306, 10.1093/infdis/173.2.306 Steele, 2009, Rotavirus vaccines for infants in developing countries in Africa and Asia: considerations from a World Health Organization-sponsored consultation, J Infect Dis, 200, S63, 10.1086/605042 Madhi, 2010, Effect of human rotavirus vaccine on severe diarrhea in African infants, N Engl J Med, 362, 289, 10.1056/NEJMoa0904797 Patel, 2009, Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua, JAMA, 310, 2243, 10.1001/jama.2009.756 2009, Reduction in rotavirus after vaccine introduction—United States, 2000–2009, MMWR Morb Mortal Wkly Rep, 58, 1146 Palma, 2010, Effectiveness of rotavirus vaccination against childhood diarrhoea in El Salvador: case-control study, BMJ, 341, c2825, 10.1136/bmj.c2825 2009, Meeting of the immunization Strategic Advisory Group of Experts, April 2009—conclusions and recommendations, Wkly Epidemiol Rec, 84, 220 2009, Rotavirus vaccines: an update, Wkly Epidemiol Rec, 84, 533 Atherly, 2009, Rotavirus vaccination: cost-effectiveness and impact on child mortality in developing countries, J Infect Dis, 200, S28, 10.1086/605033