Efficacy and safety of pentavalent rotavirus vaccine in Japan: A randomized, double-blind, placebo-controlled, multicenter trial

Human Vaccines and Immunotherapeutics

Volumn 9, Issue 8, 2013, Pages 1626-1633

  Iwata, Satoshi ^a   Nakata, Shuji ^b   Ukae, Susumu ^c   Koizumi, Yoshitugu ^d   Morita, Yasuyuki ^e   Kuroki, Haruo ^f   Tanaka, Yoshiyuki ^g   Shizuya, Toshiyuki ^g   Schödel, Florian ^h   Brown, Michelle L ^h   Lawrence, Jody ^h  

^a KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b Nakata Pediatric Clinic   (Japan)

^c Motomachi Urologic Clinic   (Japan)

^d TOHOKU ROSAI HOSPITAL   (Japan)

^e Omagari Pediatric Clinic   (Japan)

^f SOTOBO Children's Clinic   (Japan)

^g Insight KK   (Japan)

^h MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Pentavalent rotavirus vaccine; Rotavirus gastroenteritis; RV5; RVGE; Vaccine

Indexed keywords

PLACEBO; ROTAVIRUS VACCINE;

ARTICLE; BEHAVIOR CHANGE; CONTROLLED STUDY; DEVELOPING COUNTRY; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEALTH CARE COST; HEALTH CARE UTILIZATION; HUMAN; INFANT; INTUSSUSCEPTION; IRRITABILITY; JAPAN; JAPANESE; MALE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; ROTAVIRUS GASTROENTERITIS; SEROTYPE; SIDE EFFECT; VIRAL GASTROENTERITIS; VOMITING;

PENTAVALENT ROTAVIRUS VACCINE; ROTAVIRUS GASTROENTERITIS; RV5; RVGE; VACCINE;

DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; GASTROENTERITIS; HUMANS; INCIDENCE; INFANT; JAPAN; MALE; PLACEBOS; ROTAVIRUS INFECTIONS; ROTAVIRUS VACCINES; SEVERITY OF ILLNESS INDEX; VACCINATION; VACCINES, ATTENUATED;

EID: 84883030183     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.24846     Document Type: Article

References (24)

1. Parashar UD, Burton A, Lanata C, Boschi-Pinto C, Shibuya K, Steele D, et al. Global mortality associated with rotavirus disease among children in 2004. J Infect Dis 2009; 200(Suppl 1):S9-15; PMID:19817620; http://dx.doi.org/10.1086/ 605025
2. Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UD; WHO-coordinated Global Rotavirus Surveillance Network. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136-41; PMID:22030330; http://dx.doi.org/10.1016/S1473-3099(11)70253-5
3. Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, et al.; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354:23-33; PMID:16394299; http://dx.doi.org/10.1056/ NEJMoa052664
4. Bégué RE, Perrin K. Reduction in gastroenteritis with the use of pentavalent rotavirus vaccine in a primary practice. Pediatrics 2010; 126:e40-5; PMID:20587671; http://dx.doi.org/10.1542/peds.2009-2069
5. Curns AT, Steiner CA, Barrett M, Hunter K, Wilson E, Parashar UD. Reduction in acute gastroenteritis hospitalizations among US children after introduction of rotavirus vaccine: analysis of hospital discharge data from 18 US states. J Infect Dis 2010; 201:1617-24; PMID:20402596; http://dx.doi.org/10. 1086/652403
6. Wang FT, Mast TC, Glass RJ, Loughlin J, Seeger JD. Effectiveness of the pentavalent rotavirus vaccine in preventing gastroenteritis in the United States. Pediatrics 2010; 125:e208-13; PMID:20100757; http://dx.doi.org/10.1542/ peds.2009-1246
7. Centers for Disease Control and Prevention (CDC). Reduction in rotavirus after vaccine introduction-United States, 2000-2009. MMWR Morb Mortal Wkly Rep 2009; 58:1146-9; PMID:19847149
8. Boom JA, Tate JE, Sahni LC, Rench MA, Hull JJ, Gentsch JR, et al. Effectiveness of pentavalent rotavirus vaccine in a large urban population in the United States. Pediatrics 2010; 125:e199-207; PMID:20083525; http://dx.doi.org/10.1542/peds.2009-1021
9. Centers for Disease Control and Prevention (CDC). Delayed onset and diminished magnitude of rotavirus activity-United States, November 2007-May 2008. MMWR Morb Mortal Wkly Rep 2008; 57:697-700; PMID:18583958
10. Tate JE, Mutuc JD, Panozzo CA, Payne DC, Cortese MM, Cortes JE, et al. Sustained decline in rotavirus detections in the United States following the introduction of rotavirus vaccine in 2006. Pediatr Infect Dis J 2011; 30(Suppl):S30-4; PMID:21183838; http://dx.doi.org/10.1097/INF.0b013e3181ffe3eb
11. Parashar UD, Alexander J P, Glass RI; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2006; 55(RR-12):1-13; PMID:16902398
12. Field EJ, Vally H, Grimwood K, Lambert SB. Pentavalent rotavirus vaccine and prevention of gastroenteritis hospitalizations in Australia. Pediatrics 2010; 126:e506-12; PMID:20732946; http://dx.doi.org/10.1542/peds.2010-0443
13. Buttery J P, Lambert SB, Grimwood K, Nissen MD, Field EJ, Macartney KK, et al. Reduction in rotavirus-associated acute gastroenteritis following introduction of rotavirus vaccine into Australia's National Childhood vaccine schedule. Pediatr Infect Dis J 2011; 30(Suppl):S25-9; PMID:21183837; http://dx.doi.org/10.1097/INF.0b013e3181fefdee
14. Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, doubleblind, placebo-controlled trial. Lancet 2010; 376:615-23; PMID:20692031; http://dx.doi.org/10.1016/S0140-6736(10)60755-6
15. Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, et al. 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 2010; 376:606-14; PMID:20692030; http://dx.doi.org/10.1016/S0140-6736(10)60889-6
16. Kamiya H, Nakano T, Inoue M, Kamiya H, Abd TT, Patel M, et al. A retrospective evaluation of hospitaliza-tions for acute gastroenteritis at 2 sentinel hospitals in central Japan to estimate the health burden of rotavirus. J Infect Dis 2009; 200(Suppl 1):S140-6; PMID:19817592; http://dx.doi.org/10. 1086/605028
17. Nakagomi T, Nakagomi O, Takahashi Y, Enoki M, Suzuki T, Kilgore PE. Incidence and burden of rotavirus gastroenteritis in Japan, as estimated from a prospective sentinel hospital study. J Infect Dis 2005; 192(Suppl 1):S106-10; PMID:16088792; http://dx.doi.org/10.1086/431503
18. Yokoo M, Arisawa K, Nakagomi O. Estimation of annual incidence, age-specific incidence rate, and cumulative risk of rotavirus gastroenteritis among children in Japan. Jpn J Infect Dis 2004; 57:166-71; PMID:15329449
19. Sato T, Nakagomi T, Nakagomi O. Cost-effectiveness analysis of a universal rotavirus immunization program in Japan. Jpn J Infect Dis 2011; 64:277-83; PMID:21788701
20. RotaTeq™, oral solution. Summary of product characteristics. EMEA/H/C/0669/IB/042. 16-Feb-2013. http://www.ema.europa.eu/docs/en-GB/document- library/EPAR-Summary-for-the-public/human/000669/WC500054181.pdf. Accessed April 19, 2013.
21. Vesikari T, Van Damme P, Giaquinto C, Gray J, Mrukowicz J, Dagan R, et al. European society for paediatric infectious diseases/European society for paediatric gastroenterology, hepatology, and nutrition evidence-based recommendations for rotavirus vaccination in Europe. J Pediatr Gastroenterol Nutr 2008; 46(Suppl 2):S38-48; PMID:18460971; http://dx.doi.org/10.1097/MPG. 0b013e31816f7a10
22. Kamiya H, Nakano T, Kamiya H, Yui A, Taniguchi K, Parashar U; Rotavirus Epidemiology Study Group. Rotavirus-associated acute gastroenteritis hospitaliza-tions among Japanese children aged < 5 years: active rotavirus surveillance in Mie Prefecture, Japan. Jpn J Infect Dis 2011; 64:482-7; PMID:22116326
23. Duffy LC, Byers TE, Riepenhoff-Talty M, La Scolea LJ, Zielezny M, Ogra PL. The effects of infant feeding on rotavirus-induced gastroenteritis: a prospective study. Am J Public Health 1986; 76:259-63; PMID:3004238; http://dx.doi.org/10.2105/AJPH.76.3.259
24. Mast TC, Cai B, Heaton P, Staus WL. Development and validation of an acute gastroenteritis report card and scoring system to measure the clinical severity of acute gastroenteritis in infants. 22nd Annual Meeting of the European Society for Paediatric Infectious Diseases; 2004 May 26-28. Tampere, Finland. Abstract 155. Available at: http://meetings.espid.org/espid2004/ program/session1.asp?SessionId=P07&SSessionDa te=5/27/2004. Accessed March 17, 2013.