메뉴 건너뛰기




Volumn 208, Issue 3, 2013, Pages 423-431

Efficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal period

Author keywords

attenuated; diarrhea; gastroenteritis; Ghana; humans; infant; infantile; randomized controlled trial; rotavirus; rotavirus infections; rotavirus vaccines; vaccines

Indexed keywords

PLACEBO; REASSORTANT ROTAVIRUS TETRAVALENT VACCINE; ROTAVIRUS VACCINE; UNCLASSIFIED DRUG;

EID: 84880239202     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jit174     Document Type: Article
Times cited : (49)

References (48)
  • 1
    • 84856217709 scopus 로고    scopus 로고
    • 2008 estimate of worldwide ro-tavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: A systematic review and meta-analysis
    • Tate J, Burton A, Boschi-Pinto C, et al. 2008 estimate of worldwide ro-tavirus-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 2011; 12:136-41.
    • (2011) Lancet Infect Dis , vol.12 , pp. 136-141
    • Tate, J.1    Burton, A.2    Boschi-Pinto, C.3
  • 2
    • 16544366154 scopus 로고    scopus 로고
    • Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants
    • Vesikari T, Karvonen A, Puustinen L, et al. Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr Infect Dis J 2004; 23:937-43.
    • (2004) Pediatr Infect Dis J , vol.23 , pp. 937-943
    • Vesikari, T.1    Karvonen, A.2    Puustinen, L.3
  • 3
    • 36248995945 scopus 로고    scopus 로고
    • Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: Randomised, double-blind controlled study
    • Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet 2007; 370:1757-63.
    • (2007) Lancet , vol.370 , pp. 1757-1763
    • Vesikari, T.1    Karvonen, A.2    Prymula, R.3
  • 4
    • 76049110309 scopus 로고    scopus 로고
    • Effectiveness of pentavalent rotavirus vaccine in a large urban population in the United States
    • Boom JA, Tate JE, Sahni LC, et al. Effectiveness of pentavalent rotavirus vaccine in a large urban population in the United States. Pediatrics 2010; 125:e199-207.
    • (2010) Pediatrics , vol.125
    • Boom, J.A.1    Tate, J.E.2    Sahni, L.C.3
  • 5
    • 79960805267 scopus 로고    scopus 로고
    • Effectiveness of pentavalent rotavirus vaccine against severe disease
    • Staat MA, Payne DC, Donauer S, et al. Effectiveness of pentavalent rotavirus vaccine against severe disease. Pediatrics 2011; 128:e267-75.
    • (2011) Pediatrics , vol.128
    • Staat, M.A.1    Payne, D.C.2    Donauer, S.3
  • 6
    • 75449098835 scopus 로고    scopus 로고
    • Effect of human rotavirus vaccine on severe diarrhea in African infants
    • Madhi SA, Cunliffe NA, Steele D, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med 2010; 362:289-98.
    • (2010) N Engl J Med , vol.362 , pp. 289-298
    • Madhi, S.A.1    Cunliffe, N.A.2    Steele, D.3
  • 7
    • 77956055765 scopus 로고    scopus 로고
    • Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: A randomised, double-blind, placebo-controlled trial
    • Zaman K, Dang DA, Victor JC, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 376:615-23.
    • (2010) Lancet , vol.376 , pp. 615-623
    • Zaman, K.1    Dang, D.A.2    Victor, J.C.3
  • 8
    • 77956063814 scopus 로고    scopus 로고
    • 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
    • Armah GE, Sow SO, Breiman RF, 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.
    • (2010) Lancet , vol.376 , pp. 606-614
    • Armah, G.E.1    Sow, S.O.2    Breiman, R.F.3
  • 10
    • 79960849653 scopus 로고    scopus 로고
    • Protective effect of natural rotavirus infection in an Indian birth cohort
    • Gladstone BP, Ramani S, Mukhopadhya I, et al. Protective effect of natural rotavirus infection in an Indian birth cohort. N Engl J Med 2011; 365:337-46.
    • (2011) N Engl J Med , vol.365 , pp. 337-346
    • Gladstone, B.P.1    Ramani, S.2    Mukhopadhya, I.3
  • 11
    • 34548519302 scopus 로고    scopus 로고
    • Withdrawal of rotavirus vaccine recommendation
    • Centers for Disease Control and Prevention.
    • Centers for Disease Control and Prevention. Withdrawal of rotavirus vaccine recommendation. MMWR Morb Mortal Wkly Rep 1999; 48:1007.
    • (1999) MMWR Morb Mortal Wkly Rep , vol.48 , pp. 1007
  • 12
    • 0035236196 scopus 로고    scopus 로고
    • A rotavirus vaccine for prevention of severe diarrhoea of infants and young children: Development, utilization and withdrawal
    • discussion 171-9
    • Kapikian AZ. A rotavirus vaccine for prevention of severe diarrhoea of infants and young children: development, utilization and withdrawal. Novartis Found Symp 2001; 238:153-71; discussion 171-9.
    • (2001) Novartis Found Symp , vol.238 , pp. 153-171
    • Kapikian, A.Z.1
  • 13
    • 0035902195 scopus 로고    scopus 로고
    • Intussusception among infants given an oral rotavirus vaccine.[Erratum appears in
    • May 17 Note: Livingood, JR [corrected to Livengood, JR]]. N Engl J Med 2001 344 564-72
    • Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine.[Erratum appears in N Engl J Med 2001 May 17;344(20):1564 Note: Livingood, JR [corrected to Livengood, JR]]. N Engl J Med 2001; 344:564-72.
    • (2001) N Engl J Med , vol.344 , Issue.20 , pp. 1564
    • Murphy, T.V.1    Gargiullo, P.M.2    Massoudi, M.S.3
  • 14
    • 0037446785 scopus 로고    scopus 로고
    • Reappraisal of the association of intussusception with the licensed live rotavirus vaccine challenges initial conclusions
    • Murphy BR, Morens DM, Simonsen L, Chanock RM, La Montagne JR, Kapikian AZ. Reappraisal of the association of intussusception with the licensed live rotavirus vaccine challenges initial conclusions. J Infect Dis 2003; 187:1301-8.
    • (2003) J Infect Dis , vol.187 , pp. 1301-1308
    • Murphy, B.R.1    Morens, D.M.2    Simonsen, L.3    Chanock, R.M.4    La Montagne, J.R.5    Kapikian, A.Z.6
  • 15
    • 0345269167 scopus 로고    scopus 로고
    • The first rotavirus vaccine and intussusception: Epidemiological studies and policy decisions
    • Murphy TV, Smith PJ, Gargiullo PM, Schwartz B. The first rotavirus vaccine and intussusception: epidemiological studies and policy decisions. J Infect Dis 2003; 187:1309-13.
    • (2003) J Infect Dis , vol.187 , pp. 1309-1313
    • Murphy, T.V.1    Smith, P.J.2    Gargiullo, P.M.3    Schwartz, B.4
  • 16
    • 84862515072 scopus 로고    scopus 로고
    • History of rotavirus vaccines part I: RotaShield
    • Plotkin S, ed New York: Springer
    • Kapikian A. History of rotavirus vaccines part I: RotaShield. In: Plotkin S, ed. History of vaccine development. New York: Springer 2011:285-314.
    • (2011) History of Vaccine Development , pp. 285-314
    • Kapikian, A.1
  • 17
    • 79959320244 scopus 로고    scopus 로고
    • Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil
    • Patel MM, Lopez-Collada VR, Bulhoes MM, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Engl J Med 2011; 364:2283-92.
    • (2011) N Engl J Med , vol.364 , pp. 2283-2292
    • Patel, M.M.1    Lopez-Collada, V.R.2    Bulhoes, M.M.3
  • 20
    • 79953186891 scopus 로고    scopus 로고
    • Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia
    • Buttery JP, Danchin MH, Lee KJ, et al. Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine 2011; 29:3061-6.
    • (2011) Vaccine , vol.29 , pp. 3061-3066
    • Buttery, J.P.1    Danchin, M.H.2    Lee, K.J.3
  • 22
    • 84862744065 scopus 로고    scopus 로고
    • Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico
    • Velazquez FR, Colindres RE, Grajales C, et al. Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico. Pediatr Infect Dis J 2012; 31:736-44.
    • (2012) Pediatr Infect Dis J , vol.31 , pp. 736-744
    • Velazquez, F.R.1    Colindres, R.E.2    Grajales, C.3
  • 23
    • 23944442798 scopus 로고    scopus 로고
    • More on RotaShield and intussusception: The role of age at the time of vaccination
    • Simonsen L, Viboud C, Elixhauser A, Taylor RJ, Kapikian AZ. More on RotaShield and intussusception: the role of age at the time of vaccination. J Infect Dis 2005; 192 (Suppl 1):S36-43.
    • (2005) J Infect Dis , vol.192 , Issue.SUPPL. 1
    • Simonsen, L.1    Viboud, C.2    Elixhauser, A.3    Taylor, R.J.4    Kapikian, A.Z.5
  • 24
    • 23944481418 scopus 로고    scopus 로고
    • A hexavalent human rotavi-rus-bovine rotavirus (UK) reassortant vaccine designed for use in developing countries and delivered in a schedule with the potential to eliminate the risk of intussusception
    • Kapikian AZ, Simonsen L, Vesikari T, et al. A hexavalent human rotavi-rus-bovine rotavirus (UK) reassortant vaccine designed for use in developing countries and delivered in a schedule with the potential to eliminate the risk of intussusception. J Infect Dis 2005; 192 (Suppl 1): S22-9.
    • (2005) J Infect Dis , vol.192 , Issue.SUPPL. 1
    • Kapikian, A.Z.1    Simonsen, L.2    Vesikari, T.3
  • 25
    • 33644923193 scopus 로고    scopus 로고
    • Age dependence of the relation between reassortant rotavirus vaccine (RotaShield) and intussusception
    • author reply 898-9
    • Rothman KJ, Young-Xu Y, Arellano F. Age dependence of the relation between reassortant rotavirus vaccine (RotaShield) and intussusception. J Infect Dis 2006; 193:898; author reply 898-9.
    • (2006) J Infect Dis , vol.193 , pp. 898
    • Rothman, K.J.1    Young-Xu, Y.2    Arellano, F.3
  • 26
    • 30044438810 scopus 로고    scopus 로고
    • Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis
    • Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354:11-22.
    • (2006) N Engl J Med , vol.354 , pp. 11-22
    • Ruiz-Palacios, G.M.1    Perez-Schael, I.2    Velazquez, F.R.3
  • 27
    • 30044442208 scopus 로고    scopus 로고
    • Safety and efficacy of a penta-valent human-bovine (WC3) reassortant rotavirus vaccine
    • Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a penta-valent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354:23-33.
    • (2006) N Engl J Med , vol.354 , pp. 23-33
    • Vesikari, T.1    Matson, D.O.2    Dennehy, P.3
  • 28
    • 33845388297 scopus 로고    scopus 로고
    • Is there a safe age for vaccinating infants with tetravalent rhesus-human reassortant rotavirus vaccine?
    • Gargiullo PM, Murphy TV, Davis RL. Is there a safe age for vaccinating infants with tetravalent rhesus-human reassortant rotavirus vaccine? J Infect Dis 2006; 194:1793-4.
    • (2006) J Infect Dis , vol.194 , pp. 1793-1794
    • Gargiullo, P.M.1    Murphy, T.V.2    Davis, R.L.3
  • 29
    • 44449164088 scopus 로고    scopus 로고
    • Trends in intussusception hospi-talizations among US infants, 1993-2004: Implications for monitoring the safety of the new rotavirus vaccination program
    • Tate JE, Simonsen L, Viboud C, et al. Trends in intussusception hospi-talizations among US infants, 1993-2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics 2008; 121:e1125-32.
    • (2008) Pediatrics , vol.121
    • Tate, J.E.1    Simonsen, L.2    Viboud, C.3
  • 30
    • 84860244914 scopus 로고    scopus 로고
    • Potential intussusception risk versus health benefits from rotavirus vaccination in Latin America
    • Desai R, Parashar UD, Lopman B, et al. Potential intussusception risk versus health benefits from rotavirus vaccination in Latin America. Clin Infect Dis 2012; 54:1397-405.
    • (2012) Clin Infect Dis , vol.54 , pp. 1397-1405
    • Desai, R.1    Parashar, U.D.2    Lopman, B.3
  • 31
    • 33746362943 scopus 로고    scopus 로고
    • Safety, efficacy, and immuno-genicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children
    • Vesikari T, Karvonen AV, Majuri J, et al. Safety, efficacy, and immuno-genicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children. J Infect Dis 2006; 194:370-6.
    • (2006) J Infect Dis , vol.194 , pp. 370-376
    • Vesikari, T.1    Karvonen, A.V.2    Majuri, J.3
  • 32
    • 63149130849 scopus 로고    scopus 로고
    • Burden of acute gastroenteritis hospitalizations and emergency department visits in US children that is potentially preventable by rotavirus vaccination: A probe study using the now-withdrawn rotashield vaccine
    • Tate JE, Curns AT, Cortese MM, et al. Burden of acute gastroenteritis hospitalizations and emergency department visits in US children that is potentially preventable by rotavirus vaccination: a probe study using the now-withdrawn rotashield vaccine. Pediatrics 2009; 123:744-9.
    • (2009) Pediatrics , vol.123 , pp. 744-749
    • Tate, J.E.1    Curns, A.T.2    Cortese, M.M.3
  • 33
    • 77955679207 scopus 로고    scopus 로고
    • Epidemiology of rotavirus infection in children in Blantyre, Malawi, 1997-2007
    • Cunliffe NA, Ngwira BM, Dove W, et al. Epidemiology of rotavirus infection in children in Blantyre, Malawi, 1997-2007. J Infect Dis 2010; 202 (Suppl):S168-74.
    • (2010) J Infect Dis , vol.202 , Issue.SUPPL.
    • Cunliffe, N.A.1    Ngwira, B.M.2    Dove, W.3
  • 34
    • 0022220580 scopus 로고
    • The efficacy of DPT and oral poliomyelitis immunization schedules initiated from birth to 12 weeks of age
    • Halsey N, Galazka A. The efficacy of DPT and oral poliomyelitis immunization schedules initiated from birth to 12 weeks of age. B World Health Organ 1985; 63:1151-1169.
    • (1985) B World Health Organ , vol.63 , pp. 1151-1169
    • Halsey, N.1    Galazka, A.2
  • 35
    • 85172036247 scopus 로고    scopus 로고
    • RotaShield(R) [package insert]. Philadelphia PA: Wyeth Ayerst Laboratories
    • RotaShield(R) [package insert]. Philadelphia, PA: Wyeth Ayerst Laboratories, 1998.
    • (1998)
  • 36
    • 85172034912 scopus 로고    scopus 로고
    • U.S. Central Intelligence Agency. Ghana Accessed 8 May 2013
    • U.S. Central Intelligence Agency. Ghana. https://www.cia.gov/library/ publications/the-world-factbook/geos/gh.html. Accessed 8 May 2013.
  • 37
    • 85172038635 scopus 로고    scopus 로고
    • Ghana Statistical Service Ministry of Health (MOH) (Ghana) Macro International Inc. Ghana Demographic and Health Survey Accessed 8 May 2013
    • Ghana Statistical Service, Ministry of Health (MOH) (Ghana), Macro International Inc. Ghana Demographic and Health Survey, 2008. http://www.healthmetricsandevaluation.org/ghdx/record/ghana-demographic-and- health-survey-2008. Accessed 8 May 2013.
    • (2008)
  • 38
    • 0025258878 scopus 로고
    • Rotavirus disease in Finnish children: Use of numerical scores for clinical severity of diarrhoeal episodes
    • Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for clinical severity of diarrhoeal episodes. Scand J Infect Dis 1990; 22:259-67.
    • (1990) Scand J Infect Dis , vol.22 , pp. 259-267
    • Ruuska, T.1    Vesikari, T.2
  • 39
    • 0026686160 scopus 로고
    • Identification of group A rotavirus gene 4 types by polymerase chain reaction
    • Gentsch JR, Glass RI, Woods P, et al. Identification of group A rotavirus gene 4 types by polymerase chain reaction. J Clin Microbiol 1992; 30:1365-73.
    • (1992) J Clin Microbiol , vol.30 , pp. 1365-1373
    • Gentsch, J.R.1    Glass, R.I.2    Woods, P.3
  • 40
    • 0025166405 scopus 로고
    • Polymerase chain reaction amplification and typing of rotavirus nucleic acid from stool specimens
    • Gouvea V, Glass RI, Woods P, et al. Polymerase chain reaction amplification and typing of rotavirus nucleic acid from stool specimens. J Clin Microbiol 1990; 28:276-82.
    • (1990) J Clin Microbiol , vol.28 , pp. 276-282
    • Gouvea, V.1    Glass, R.I.2    Woods, P.3
  • 41
    • 0024538067 scopus 로고
    • Effects of antibody to rotavirus on protection of adults challenged with a human rotavirus
    • Ward RL, Bernstein DI, Shukla R, et al. Effects of antibody to rotavirus on protection of adults challenged with a human rotavirus. J Infect Dis 1989; 159:79-88.
    • (1989) J Infect Dis , vol.159 , pp. 79-88
    • Ward, R.L.1    Bernstein, D.I.2    Shukla, R.3
  • 42
    • 0026497985 scopus 로고
    • Safety and immunogenicity of oral tet-ravalent human-rhesus reassortant rotavirus vaccine in neonates
    • Dagan R, Kassis I, Sarov B, et al. Safety and immunogenicity of oral tet-ravalent human-rhesus reassortant rotavirus vaccine in neonates. Pediatr Infect Dis J 1992; 11:991-6.
    • (1992) Pediatr Infect Dis J , vol.11 , pp. 991-996
    • Dagan, R.1    Kassis, I.2    Sarov, B.3
  • 44
    • 0025201330 scopus 로고
    • Evaluation of RIT 4237 bovine rotavirus vaccine in newborn infants: Correlation of vaccine efficacy to season of birth in relation to rotavirus epidemic period
    • Ruuska T, Vesikari T, Delem A, Andre FE, Beards GM, Flewett TH. Evaluation of RIT 4237 bovine rotavirus vaccine in newborn infants: correlation of vaccine efficacy to season of birth in relation to rotavirus epidemic period. Scand J Infect Dis 1990; 22:269-78.
    • (1990) Scand J Infect Dis , vol.22 , pp. 269-278
    • Ruuska, T.1    Vesikari, T.2    Delem, A.3    Andre, F.E.4    Beards, G.M.5    Flewett, T.H.6
  • 45
    • 84891680734 scopus 로고    scopus 로고
    • Meeting of the Strategic Advisory Group of Experts on immunization, April 2012-conclusions and recommendations
    • Meeting of the Strategic Advisory Group of Experts on immunization, April 2012-conclusions and recommendations. Wkly Epidemiol Rec 2012; 87:201-16.
    • (2012) Wkly Epidemiol Rec , vol.87 , pp. 201-216
  • 46
    • 1642468774 scopus 로고    scopus 로고
    • Acute intussusception in infants and children-Incidence clinical presentation and management: S global perspective
    • Geneva: World Health Organization
    • Bines JE, Ivanoff B. Acute intussusception in infants and children-Incidence, clinical presentation and management: s global perspective. Vaccines and Biologicals. Geneva: World Health Organization, 2002: 98.
    • (2002) Vaccines and Biologicals , vol.98
    • Bines, J.E.1    Ivanoff, B.2
  • 48
    • 80052779166 scopus 로고    scopus 로고
    • Maintaining vaccine delivery following the introduction of the rotavirus and pneumococcal vaccines in Thailand
    • Lee BY, Assi TM, Rookkapan K, et al. Maintaining vaccine delivery following the introduction of the rotavirus and pneumococcal vaccines in Thailand. PLoS ONE [Electronic Resource]. 2011;6:e24673.
    • (2011) PLoS ONE [Electronic Resource]. , vol.6
    • Lee, B.Y.1    Assi, T.M.2    Rookkapan, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.