Molecular characterization of rotavirus strains from children with Diarrhea in Italy 2007-2009

Journal of Medical Virology

Volumn 83, Issue 9, 2011, Pages 1657-1668

  Ruggeri, Franco Maria ^a   Delogu, Roberto ^a   Petouchoff, Tatiana ^a   Tcheremenskaia, Olga ^a   De Petris, Simona ^a   Fiore, Lucia ^a   Pompa, Maria Grazia ^b   Russo, Francesca ^c   Zanella, Francesca ^c   Cesco, Dario ^d   Sartore, Paola ^e   Micera, Monica ^f   Zotti, Carla ^g   Cacello, Elena ^g   Balbi, Luciano ^g   Barbi, Maria ^h   Binda, Sandro ^h   Primache, Valeria ^h   Iorio, Anna Maria ⁱ   Camilloni, Barbara ⁱ   Basileo, Michela ⁱ   Medici, Maria Cristina ^j   Chezzi, Carlo ^j   Abelli, Laura ^j   Rizzo, Caterina ^a   Giammanco, Giovanni Maurizio ^k   De Grazia, Simona ^k   Platia, Maria Angela ^k   Chironna, Maria ^l   Sallustio, Anna ^l   Germinario, Cinzia ^l   Tanzi, Maria Luisa ^j   Pietrosemoli, Paola ^m   D’Errico, Marcello ⁿ   Marigliano, Anna ⁿ   Comodo, Nicola ^o   Lorini, Chiara ^o   Martella, Vito ^l   Storelli, Sonia ^p   Cocchi, Priscilla ^q   Festini, Filippo ^o   De Rosa, Marta ^r   Chisari, Mattia ^r   Raglio, Annibale ^s   Zanchi, Alessandra ^t   Onori, Manuela ^u   Danzi, Gaetano ^v   Lazzarotto, Tiziana ^w   Pedroni, Mino ^x   Mignacca, Anna ^y   Ansaldi, Filippo ^z   Mammì, Pierdomenico ^aa   more..

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b MINISTRY OF HEALTH   (Italy)

^c Regione Veneto Servizio Promozione e Sviluppo Igiene e Sanità Pubblica   (Italy)

^d Laboratorio di Microbiologia   (Italy)

^e Ospedale di Camposampiero (PD)   (Italy)

^f SAN MARTINO HOSPITAL   (Italy)

^g UNIVERSITY OF TURIN   (Italy)

^h UNIVERSITY OF MILAN   (Italy)

ⁱ UNIVERSITY OF PERUGIA   (Italy)

^j UNIVERSITY OF PARMA   (Italy)

^k UNIVERSITY OF PALERMO   (Italy)

^l UNIVERSITY OF BARI   (Italy)

^m UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

ⁿ UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^o UNIVERSITY OF FLORENCE   (Italy)

^p PO di Bisceglie   (Italy)

^q UNIVERSITY OF FLORENCE   (Italy)

^r Azienda Ospedaliera   (Italy)

^s OSPEDALI RIUNITI   (Italy)

^t UNIVERSITY OF SIENA   (Italy)

^u BAMBINO GESÙ CHILDREN S HOSPITAL   (Italy)

^v San Giuseppe Moscati Hospital   (Italy)

^w UNIVERSITY OF BOLOGNA   (Italy)

^x Presidio Ospedaliera di Manerbio   (Italy)

^y MAGGIORE HOSPITAL   (Italy)

^z UNIVERSITY OF GENOA   (Italy)

^aa NONE   (Italy)

more..

Author keywords

Gene reassortment; Genotyping; Molecular epidemiology; Rotavirus; Zoonotic transmission

Indexed keywords

VIRUS DNA;

ARTICLE; CHILD; CHILDHOOD DISEASE; DNA SEQUENCE; GENETIC REASSORTMENT; GENOTYPE; HUMAN; INFECTIOUS DIARRHEA; ITALY; MAJOR CLINICAL STUDY; MIXED INFECTION; NONHUMAN; PRESCHOOL CHILD; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; ROTAVIRUS; ROTAVIRUS INFECTION; VIRUS GENE; VIRUS STRAIN;

ANIMALIA; ROTAVIRUS;

EID: 79960146343     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.22163     Document Type: Article

References (71)

1. Anderson EJ. 2008. Rotavirus vaccines: Viral shedding and risk of transmission. Lancet Infect Dis 8:642-649.
2. Arista S, Giammanco GM, De Grazia S, Colomba C, Martella V, Cascio A, Iturriza-Gomara M. 2005. G2 rotavirus infections in an infantile population of the South of Italy: Variability of viral strains over time. J Med Virol 77:587-594.
3. Banyai K, Esona MD, Mijatovic S, Kerin TK, Pedreira C, Mercado J, Balmaseda A, Perez MC, Patel MM, Gentsch JR. 2009a. Zoonotic bovine rotavirus strain in a diarrheic child, Nicaragua. J Clin Virol 46:391-393.
4. Banyai K, Martella V, Molnar P, Mihaly I, Van Ranst M, Matthijnssens J. 2009b. Genetic heterogeneity in human G6P[14] rotavirus strains detected in Hungary suggests independent zoonotic origin. J Infect 59:213-215.
5. Banyai K, Papp H, Dandar E, Molnar P, Mihaly I, Van Ranst M, Martella V, Matthijnssens J. 2010. Whole genome sequencing and phylogenetic analysis of a zoonotic human G8P[14] rotavirus strain. Infect Genet Evol 10:1140-1144.
6. Blutt SE, Matson DO, Crawford SE, Staat MA, Azimi P, Bennett BL, Piedra PA, Conner ME. 2007. Rotavirus antigenemia in children is associated with viremia. PLoS Med 4:e121.
7. Boom JA, Tate JE, Sahni LC, Rench MA, Hull JJ, Gentsch JR, Patel MM, Baker CJ, Parashar UD. 2010. Effectiveness of pentavalent rotavirus vaccine in a large urban population in the United States. Pediatrics 125:e199-e207.
8. Ciarlet M, Hoshino Y, Liprandi F. 1997. Single point mutations may affect the serotype reactivity of serotype G11 porcine rotavirus strains: A widening spectrum? J Virol 71:8213-8220.
9. Clark HF, Offit PA, Plotkin SA, Heaton PM. 2006. The new pentavalent rotavirus vaccine composed of bovine (strain WC3)-human rotavirus reassortants. Pediatr Infect Dis J 25:577-583.
10. Clark HF, Lawley D, Mallette LA, DiNubile MJ, Hodinka RL. 2009. Decline in cases of rotavirus gastroenteritis presenting to The Children’s Hospital of Philadelphia after introduction of a pentavalent rotavirus vaccine. Clin Vaccine Immunol 16:382-386.
11. Coffin SE, Moser CA, Cohen S, Clark HF, Offit PA. 1997. Immunologic correlates of protection against rotavirus challenge after intramuscular immunization of mice. J Virol 71:7851-7856.
12. Collins PJ, Martella V, Buonavoglia C, O’Shea H. 2010. Identification of a G2-like porcine rotavirus bearing a novel VP4 type, P[32]. Vet Res 41:73.
13. de Oliveira LH, Danovaro-Holliday MC, Matus CR, Andrus JK. 2008. Rotavirus vaccine introduction in the Americas: Progress and lessons learned. Expert Rev Vaccines 7:345-353.
14. de Rougemont A, Kaplon J, Pillet S, Mory O, Gagneur A, Minoui- Tran A, Meritet JF, Mollat C, Lorrot M, Foulongne V, Gillet Y, Nguyen-Bourgain C, Alain S, Agius G, Lazrek M, Colimon R, Fontana C, Gendrel D, Pothier P. 2011. Molecular and clinical characterization of rotavirus from diarrheal infants admitted to pediatric emergency units in france. Pediatr Infect Dis J 30:118-124.
15. Desselberger U, Huppertz HI. 2011. Immune responses to rotavirus infection and vaccination and associated correlates of protection. J Infect Dis 203:188-195.
16. Desselberger U, Wolleswinkel-van den Bosch J, Mrukowicz J, Rodrigo C, Giaquinto C, Vesikari T. 2006. Rotavirus types in Europe and their significance for vaccination. Pediatr Infect Dis J 25:S30-S41.
17. Desselberger U, Manktelow E, Li W, Cheung W, Iturriza-Gomara M, Gray J. 2009. Rotaviruses and rotavirus vaccines. Br Med Bull 90:37-51.
18. Esona MD, Geyer A, Page N, Trabelsi A, Fodha I, Aminu M, Agbaya VA, Tsion B, Kerin TK, Armah GE, Steele AD, Glass RI, Gentsch JR. 2009. Genomic characterization of human rotavirus G8 strains from the African rotavirus network: Relationship to animal rotaviruses. J Med Virol 81:937-951.
19. Estes MK, Kapikian AZ. 2007. Rotaviruses. In: Knipe DM, Howley PM, Griffin DE, Lamb RA, Martin MA, Roizman B, Straus SE, editors. Fields virology. 5th editon. Philadelphia: Lippincott Williams & Wilkins, pp 1917-1974.
20. Feng N, Sen A, Wolf M, Vo P, Hoshino Y, Greenberg HB. 2011. Roles of VP4 and NSP1 in determining the distinctive replication capacities of simian rotavirus RRV and bovine rotavirus UK in the mouse biliary tract. J Virol 85:2686-2694.
21. Forster J, Guarino A, Parez N, Moraga F, Roman E, Mory O, Tozzi AE, de Aguileta AL, Wahn U, Graham C, Berner R, Ninan T, Barberousse C, Meyer N, Soriano-Gabarro M. 2009. Hospitalbased surveillance to estimate the burden of rotavirus gastroenteritis among European children younger than 5 years of age. Pediatrics 123:e393-e400.
22. Gentsch JR, Glass RI, Woods P, Gouvea V, Gorziglia M, Flores J, Das BK, Bhan MK. 1992. Identification of group A rotavirus gene 4 types by polymerase chain reaction. J Clin Microbiol 30:1365-1373.
23. Gentsch JR, Laird AR, Bielfelt B, Griffin DD, Banyai K, Ramachandran M, Jain V, Cunliffe NA, Nakagomi O, Kirkwood CD, Fischer TK, Parashar UD, Bresee JS, Jiang B, Glass RI. 2005. Serotype diversity and reassortment between human and animal rotavirus strains: Implications for rotavirus vaccine programs. J Infect Dis 192:S146-S159.
24. Giaquinto C, van Damme P, REVEAL Study Group. 2010. Age distribution of paediatric rotavirus gastroenteritis cases in Europe: The REVEAL study. Scand J Infect Dis 42:142-147.
25. Gombold JL, Ramig RF. 1986. Analysis of reassortment of genome segments in mice mixedly infected with rotaviruses SA11 and RRV. J Virol 57:110-116.
26. Gorrell RJ, Bishop RF. 1999. Homotypic and heterotypic serum neutralizing antibody response to rotavirus proteins following natural primary infection and reinfection in children. J Med Virol 57:204-211.
27. Gouvea V, Glass RI, Woods P, Taniguchi K, Clark HF, Forrester B, Fang ZY. 1990. Polymerase chain reaction amplification and typing of rotavirus nucleic acid from stool specimens. J Clin Microbiol 28:276-282.
28. Iturriza-Gomara M, Isherwood B, Desselberger U, Gray J. 2001. Reassortment in vivo: Driving force for diversity of human rotavirus strains isolated in the United Kingdom between 1995 and 1999. J Virol 75:3696-3705.
29. Iturriza-Gomara M, Kang G, Gray J. 2004. Rotavirus genotyping: Keeping up with an evolving population of human rotaviruses. J Clin Virol 31:259-265.
30. Iturriza-Gomara M, Dallman T, Banyai K, Bottiger B, Buesa J, Diedrich S, Fiore L, Johansen K, Korsun N, Kroneman A, Lappalainen M, Laszlo B, Maunula L, Matthinjnssens J, Midgley S, Mladenova Z, Poljsak-Prijatelj M, Pothier P, Ruggeri FM, Sanchez- Fauquier A, Schreier E, Steyer A, Sidaraviciute I, Tran AN, Usonis V, Van Ranst M, de Rougemont A, Gray J. 2009. Rotavirus surveillance in europe, 2005-2008: Web-enabled reporting and real-time analysis of genotyping and epidemiological data. J Infect Dis 200:S215-S221.
31. Iturriza-Gomara M, Dallman T, Banyai K, Bottiger B, Buesa J, Diedrich S, Fiore L, Johansen K, Koopmans M, Korsun N, Koukou D, Kroneman A, Laszlo B, Lappalainen M, Maunula L, Marques AM, Matthijnssens J, Midgley S, Mladenova Z, Nawaz S, Poljsak- Prijatelj M, Pothier P, Ruggeri FM, Sanchez-Fauquier A, Steyer A, Sidaraviciute-Ivaskeviciene I, Syriopoulou V, Tran AN, Usonis V, van Ranst M, de Rougemont A, Gray J. 2010. Rotavirus genotypes co-circulating in Europe between 2006 and 2009 as determined by EuroRotaNet, a pan-European collaborative strain surveillance network. Epidemiol Infect 139:895-909.
32. Jayaram H, Estes MK, Prasad BV. 2004. Emerging themes in rotavirus cell entry, genome organization, transcription and replication. Virus Res 101:67-81.
33. Martella V, Banyai K, Matthijnssens J, Buonavoglia C, Ciarlet M. 2010. Zoonotic aspects of rotaviruses. Vet Microbiol 140:246-255.
34. Martinez-Laso J, Roman A, Head J, Cervera I, Rodriguez M, Rodriguez- Avial I, Picazo JJ. 2009. Phylogeny of G9 rotavirus genotype: A possible explanation of its origin and evolution. J Clin Virol 44:52-57.
35. Matthijnssens J, Ciarlet M, Heiman E, Arijs I, Delbeke T, McDonald SM, Palombo EA, Iturriza-Gomara M, Maes P, Patton JT, Rahman M, Van Ranst M. 2008a. Full genome-based classification of rotaviruses reveals a common origin between human Wa-Like and porcine rotavirus strains and human DS-1-like and bovine rotavirus strains. J Virol 82:3204-3219.
36. Matthijnssens J, Ciarlet M, Rahman M, Attoui H, Banyai K, Estes MK, Gentsch JR, Iturriza-Gomara M, Kirkwood CD, Martella V, Mertens PP, Nakagomi O, Patton JT, Ruggeri FM, Saif LJ, Santos N, Steyer A, Taniguchi K, Desselberger U, Van Ranst M. 2008b. Recommendations for the classification of group A rotaviruses using all 11 genomic RNA segments. Arch Virol 153:1621-1629.
37. Maunula L, Von Bonsdorff CH. 2002. Frequent reassortments may explain the genetic heterogeneity of rotaviruses: Analysis of Finnish rotavirus strains. J Virol 76:11793-11800.
38. Medici MC, Martinelli M, Abelli LA, Ruggeri FM, Di Bartolo I, Arcangeletti MC, Pinardi F, De Conto F, Izzi G, Bernasconi S, Chezzi C, Dettori G. 2006. Molecular epidemiology of norovirus infections in sporadic cases of viral gastroenteritis among children in Northern Italy. J Med Virol 78:1486-1492.
39. Muhsen K, Shulman L, Rubinstein U, Kasem E, Kremer A, Goren S, Zilberstein I, Chodick G, Ephros M, Cohen D. 2009. Incidence, characteristics, and economic burden of rotavirus gastroenteritis associated with hospitalization of israeli children <5 years of age, 2007-2008. J Infect Dis 200:S254-S263.
40. Mukherjee A, Chattopadhyay S, Bagchi P, Dutta D, Singh NB, Arora R, Parashar UD, Gentsch JR, Chawla-Sarkar M. 2010. Surveillance and molecular characterization of rotavirus strains circulating in Manipur, north-eastern India: Increasing prevalence of emerging G12 strains. Infect Genet Evol 10:311-320.
41. Offit PA, Blavat G. 1986. Identification of the two rotavirus genes determining neutralization specificities. J Virol 57:376-378.
42. Parashar UD, Alexander JP, Glass RI. 2006. Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 55:1-13.
43. Parra GI, Espinola EE. 2006. Nucleotide mismatches between the VP7 gene and the primer are associated with genotyping failure of a specific lineage from G1 rotavirus strains. Virol J 3:35.
44. Perez-Schael I, Salinas B, Tomat M, Linhares AC, Guerrero ML, Ruiz-Palacios GM, Bouckenooghe A, Yarzabal JP. 2007. Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J Infect Dis 196:537-540.
45. Pesavento JB, Crawford SE, Estes MK, Prasad BV. 2006. Rotavirus proteins: Structure and assembly. Curr Top Microbiol Immunol 309:189-219.
46. 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. 2009. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study. Vaccine 27: 5936-5941.
47. Ruggeri FM, Declich S. 1999. Rotavirus infection among children with diarrhoea in Italy. Acta Paediatr Suppl 88:66-71.
48. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega- Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O’Ryan M. 2006. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 354:11-22.
49. Santos N, Hoshino Y. 2005. Global distribution of rotavirus serotypes/ genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol 15:29-56.
50. Santos N, Volotao EM, Soares CC, Albuquerque MC, da Silva FM, Chizhikov V, Hoshino Y. 2003. VP7 gene polymorphism of serotype G9 rotavirus strains and its impact on G genotype determination by PCR. Virus Res 93:127-138.
51. Shaw RD, Mackow ER, Dyall-Smith ML, Lazdins I, Holmes IH, Greenberg HB. 1988. Serotypic analysis of VP3 and VP7 neutralization escape mutants of rhesus rotavirus. J Virol 62:3509-3512.
52. Simmonds MK, Armah G, Asmah R, Banerjee I, Damanka S, Esona M, Gentsch JR, Gray JJ, Kirkwood C, Page N, Iturriza-Gomara M. 2008. New oligonucleotide primers for P-typing of rotavirus strains: Strategies for typing previously untypeable strains. J Clin Virol 42:368-373.
53. Solberg OD, Hasing ME, Trueba G, Eisenberg JN. 2009. Characterization of novel VP7, VP4, and VP6 genotypes of a previously untypeable group A rotavirus. Virology 385:58-67.
54. Song XF, Hao Y. 2009. Adaptive evolution of rotavirus VP7 and NSP4 genes in different species. Comput Biol Chem 33:344-349.
55. Soriano-Gabarro M, Mrukowicz J, Vesikari T, Verstraeten T. 2006. Burden of rotavirus disease in European Union countries. Pediatr Infect Dis J 25:S7-S11.
56. Steyer A, Poljsak-Prijatelj M, Barlic-Maganja D, Marin J. 2008. Human, porcine and bovine rotaviruses in Slovenia: Evidence of interspecies transmission and genome reassortment. J Gen Virol 89:1690-1698.
57. Steyer A, Bajzelj M, Iturriza-Gomara M, Mladenova Z, Korsun N, Poljsak-Prijatelj M. 2010. Molecular analysis of human group A rotavirus G10P[14] genotype in Slovenia. J Clin Virol 49:121-125.
58. To TL, Ward LA, Yuan L, Saif LJ. 1998. Serum and intestinal isotype antibody responses and correlates of protective immunity to human rotavirus in a gnotobiotic pig model of disease. J Gen Virol 79:2661-2672.
59. Trojnar E, Otto P, Johne R. 2009. The first complete genome sequence of a chicken group A rotavirus indicates independent evolution of mammalian and avian strains. Virology 386:325-333.
60. Turcios RM, Curns AT, Holman RC, Pandya-Smith I, LaMonte A, Bresee JS, Glass RI. 2006. Temporal and geographic trends of rotavirus activity in the United States, 1997-2004. Pediatr Infect Dis J 25:451-454.
61. Ursu K, Kisfali P, Rigo D, Ivanics E, Erdelyi K, Dan A, Melegh B, Martella V, Banyai K. 2009. Molecular analysis of the VP7 gene of pheasant rotaviruses identifies a new genotype, designated G23. Arch Virol 154:1365-1369.
62. Vesikari T, Clark HF, Offit PA, Dallas MJ, DiStefano DJ, Goveia MG, Ward RL, Schodel F, Karvonen A, Drummond JE, DiNubile MJ, Heaton PM. 2006a. Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine 24:4821-4829.
63. Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O’Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM. 2006b. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 354:23-33.
64. Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. 2007. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: Randomised, double-blind controlled study. Lancet 370:1757-1763.
65. Vesikari T, Itzler R, Karvonen A, Korhonen T, Van Damme P, Behre U, Bona G, Gothefors L, Heaton PM, Dallas M, Goveia MG. 2009. RotaTeq, a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe. Vaccine 28:345-351.
66. Ward RL, Jin Q, Nakagomi O, Sander DS, Gentsch JR. 1996. Isolation of a human rotavirus containing a bovine rotavirus VP4 gene that suppresses replication of other rotaviruses in coinfected cells. Arch Virol 141:615-633.
67. Watanabe M, Nakagomi T, Koshimura Y, Nakagomi O. 2001. Direct evidence for genome segment reassortment between concurrently-circulating human rotavirus strains. Arch Virol 146:557-570.
68. World Health Organization. 2007. Rotavirus vaccines. WHO position paper. Wkly Epidemiol Rec 82:285-295.
69. Yuan L, Azevedo MS, Gonzalez AM, Jeong KI, Van Nguyen T, Lewis P, Iosef C, Herrmann JE, Saif LJ. 2005. Mucosal and systemic antibody responses and protection induced by a prime/boost rotavirus- DNA vaccine in a gnotobiotic pig model. Vaccine 23:3925-3936.
70. Yuan L, Honma S, Kim I, Kapikian AZ, Hoshino Y. 2009. Resistance to rotavirus infection in adult volunteers challenged with a virulent G1P1A[8] virus correlated with serum immunoglobulin G antibodies to homotypic viral proteins 7 and 4. J Infect Dis 200:1443-1451.
71. Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. 2010. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: A randomised, double-blind, placebo-controlled trial. Lancet 376:615-623.