PMID- 29466164
OWN - NLM
STAT- MEDLINE
DCOM- 20180228
LR  - 20181113
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 378
IP  - 8
DP  - 2018 Feb 22
TI  - Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth.
PG  - 719-730
LID - 10.1056/NEJMoa1706804 [doi]
AB  - BACKGROUND: A strategy of administering a neonatal rotavirus vaccine at birth to 
      target early prevention of rotavirus gastroenteritis may address some of the
      barriers to global implementation of a rotavirus vaccine. METHODS: We conducted a
      randomized, double-blind, placebo-controlled trial in Indonesia to evaluate the
      efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing
      rotavirus gastroenteritis. Healthy newborns received three doses of RV3-BB,
      administered according to a neonatal schedule (0 to 5 days, 8 weeks, and 14 weeks
      of age) or an infant schedule (8 weeks, 14 weeks, and 18 weeks of age), or
      placebo. The primary analysis was conducted in the per-protocol population, which
      included only participants who received all four doses of vaccine or placebo
      within the visit windows, with secondary analyses performed in the
      intention-to-treat population, which included all participants who underwent
      randomization. RESULTS: Among the 1513 participants in the per-protocol
      population, severe rotavirus gastroenteritis occurred up to the age of 18 months 
      in 5.6% of the participants in the placebo group (28 of 504 babies), in 1.4% in
      the neonatal-schedule vaccine group (7 of 498), and in 2.7% in the
      infant-schedule vaccine group (14 of 511). This resulted in a vaccine efficacy of
      75% (95% confidence interval [CI], 44 to 91) in the neonatal-schedule group
      (P<0.001), 51% (95% CI, 7 to 76) in the infant-schedule group (P=0.03), and 63%
      (95% CI, 34 to 80) in the neonatal-schedule and infant-schedule groups combined
      (combined vaccine group) (P<0.001). Similar results were observed in the
      intention-to-treat analysis (1649 participants); the vaccine efficacy was 68%
      (95% CI, 35 to 86) in the neonatal-schedule group (P=0.001), 52% (95% CI, 11 to
      76) in the infant-schedule group (P=0.02), and 60% (95% CI, 31 to 76) in the
      combined vaccine group (P<0.001). Vaccine response, as evidenced by serum immune 
      response or shedding of RV3-BB in the stool, occurred in 78 of 83 participants
      (94%) in the neonatal-schedule group and in 83 of 84 participants (99%) in the
      infant-schedule group. The incidence of adverse events was similar across the
      groups. No episodes of intussusception occurred within the 21-day risk period
      after administration of any dose of vaccine or placebo, and one episode of
      intussusception occurred 114 days after the third dose of vaccine in the
      infant-schedule group. CONCLUSIONS: RV3-BB was efficacious in preventing severe
      rotavirus gastroenteritis when administered according to a neonatal or an infant 
      schedule in Indonesia. (Funded by the Bill and Melinda Gates Foundation and
      others; Australian New Zealand Clinical Trials Registry number,
      ACTRN12612001282875 .).
FAU - Bines, Julie E
AU  - Bines JE
AUID- ORCID: 0000-0002-5452-6601
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - At Thobari, Jarir
AU  - At Thobari J
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Satria, Cahya Dewi
AU  - Satria CD
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Handley, Amanda
AU  - Handley A
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Watts, Emma
AU  - Watts E
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Cowley, Daniel
AU  - Cowley D
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Nirwati, Hera
AU  - Nirwati H
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Ackland, James
AU  - Ackland J
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Standish, Jane
AU  - Standish J
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Justice, Frances
AU  - Justice F
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Byars, Gabrielle
AU  - Byars G
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Lee, Katherine J
AU  - Lee KJ
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Barnes, Graeme L
AU  - Barnes GL
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Bachtiar, Novilia S
AU  - Bachtiar NS
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Viska Icanervilia, Ajeng
AU  - Viska Icanervilia A
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Boniface, Karen
AU  - Boniface K
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Bogdanovic-Sakran, Nada
AU  - Bogdanovic-Sakran N
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Pavlic, Daniel
AU  - Pavlic D
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Bishop, Ruth F
AU  - Bishop RF
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Kirkwood, Carl D
AU  - Kirkwood CD
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Buttery, Jim P
AU  - Buttery JP
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
FAU - Soenarto, Yati
AU  - Soenarto Y
AD  - From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute
      (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P.,
      R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne
      (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of
      Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne
      (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and
      Preventive Medicine, Monash University, and the Department of Infection and
      Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development
      for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in
      Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the
      Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and 
      the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah
      Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the 
      Bill and Melinda Gates Foundation, Seattle (C.D.K.).
LA  - eng
SI  - ANZCTR/ACTRN12612001282875
GR  - Medical Research Council/United Kingdom
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (RV3 rotavirus vaccine)
RN  - 0 (Rotavirus Vaccines)
SB  - AIM
SB  - IM
MH  - Administration, Oral
MH  - Double-Blind Method
MH  - Feces/virology
MH  - Female
MH  - Gastroenteritis/epidemiology/*prevention & control/virology
MH  - Humans
MH  - Immunization Schedule
MH  - Indonesia
MH  - Infant
MH  - Infant, Newborn
MH  - Intention to Treat Analysis
MH  - Male
MH  - Rotavirus/isolation & purification
MH  - Rotavirus Infections/*prevention & control
MH  - Rotavirus Vaccines/administration & dosage/adverse effects/*immunology
MH  - Treatment Outcome
PMC - PMC5774175
EDAT- 2018/02/22 06:00
MHDA- 2018/03/01 06:00
CRDT- 2018/02/22 06:00
PHST- 2018/02/22 06:00 [entrez]
PHST- 2018/02/22 06:00 [pubmed]
PHST- 2018/03/01 06:00 [medline]
AID - 10.1056/NEJMoa1706804 [doi]
PST - ppublish
SO  - N Engl J Med. 2018 Feb 22;378(8):719-730. doi: 10.1056/NEJMoa1706804.