Evidence map›Paper›PMID 29466164›Full record

Trial reportThe New England journal of medicine2018

Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth.

Julie E Bines, Jarir At Thobari, Cahya Dewi Satria, Amanda Handley, Emma Watts, Daniel Cowley, Hera Nirwati, James Ackland, Jane Standish, Frances Justice and 12 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 8 pooled it
10.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 8 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
  2. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
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  7. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 7 institutions in 4 countries.

Julie E BinesFrom 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.).ORCID 0000-0002-5452-6601
Jarir At ThobariFrom 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.).
Cahya Dewi SatriaFrom 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.).
Amanda HandleyFrom 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.).
Emma WattsFrom 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.).
Daniel CowleyFrom 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.).
Hera NirwatiFrom 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.).
James AcklandFrom 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.).
Jane StandishFrom 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.).
Frances JusticeFrom 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.).
Gabrielle ByarsFrom 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.).
Katherine J LeeFrom 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.).
Graeme L BarnesFrom 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.).
Novilia S BachtiarFrom 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.).
Ajeng Viska IcanerviliaFrom 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.).
Karen BonifaceFrom 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.).
Nada Bogdanovic-SakranFrom 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.).
Daniel PavlicFrom 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.).
Ruth F BishopFrom 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.).
Carl D KirkwoodFrom 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.).
Jim P ButteryFrom 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.).
Yati SoenartoFrom 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.).
Jisc · GBMurdoch Children's Research Institute · AUThe University of Melbourne · AURoyal Children's Hospital · AUCenter for Global Development · USGates Foundation · USUniversitas Gadjah Mada · ID

Funding

Medical Research Council
6 · The paper itself

Abstract

backgroundA 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.

methodsWe 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.

resultsAmong 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.

conclusionsRV3-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 .).

Indexed as

Administration, OralDouble-Blind MethodFecesFemaleGastroenteritisHumansImmunization ScheduleIndonesiaInfantInfant, NewbornIntention to Treat AnalysisMaleRotavirusRotavirus InfectionsRotavirus VaccinesTreatment OutcomeRotavirus VaccinesRV3 rotavirus vaccine

Identifiers

PMID29466164
PMCPMC5774175
OpenAlexW2793865752

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