Evidence map›Paper›PMID 31607604›Full record

Trial reportVaccine2019

Immunogenicity of four doses of oral poliovirus vaccine when co-administered with the human neonatal rotavirus vaccine (RV3-BB).

Daniel Cowley, Rini Mulia Sari, Amanda Handley, Emma Watts, Novilia S Bachtiar, Jarir At Thobari, Cahya Dewi Satria, Nada Bogdanovic-Sakran, Hera Nirwati, Francesca Orsini and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 3 countries.

Daniel CowleyEnteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
Rini Mulia SariBio Farma PT, Bandung, Indonesia.
Amanda HandleyEnteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Medicines Development for Global Health, Melbourne, Victoria, Australia.
Emma WattsEnteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Novilia S BachtiarBio Farma PT, Bandung, Indonesia.
Jarir At ThobariDepartments of Pharmacology and Therapy, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia; Paediatric Research Office, Department of Paediatrics Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Cahya Dewi SatriaPaediatric Research Office, Department of Paediatrics Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Nada Bogdanovic-SakranEnteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Hera NirwatiDepartments of Microbiology, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Francesca OrsiniClinical Epidemiology and Biostatistics Unit and the Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Katherine J LeeDepartment of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Clinical Epidemiology and Biostatistics Unit and the Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Carl D KirkwoodEnteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Bill and Melinda Gates Foundation, Seattle, WA, USA.
Yati SoenartoPaediatric Research Office, Department of Paediatrics Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Julie E BinesEnteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Parkville, Victoria, Australia. Electronic address: jebines@unimelb.edu.au.
Universitas Gadjah Mada · IDMurdoch Children's Research Institute · AUPT Bio Farma (Indonesia) · IDThe University of Melbourne · AUCenter for Global Development · USGates Foundation · USRoyal Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe RV3-BB human neonatal rotavirus vaccine was developed to provide protection from severe rotavirus disease from birth. The aim of this study was to investigate the potential for mutual interference in the immunogenicity of oral polio vaccine (OPV) and RV3-BB.

methodsA randomized, placebo-controlled trial involving 1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia. Participants received three doses of oral RV3-BB, with the first dose given at 0-5 days (neonatal schedule) or ~8 weeks (infant schedule), or placebo. Two sub-studies assessed the immunogenicity of RV3-BB when co-administered with either trivalent OPV (OPV group, n = 282) or inactivated polio vaccine (IPV group, n = 333). Serum samples were tested for antibodies to poliovirus strains 1, 2 and 3 by neutralization assays following doses 1 and 4 of OPV.

resultsSero-protective rates to poliovirus type 1, 2 or 3 were similar (range 0.96-1.00) after four doses of OPV co-administered with RV3-BB compared with placebo. Serum IgA responses to RV3-BB were similar when co-administered with either OPV or IPV (difference in proportions OPV vs IPV: sIgA responses; neonatal schedule 0.01, 95% CI -0.12 to 0.14; p = 0.847; infant schedule -0.10, 95% CI -0.21 to -0.001; p = 0.046: sIgA GMT ratio: neonatal schedule 1.23, 95% CI 0.71-2.14, p = 0.463 or infant schedule 1.20, 95% CI 0.74-1.96, p = 0.448).

conclusionsThe co-administration of OPV with RV3-BB rotavirus vaccine in a birth dose strategy did not reduce the immunogenicity of either vaccine. These findings support the use of a neonatal RV3-BB vaccine where either OPV or IPV is used in the routine vaccination schedule.

Indexed as

Antibodies, ViralFemaleHumansImmunization ScheduleImmunogenicity, VaccineImmunoglobulin AInfantInfant, NewbornMalePoliomyelitisPoliovirusPoliovirus Vaccine, InactivatedPoliovirus Vaccine, OralRotavirusRotavirus InfectionsRotavirus VaccinesAntibodies, ViralImmunoglobulin APoliovirus Vaccine, InactivatedPoliovirus Vaccine, OralRotavirus VaccinesRV3 rotavirus vaccineNeonatalPoliovirusRotavirusVaccine

Identifiers

PMID31607604
PMCPMC6880301
OpenAlexW2980244223

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.