Evidence map›Paper›PMID 29564996›Full record

Trial reportEpidemiology and infection2018

Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries.

J F Gruber, S Becker-Dreps, M G Hudgens, M A Brookhart, J C Thomas, M Jonsson Funk

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Epidemiology and infection, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT00241644 phase3completednot on this map

Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants

TypeinterventionalSponsorGlaxoSmithKlineRan2005 to 2008Enrolled2,089ConditionsInfections, RotavirusArmsRotarix™, Placebo
NCT00362648 phase3completednot on this map

Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2009Enrolled7,504ConditionsVomiting, Diarrhea, FeverArmsRotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

6 authors.

J F GruberDepartment of Epidemiology,Gillings School of Global Public Health, UNC-Chapel Hill,Chapel Hill, North Carolina,USA.
S Becker-DrepsDepartment of Family Medicine,UNC-Chapel Hill,Chapel Hill, North Carolina,USA.
M G HudgensDepartment of Biostatistics,Gillings School of Global Public Health, UNC-Chapel Hill,Chapel Hill, North Carolina,USA.
M A BrookhartDepartment of Epidemiology,Gillings School of Global Public Health, UNC-Chapel Hill,Chapel Hill, North Carolina,USA.
J C ThomasDepartment of Epidemiology,Gillings School of Global Public Health, UNC-Chapel Hill,Chapel Hill, North Carolina,USA.
M Jonsson FunkDepartment of Epidemiology,Gillings School of Global Public Health, UNC-Chapel Hill,Chapel Hill, North Carolina,USA.

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Research Services CoreP2CHD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KAREN B GUZZO · 2015 to 2026
$9.6M
Propensity Scores and Preventive Drug Use in the ElderlyR01AG023178 · NIA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI STURMER, TIL · 2005 to 2014
$2.7M
Methods for Estimating Sex Differences in Safety and Effectiveness of DrugsR01HL118255 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JONSSON FUNK, MICHELE LAURA · 2014 to 2017
$1.7M
Simple interventions to Improve Rotavirus Vaccine Effectiveness (SIRVE)R56AI108515 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BECKER-DREPS, SYLVIA IRENE · 2014 to 2014
$478k
Patterns of use, comparative effectiveness, and safety of rotavirus vaccinesR21HD080214 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BROOKHART, MAURICE ALAN · 2014 to 2015
$413k
NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NHLBI NIH HHS R01 HL118255NIAID NIH HHS R56 AI108515NIA NIH HHS R01 AG023178NICHD NIH HHS P2C HD050924NICHD NIH HHS R21 HD080214
6 · The paper itself

Abstract

Delays in rotavirus vaccine schedule could improve performance in low- and middle-income countries (LMICs). However, delaying the first dose could be detrimental if infants experience severe rotavirus gastroenteritis (RVGE) early in life. Our objective was to describe the timing and predictors of severe RVGE in unvaccinated children in LMICs. We analysed the placebo arms from two clinical trials (cohort 1: NCT00241644; cohort 2: NCT00362648). We estimated the rate, cumulative incidence (per 1000 infants) and age distribution of severe RVGE episodes. Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals (CI) for the association between baseline factors and severe RVGE. Cumulative incidence at 6 months of age was 23/1000 (95% CI 15-30) in cohort 1 and 6/1000 (95% CI 3-8) in cohort 2. Early antibiotic use (compared with no use) was associated with 2.03 (95% CI 1.18-3.48) and 1.41 (95% CI 0.80-2.51) times the rate of severe RVGE in cohorts 1 and 2, respectively. The cumulative incidence of severe RVGE was low at 6 months of age, suggesting that a 4-week delay in the vaccination schedule may not result in a large number of severe RVGE episodes prior to vaccine receipt.

Indexed as

Developing CountriesAge FactorsChild, PreschoolClinical Trials as TopicFemaleGastroenteritisHumansIncidenceInfantMaleRisk AssessmentRisk FactorsRotavirus InfectionsRotavirus VaccinesRotavirus VaccinesEpidemiologygastroenteritisimmunisation (vaccination)rotavirus

Identifiers

PMID29564996
PMCPMC5895523

What OpenQuestion holds

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Registered trials

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.