Evidence map›Paper›PMID 30074540›Full record

Trial reportEpidemiology (Cambridge, Mass.)2018

Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries.

Joann F Gruber, Sylvia Becker-Dreps, Michael G Hudgens, M Alan Brookhart, James C Thomas, Michele Jonsson Funk

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Epidemiology (Cambridge, Mass.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 38% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. 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 at 1 institution in 1 country.

Joann F GruberDepartment of Epidemiology, University of North Carolina (UNC)-Chapel Hill, Chapel Hill, NC.
Sylvia Becker-DrepsDepartment of Epidemiology, University of North Carolina (UNC)-Chapel Hill, Chapel Hill, NC.
Michael G HudgensDepartment of Biostatistics, UNC-Chapel Hill, Chapel Hill, NC.
M Alan BrookhartDepartment of Epidemiology, University of North Carolina (UNC)-Chapel Hill, Chapel Hill, NC.
James C ThomasDepartment of Epidemiology, University of North Carolina (UNC)-Chapel Hill, Chapel Hill, NC.
Michele Jonsson FunkDepartment of Epidemiology, University of North Carolina (UNC)-Chapel Hill, Chapel Hill, NC.
University of North Carolina at Chapel Hill · US

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

backgroundAltering rotavirus vaccine schedules may improve vaccine performance in low- and middle-income countries. We analyzed data from clinical trials of the monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in low- and middle-income countries to understand the association between vaccine dose timing and severe rotavirus gastroenteritis incidence.

methodsWe assessed the association between variations in rotavirus vaccine administration schedules and severe rotavirus gastroenteritis risk. We used the complement of the Kaplan-Meier survival estimator to estimate risk differences for different schedules. To adjust risk differences (RDs) for confounding, we calibrated estimates in the vaccinated arm using estimates from the placebo arm.

resultsThere were 3,114 and 7,341 children included from the RV1 and RV5 trials, respectively. The 18-month adjusted severe rotavirus gastroenteritis risk was 4.0% (95% confidence interval [CI] = 1.1, 7.1) higher for those receiving their first RV5 dose at <6 versus ≥6 weeks. For RV1, there was a 4.0% (95% CI = 0.0, 8.2) increase in 12-month adjusted risk for a 4- versus 6-week interval between doses. Further analysis revealed those receiving their first RV5 dose at 3-4 and 5-7 weeks had 2.9% (95% CI = 0.8, 5.3) and 1.3% (95% CI = -0.3, 3.0), respectively, higher risk compared with those at 9-12 weeks. Those receiving their first dose at 8 weeks had the lowest risk (RD: -2.6% [95% CI = -5.4, -0.1]) compared with those at 9-12 weeks.

conclusionsA modest delay in rotavirus vaccination start and increase in interval between doses may be associated with lower severe rotavirus gastroenteritis risk in low- and middle-income countries.

Indexed as

Developing CountriesFemaleGastroenteritisHumansImmunization ScheduleIncidenceInfantKaplan-Meier EstimateMalawiMaleRisk FactorsRotavirus InfectionsRotavirus VaccinesSouth AfricaTime FactorsVaccines, AttenuatedRIX4414 vaccineRotaTeqRotavirus VaccinesVaccines, Attenuated

Identifiers

PMID30074540
PMCPMC6167161
OpenAlexW2885381055

What OpenQuestion holds

Textmetadata
LicenceTDM
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.