Evidence map›Paper›PMID 37286215›Full record

Trial reportBMJ (Clinical research ed.)2023

Measles, mumps, and rubella vaccine at age 6 months and hospitalisation for infection before age 12 months: randomised controlled trial.

Anne Cathrine Zimakoff, Andreas Jensen, Dorthe Maria Vittrup, Emma Hoppe Herlufsen, Jesper Kiehn Sørensen, Michelle Malon, Jannet Svensson, Lone Graff Stensballe

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03780179 (Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting), which is not on this 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
1.2field-weighted citation impact, top 21% 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.

NCT03780179 phase4completednot on this map

Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting

TypeinterventionalSponsorRigshospitalet, DenmarkRan2019 to 2022Enrolled6,540ConditionsMeales-mumps-rubella VaccineArmsMMRvaxpro, Placebo
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. Article
  3. Review
  4. 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

8 authors at 3 institutions in 1 country.

Anne Cathrine ZimakoffDepartment of Paediatrics and Adolescent Medicine, Danish National University Hospital "Rigshospitalet," Copenhagen, Denmark anne.cathrine.zimakoff@regionh.dk.ORCID 0000-0001-9872-6608
Andreas JensenDepartment of Paediatrics and Adolescent Medicine, Danish National University Hospital "Rigshospitalet," Copenhagen, Denmark.
Dorthe Maria VittrupChild and Adolescent Department, University Hospital Herlev, Copenhagen, Denmark.
Emma Hoppe HerlufsenUniversity of Copenhagen, Copenhagen, Denmark.
Jesper Kiehn SørensenDepartment of Paediatrics and Adolescent Medicine, Danish National University Hospital "Rigshospitalet," Copenhagen, Denmark.
Michelle MalonDepartment of Paediatrics and Adolescent Medicine, Danish National University Hospital "Rigshospitalet," Copenhagen, Denmark.
Jannet SvenssonChild and Adolescent Department, University Hospital Herlev, Copenhagen, Denmark.
Lone Graff StensballeDepartment of Paediatrics and Adolescent Medicine, Danish National University Hospital "Rigshospitalet," Copenhagen, Denmark.
Copenhagen University Hospital · DKHerlev Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo test for potential non-specific effects of an additional, early measles, mumps, and rubella (MMR) vaccine at age 5-7 months on risk of infection related hospitalisation before age 12 months.

designRandomised, double blinded, placebo controlled trial.

settingDenmark, a high income setting with low exposure to MMR.

participants6540 Danish infants aged 5 to 7 months.

interventionsInfants were randomly allocated 1:1 to intramuscular injection with standard titre MMR vaccine (M-M-R VaxPro) or placebo (solvent only).

main outcome measuresHospitalisations for infection, defined as all hospital contacts of infants referred from primary care for hospital evaluation and with an infection diagnosed, analysed as recurrent events, from randomisation to 12 months of age. In secondary analyses implications of censoring for date of subsequent diphtheria, tetanus, pertussis, polio,

results6536 infants were included in the intention-to-treat analysis. 3264 infants randomised to MMR vaccine experienced 786 hospitalisations for infection before age 12 months compared with 762 for the 3272 infants randomised to placebo. In the intention-to-treat analysis the rate of hospitalisations for infection did not differ between the MMR vaccine and placebo groups (hazard ratio 1.03, 95% confidence interval 0.91 to 1.18). For infants randomised to MMR vaccine compared with those randomised to placebo, the hazard ratio of hospitalisations for infection with a duration of at least 12 hours was 1.25 (0.88 to 1.77), and for prescriptions of antibiotics was 1.04 (0.88 to 1.23). No significant effect modifications were found by sex, prematurity, age at randomisation, or season. The estimate did not change when censoring at the date infants received DTaP-IPV-Hib+PCV after randomisation (1.02, 0.90 to 1.16).

conclusionFindings of this trial conducted in Denmark, a high income setting, do not support the hypothesis that live attenuated MMR vaccine administered early to infants aged 5-7 months decreases the rate of hospitalisations for non-targeted infection before age 12 months.

trial registrationEU Clinical Trials Registry EudraCT 2016-001901-18 and ClinicalTrials.gov NCT03780179.

Indexed as

Haemophilus VaccinesMeaslesMumpsDiphtheria-Tetanus-Pertussis VaccineHospitalizationHumansImmunizationInfantMeasles-Mumps-Rubella VaccinePoliovirus Vaccine, InactivatedDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesMeasles-Mumps-Rubella VaccinePoliovirus Vaccine, Inactivated

Identifiers

PMID37286215
PMCPMC10245144
OpenAlexW4379645841

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.