Evidence map›Paper›PMID 33685411›Full record

Trial reportBMC pediatrics2021

Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial.

Amanda Jane Leach, Edward Kim Mulholland, Mathuram Santosham, Paul John Torzillo, Peter McIntyre, Heidi Smith-Vaughan, Nicole Wilson, Beth Arrowsmith, Jemima Beissbarth, Mark D Chatfield and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01174849 (A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT01174849 phase4completednot on this map

A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants (PREV-IX_COMBO): Immunogenicity, Carriage and Otitis Media Outcomes

TypeinterventionalSponsorMenzies School of Health ResearchRan2011 to 2018Enrolled425ConditionsOtitis MediaArmsSynflorix, Prevenar13, COMBO
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. 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

12 authors at 7 institutions in 3 countries.

Amanda Jane LeachChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia. amanda.leach@menzies.edu.au.ORCID 0000-0002-4638-8392
Edward Kim MulhollandMurdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia.
Mathuram SantoshamJohns Hopkins Bloomberg School of Public Health, Baltimore, USA.
Paul John TorzilloPrince Alfred Hospital, Sydney, NSW, Australia.
Peter McIntyreNational Centre for Immunization Research and Surveillance, Sydney, NSW, Australia.
Heidi Smith-VaughanChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Nicole WilsonChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Beth ArrowsmithChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Jemima BeissbarthChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Mark D ChatfieldChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Victor M OguomaChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Peter Stanley MorrisChild Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.
Charles Darwin University · AUJohns Hopkins University · USNational Centre for Immunisation Research & Surveillance · AUThe University of Melbourne · AUThe University of Queensland · AUThe University of Sydney · AUUniversity of Canberra · AU

Funding

Financial Markets Foundation for Children 2012-057National Health and Medical Research Council 605810
6 · The paper itself

Abstract

backgroundAboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months.

methodsIn an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2-4-6 months (_PPP), Synflorix™ (S) at 2-4-6 months (_SSS), or Synflorix™ at 1-2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM).

resultsBetween September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM.

conclusionsDespite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life.

trial registrationACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.gov NCT01174849 registered 04/08/2010.

Indexed as

Otitis MediaPneumococcal InfectionsAustraliaChildHaemophilus influenzaeHumansInfantPneumococcal VaccinesVaccines, Conjugate13-valent pneumococcal vaccinePneumococcal VaccinesVaccines, Conjugate3-arm randomised controlled trialAboriginalCombination scheduleHead-to-headInfantOtitis mediaPCV13PHiD-CV10Pneumococcal conjugate vaccines

Identifiers

PMID33685411
PMCPMC7938290
OpenAlexW3131338075

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.