Evidence map›Paper›PMID 25596202›Full record

Trial reportBMJ open2015

Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial.

Amanda Jane Leach, Edward Kim Mulholland, Mathu Santosham, Paul John Torzillo, Ngiare Joy Brown, Peter McIntyre, Heidi Smith-Vaughan, Sue Skull, Anne Balloch, Ross Andrews and 4 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. 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 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Panel 8: Vaccines and immunology.International journal of pediatric otorhinolaryngology · 2020
    Review
  12. Article
  13. 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.

Amanda Jane LeachChild Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia.
Edward Kim MulhollandCentre for International Child Health, Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia London School of Hygiene and Tropical Medicine, London, UK.
Mathu SantoshamJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Paul John TorzilloPrince Alfred Hospital, Sydney, New South Wales, Australia University of Sydney, Sydney, New South Wales, Australia.
Ngiare Joy BrownNational Aboriginal Community Controlled Health Organisation, Canberra, Australian Capital Territory, Australia.
Peter McIntyreNational Centre for Immunization Research and Surveillance, Sydney, New South Wales, Australia.
Heidi Smith-VaughanChild Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia.
Sue SkullUniversity of Western Australia, Perth, Western Australia, Australia.
Anne BallochMurdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia.
Ross AndrewsChild Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia.
Jonathan CarapetisTelethon Kids Institute, Perth, Western Australia, Australia.
Joseph McDonnellStrijen, The Netherlands.
Vicki KrauseNorthern Territory Department of Health & Families, Darwin, Northern Territory, Australia.
Peter Stanley MorrisChild Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia Department of Paediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOtitis media (OM) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory (NT). OM and associated hearing loss persist from infancy throughout childhood and often into adulthood. Educational and social opportunities are greatly compromised. Pneumococcus and non-typeable Haemophilus influenzae (NTHi) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life. Our hypothesis is that compared to current single vaccine schedules, a combination of vaccines starting at 1 month of age, may provide earlier, broadened protection. METHODS AND ANALYSES: This randomised outcome assessor, blinded controlled trial will recruit 425 infants between 28 and 38 days of age and randomly allocate them (1:1:1) to one of three pneumococcal conjugate vaccine (PCV) schedules: Synflorix at 2, 4, 6 months of age, Prevenar13 at 2, 4 and 6 months of age, or an investigational schedule of Synflorix at 1, 2 and 4 months plus Prevenar13 at 6 months of age. The blinded primary outcomes at 7 months of age are immunogenicity of specific vaccine antigens (geometric mean concentration (GMC) and proportion of participants with above threshold GMC of 0.35 µg/L). Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi, and any OM, including any tympanic membrane perforation. Parental interviews will provide data on common risk factors for OM. ETHICS AND DISSEMINATION: Ethical approval has been obtained from NT Department of Health and Menzies HREC (EC00153), Central Australian HREC (EC00155) and West Australian Aboriginal Health Ethics Committee (WAAHEC- 377-12/2011). Final trial results, data analyses, interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians, participating communities, local, national and international conferences, and published in peer-reviewed open access journals. TRIAL REGISTRATION NUMBERS: ACTRN12610000544077 and NCT01174849.

Indexed as

Immunization ScheduleAustraliaClinical ProtocolsFemaleHaemophilus InfectionsHaemophilus influenzaeHumansInfantInfant, NewbornMaleNasopharynxPneumococcal InfectionsPneumococcal VaccinesResearch DesignRiskStreptococcus pneumoniae13-valent pneumococcal vaccinePHiD-CV vaccinePneumococcal VaccinesVaccines, ConjugateIMMUNOLOGYMICROBIOLOGYPUBLIC HEALTH

Identifiers

PMID25596202
PMCPMC4298104

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.