Evidence map›Paper›PMID 29299402›Full record

ArticlePneumonia (Nathan Qld.)2017

Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea.

Deborah Lehmann, Wendy Kirarock, Anita H J van den Biggelaar, Megan Passey, Peter Jacoby, Gerard Saleu, Geraldine Masiria, Birunu Nivio, Andrew Greenhill, Tilda Orami and 7 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pneumonia (Nathan Qld.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01619462 (A Study of Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines to Inform Policy Regarding Pneumococcal Vaccination of Papua New Guinean Children), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 35% 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.

NCT01619462 phase3unknown statusnot on this map

A Study of Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines to Inform Policy Regarding Pneumococcal Vaccination of Papua New Guinean Children

TypeinterventionalSponsorPapua New Guinea Institute of Medical ResearchRan2011 to 2016Enrolled200ConditionsPneumonia, Meningitis, Bacteraemia, SepsisArmsPrevenar 13 and Synflorix
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Differences in Pneumococcal andFrontiers in immunology · 2021
    Trial
  3. Trial
  4. Article
  5. 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

17 authors at 4 institutions in 2 countries.

Deborah LehmannTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
Wendy KirarockPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Anita H J van den BiggelaarTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
Megan PasseyThe University of Sydney, University Centre for Rural Health, School of Public Health, 61 Uralba Street, Lismore, NSW 2480 Australia.
Peter JacobyTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
Gerard SaleuPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Geraldine MasiriaPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Birunu NivioPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Andrew GreenhillTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
Tilda OramiPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Jacinta FrancisPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Rebecca FordPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Lea-Ann KirkhamTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
Vela SolomonPapua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province 441 Papua New Guinea.
Peter C RichmondTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
William S PomatTelethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, WA 6008 Australia.
10v13v PCV trial team
The Kids Research Institute Australia · AUPapua New Guinea Institute of Medical Research · PGFederation University · AUThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren in third-world settings including Papua New Guinea (PNG) experience early onset of carriage with a broad range of pneumococcal serotypes, resulting in a high incidence of severe pneumococcal disease and deaths in the first 2 years of life. Vaccination trials in high endemicity settings are needed to provide evidence and guidance on optimal strategies to protect children in these settings against pneumococcal infections.

methodsThis report describes the rationale, objectives, methods, study population, follow-up and specimen collection for a vaccination trial conducted in an endemic and logistically challenging setting in PNG. The trial aimed to determine whether currently available pneumococcal conjugate vaccines (PCV) are suitable for use under PNG's accelerated immunization schedule, and that a schedule including pneumococcal polysaccharide vaccine (PPV) in later infancy is safe and immunogenic in this high-risk population.

resultsThis open randomized-controlled trial was conducted between November 2011 and March 2016, enrolling 262 children aged 1 month between November 2011 and April 2014. The participants were randomly allocated (1:1) to receive 10-valent PCV (10vPCV) or 13-valent PCV (13vPCV) in a 1-2-3-month schedule, with further randomization to receive PPV or no PPV at age 9 months, followed by a 1/5

conclusionLaboratory testing of the many samples collected during this trial will determine the impact of the different vaccine schedules and formulations on nasopharyngeal carriage, antibody production and function, and immune memory. The final data will inform policy on pneumococcal vaccine schedules in countries with children at high risk of pneumococcal disease by providing direct comparison of an accelerated schedule of 10vPCV and 13vPCV and the potential advantages of PPV following PCV immunization.

trial registrationClinicalTrials.gov CTN NCT01619462, retrospectively registered on May 28, 2012.

Indexed as

Papua New GuineaPCVPneumococcalPneumococcal conjugate vaccinePneumococcal polysaccharide vaccinePPVRandomized controlled trialRCTVaccine

Identifiers

PMID29299402
PMCPMC5742486
OpenAlexW2771453728

What OpenQuestion holds

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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.