Evidence map›Paper›PMID 30184183›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants.

William S Pomat, Anita H J van den Biggelaar, Sandra Wana, Jacinta P Francis, Vela Solomon, Andrew R Greenhill, Rebecca Ford, Tilda Orami, Megan Passey, Peter Jacoby and 4 more

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

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. 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 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  6. Differences in Pneumococcal andFrontiers in immunology · 2021
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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 at 4 institutions in 2 countries.

William S PomatPapua New Guinea Institute of Medical Research, Goroka.
Anita H J van den BiggelaarWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.
Sandra WanaPapua New Guinea Institute of Medical Research, Goroka.
Jacinta P FrancisPapua New Guinea Institute of Medical Research, Goroka.
Vela SolomonPapua New Guinea Institute of Medical Research, Goroka.
Andrew R GreenhillPapua New Guinea Institute of Medical Research, Goroka.
Rebecca FordPapua New Guinea Institute of Medical Research, Goroka.
Tilda OramiPapua New Guinea Institute of Medical Research, Goroka.
Megan PasseyThe University of Sydney, University Centre for Rural Health, School of Public Health, Lismore, New South Wales.
Peter JacobyDepartment of Biostatistics, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.
Lea-Ann KirkhamWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.
Deborah LehmannWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.
Peter C RichmondWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.
10v13v PCV Trial Team
The Kids Research Institute Australia · AUPapua New Guinea Institute of Medical Research · PGThe University of Sydney · AUFederation University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population.

methodsPCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age.

resultsOne month after the third dose of PCV10 or PCV13, ˃80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85-96) of children vaccinated with PCV10 and 81% (95% CI 72-88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events.

conclusionsInfant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. CLINICAL TRIALS REGISTRATION: NCT01619462.

Indexed as

Immunogenicity, VaccineAntibodies, BacterialFemaleHaemophilus InfectionsHaemophilus influenzaeHumansImmunoglobulin GInfantInfant, NewbornMalePapua New GuineaPatient SafetyPneumococcal VaccinesPneumonia, PneumococcalSerogroupStreptococcus pneumoniae10-valent pneumococcal conjugate vaccine13-valent pneumococcal vaccineAntibodies, BacterialImmunoglobulin GPneumococcal VaccinesantibodiescarriagePapua New Guineapneumococcal conjugate vaccineS. pneumonia

Identifiers

PMID30184183
PMCPMC6481999
OpenAlexW2890289760

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.