Evidence map›Paper›PMID 22112189›Full record

Trial reportBMC public health2011

Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial.

Alassane Dicko, Olumuyiwa O Odusanya, Abdoulbaki I Diallo, Gaoussou Santara, Amadou Barry, Amagana Dolo, Aminata Diallo, Yetunde A Kuyinu, Omolara A Kehinde, Nancy François and 4 more

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

Trial report in BMC public health, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00678301 (Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT00678301 phase3completednot on this map

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™

TypeinterventionalSponsorGlaxoSmithKlineRan2008 to 2009Enrolled365ConditionsInfections, StreptococcalArmsGSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™, GSK Biologicals' Zilbrix™ Hib
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
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  10. Pneumococcal vaccination: what have we learnt so far and what can we expect in the future?European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2015
    Review
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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 3 institutions in 3 countries.

Alassane DickoMalaria Research and Training Center, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, P,O, Box 1805, Bamako, Mali. adicko@mrtcbko.org
Olumuyiwa O Odusanya
Abdoulbaki I Diallo
Gaoussou Santara
Amadou Barry
Amagana Dolo
Aminata Diallo
Yetunde A Kuyinu
Omolara A Kehinde
Nancy François
Dorota Borys
Juan P Yarzabal
Marta Moreira
Lode Schuerman
University of Bamako · MLGlaxoSmithKline (Belgium) · BELagos State University · NG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPneumonia is still the leading cause of death among children in Africa, and pneumococcal serotypes 1 and 5 are frequently isolated from African children with invasive pneumococcal disease below the age of 5 years. The immunogenicity, safety and reactogenicity of 3-dose primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria.

methodsIn an open, randomized, controlled study, 357 infants received DTPw-HBV/Hib and OPV primary vaccination with (PHiD-CV group) or without (control group) PHiD-CV co-administration at 6, 10 and 14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured and adverse events (AEs) recorded.

resultsOne month post-dose 3, ≥ 97.2% of PHiD-CV-vaccinated infants had an antibody concentration ≥ 0.2 μg/mL for each vaccine pneumococcal serotype except for 6B (82.0%) and 23F (87.6%) versus < 10% in the control group except for serotypes 14 (35.7%) and 19F (22.5%). For each vaccine serotype, ≥ 93.3% of PHiD-CV recipients had an OPA titre ≥ 8, except for serotypes 1 (87.6%) and 6B (85.4%), compared to < 10% in the control group, except for serotypes 7F (42.9%), 9V (24.1%) and 14 (24.5%). Anti-protein D geometric mean antibody concentrations were 3791.8 and 85.4 EL.U/mL in the PHiD-CV and control groups, respectively. Overall incidences of solicited and unsolicited AEs were similar between groups.

conclusionsIn sub-Saharan African infants, PHiD-CV was immunogenic for all vaccine pneumococcal serotypes and protein D. Vaccine tolerability was generally comparable between the PHiD-CV and control groups.

trial registrationClinicalTrials.gov identifier: NCT00678301.

Indexed as

Primary PreventionAfrica South of the SaharaBacterial ProteinsCarrier ProteinsFemaleHaemophilus InfectionsHaemophilus influenzaeHumansImmunoglobulin DInfantLipoproteinsMaleMaliNigeriaPneumococcal Vaccines10-valent pneumococcal vaccineBacterial ProteinsCarrier ProteinsglpQ protein, Haemophilus influenzaeImmunoglobulin DLipoproteinsPneumococcal Vaccines

Identifiers

PMID22112189
PMCPMC3267728
OpenAlexW2050224530

What OpenQuestion holds

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LicenceCC BY
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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.