Evidence map›Paper›PMID 22739693›Full record

Trial reportClinical and vaccine immunology : CVI2012

Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults.

Robert W Frenck, Alejandra Gurtman, John Rubino, William Smith, Martin van Cleeff, Deepthi Jayawardene, Peter C Giardina, Emilio A Emini, William C Gruber, Daniel A Scott and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07242092 (Effect of Methotrexate Discontinuation on Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine), which is not on this map. Cited by 35 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 7 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.

NCT07242092 phase4recruitingnot on this mapstarted 2026, after this paper: background citation

Effect of Methotrexate Discontinuation on Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Patients With Autoimmune Rheumatic Diseases

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2026 to 2028Enrolled192ConditionsAutoimmune Rheumatic DiseasesArmsPneumococcal Vaccine
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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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

11 authors.

Robert W FrenckCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. robert.frenck@cchmc.org
Alejandra Gurtman
John Rubino
William Smith
Martin van Cleeff
Deepthi Jayawardene
Peter C Giardina
Emilio A Emini
William C Gruber
Daniel A Scott
Beate Schmöle-Thoma

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50 to 59 years (n = 1,116) received TIV with PCV13 (group 1) or placebo (group 2) (1:1 randomization); 1 month later, group 1 received placebo and group 2 received PCV13. A hemagglutination inhibition (HAI) assay for TIV and a standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG) were performed and opsonophagocytic activity (OPA) titers (assessed post hoc) were measured at baseline and 1 and 2 months postvaccination. The rises in HAI assay geometric mean titer (GMT) and percentage of participants in groups 1 and 2 with ≥ 4-fold increases in HAI responses (A/H1N1, 84.0% and 81.2%, respectively; A/H3N2, 71.1% and 69.5%, respectively; and B, 60.6% and 60.3%, respectively) were similar. In group 1, all serotypes met the predefined IgG geometric mean concentration (GMC) ratio noninferiority criterion relative to group 2, but GMCs were lower in group 1 than group 2. When comparing group 1 with group 2, 5 serotypes did not meet the OPA GMT ratio noninferiority criterion, and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in group 1 (86.2%) than group 2 (76.7%; P < 0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.

Indexed as

Antibodies, BacterialAntibodies, ViralDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsEnzyme-Linked Immunosorbent AssayFemaleHemagglutination Inhibition TestsHumansImmunoglobulin GInfluenza VaccinesMaleMiddle AgedOpsonin ProteinsPhagocytosisPlacebosPneumococcal Vaccines13-valent pneumococcal vaccineAntibodies, BacterialAntibodies, ViralImmunoglobulin GInfluenza VaccinesOpsonin ProteinsPlacebosPneumococcal Vaccines

Identifiers

PMID22739693
PMCPMC3416075

What OpenQuestion holds

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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.