Evidence map›Paper›PMID 39866854›Full record

ArticleEClinicalMedicine2025

Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial.

Gabriela Tapia-Calle, Gloria Aguilar, Nathalie Vaissiere, Carla Truyers, Pedro Ylisastigui, Erik Buntinx, Mathieu Le Gars, Frank Struyf, Gert Scheper, Macaya Douoguih and 2 more

Abstract read
In one paragraph

Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
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

12 authors.

Gabriela Tapia-CalleJanssen Vaccines and Prevention BV, Leiden, the Netherlands.
Gloria AguilarJanssen Vaccines and Prevention BV, Leiden, the Netherlands.
Nathalie VaissiereJanssen Research and Development, Beerse, Belgium.
Carla TruyersJanssen Research and Development, Beerse, Belgium.
Pedro YlisastiguiAlliance for Multispecialty Research, Fort Myers, Florida, USA.
Erik BuntinxAnimal Research Center, Alken, Belgium.
Mathieu Le GarsJanssen Vaccines and Prevention BV, Leiden, the Netherlands.
Frank StruyfJanssen Research and Development, Beerse, Belgium.
Gert ScheperJanssen Vaccines and Prevention BV, Leiden, the Netherlands.
Macaya DouoguihJanssen Vaccines and Prevention BV, Leiden, the Netherlands.
Javier Ruiz-GuiñazúJanssen Research and Development, Beerse, Belgium.
COV3005 Study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Vaccine co-administration can increase vaccination coverage. We assessed the safety, reactogenicity, and immunogenicity of concomitant administration of Ad26.COV2.S COVID-19 vaccine with seasonal influenza vaccines. Methods: This non-inferiority, Phase 3, randomised, double-blind study enrolled 859 healthy adults and was conducted between 02 November 2021 and 28 November 2022. Participants aged ≥18-64 years were randomised to receive a seasonal quadrivalent standard dose (SD) influenza vaccine ( Findings: Non-inferiority criteria for concomitant administration in the SD groups were met for SARS-CoV-2 Spike-specific antibodies (ratio 1.11, 95% CI 0.97-1.26) and haemagglutinin inhibition titres for all influenza strains (A/H3N2 1.23, 95% CI 1.05-1.45; B/Victoria 0.99, 95% CI 0.84-1.19; B/Yamagata, 1.03, 95% CI 0.88-1.21) except A/H1N1 (1.28, 95% CI 1.09-1.53) for which the upper limit of the 95% CI was >1.5. Concomitant administration of Ad26.COV2.S and SD influenza vaccine induced robust immune responses in terms of SARS-CoV-2 Spike-specific antibodies and haemagglutinin inhibition to all four influenza strains. Seroconversion and seroprotection rates against all influenza vaccine strains were comparable in the Coad and Control groups. Anti-Spike antibodies 28 days after receiving Ad26.COV2.S were similar whether administered with influenza vaccine or alone. Antibody responses persisted at least 6 months post-vaccination in all groups. The reactogenicity and safety profile following co-administration was consistent with the known safety profiles of the study vaccines. No safety concerns were identified. Coadministration was immunogenic and well tolerated in adults aged ≥65 years who received HD influenza vaccine. Interpretation: Co-administration of seasonal influenza vaccine with Ad26.COV2.S was immunogenic with an acceptable safety profile, supporting co-administration of these vaccines. Funding: Janssen Vaccines & Prevention BV and Biomedical Advanced Research and Development Authority.

Indexed as

Adenoviral vectorsCo-administrationCOVID-19Influenza vaccinesSARS-CoV-2Vaccine

Identifiers

PMID39866854
PMCPMC11764035

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Registered trials

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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.