Evidence map›Paper›PMID 38134393›Full record

Trial reportThe Journal of infectious diseases2024

Concomitant Administration of Ad26.RSV.preF/RSV preF Protein Vaccine and High-Dose Influenza Vaccine in Adults 65 Years and Older: A Noninferiority Trial.

Widagdo Widagdo, Arangassery Rosemary Bastian, Archana M Jastorff, Ilse Scheys, Els De Paepe, Christy A Comeaux, Nynke Ligtenberg, Benoit Callendret, Esther Heijnen

Open access · hybridAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. 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

9 authors at 2 institutions in 2 countries.

Widagdo WidagdoJanssen Vaccines and Prevention B.V., Leiden, The Netherlands.
Arangassery Rosemary BastianJanssen Vaccines and Prevention B.V., Leiden, The Netherlands.
Archana M JastorffJanssen Research and Development.
Ilse ScheysJanssen Research and Development.
Els De PaepeJanssen Infectious Diseases, Beerse, Belgium.
Christy A ComeauxJanssen Vaccines and Prevention B.V., Leiden, The Netherlands.
Nynke LigtenbergJanssen Vaccines and Prevention B.V., Leiden, The Netherlands.
Benoit CallendretJanssen Vaccines and Prevention B.V., Leiden, The Netherlands.
Esther HeijnenJanssen Vaccines and Prevention B.V., Leiden, The Netherlands.
Janssen (Netherlands) · NLJanssen (Belgium) · BE

Funding

Janssen Vaccines and Prevention B.V.
6 · The paper itself

Abstract

backgroundSince influenza and respiratory syncytial virus (RSV) carry significant burden in older adults with overlapping seasonality, vaccines for both pathogens would ideally be coadministered in this population. Here we evaluate the immunogenicity and safety of concomitant administration of Ad26.RSV.preF/RSV preF protein and high-dose seasonal influenza vaccine (Fluzone-HD) in adults ≥65 years old.

methodsParticipants were randomized 1:1 to the Coadministration or Control group. The Coadministration group received concomitant Ad26.RSV.preF/RSV preF protein and Fluzone-HD on day 1 and placebo on day 29, while the Control group received Fluzone-HD and placebo on day 1 and Ad26.RSV.preF/RSV preF protein on day 29. Influenza hemagglutination-inhibiting and RSV preF-binding antibody titers were measured postvaccination and tested for noninferiority between both groups. Safety data were collected throughout the study and analyzed descriptively.

resultsCoadministered Ad26.RSV.preF/RSV preF protein and Fluzone-HD vaccines induced noninferior immune responses compared to each vaccine administered alone. Seroconversion and seroprotection rates against influenza were similar between groups. Both vaccines remained well tolerated upon concomitant administration.

conclusionsCoadministration of Ad26.RSV.preF/RSV preF protein and Fluzone-HD showed an acceptable safety profile and did not hamper the immunogenicity of either vaccine, thus supporting that both vaccines can be concomitantly administered in adults ≥65 years old.

Indexed as

Antibodies, ViralInfluenza, HumanInfluenza VaccinesRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAgedAged, 80 and overDouble-Blind MethodFemaleHemagglutination Inhibition TestsHumansImmunogenicity, VaccineMaleRespiratory Syncytial Virus, HumanVaccines, CombinedAntibodies, ViralInfluenza VaccinesRespiratory Syncytial Virus VaccinesVaccines, CombinedAd26.RSV.preF/RSV preF proteinFluzone-HDinfluenzanoninferiorityrespiratory syncytial virus

Identifiers

PMID38134393
PMCPMC11326816
OpenAlexW4390096910

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.