Evidence map›Paper›PMID 41994955›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: A Randomized, Non-inferiority Trial.

Isabel Leroux-Roels, Muriel Lins, Ronald Surowitz, Antoinette Pragalos, Paulia Kwo Ton Ge Jua, Dominique Wauters, Amulya Jayadev, Jacqueline Elaine Akite, Archana M Jastorff, Vicky Cárdenas and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence TrialClinical Trial, Phase III
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, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05879107 (A Phase III, Open-label, Randomized, Controlled, Multi-Country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co Administered With PCV20 in Adults Aged 60\xa0Years and Older), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05879107 phase3completednot on this map

A Phase III, Open-label, Randomized, Controlled, Multi-Country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co Administered With PCV20 in Adults Aged 60\xa0Years and Older

TypeinterventionalSponsorGlaxoSmithKlineRan2023 to 2024Enrolled1,113ConditionsRespiratory Syncytial Virus InfectionsArmsRSVPreF3 OA investigational vaccine, PCV20
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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.

Isabel Leroux-RoelsCenter for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.ORCID 0000-0002-5084-4696
Muriel LinsAZ Sint-Maarten, Mechelen, Department of Pulmonology, Belgium.ORCID 0009-0006-0989-4268
Ronald SurowitzJupiter Medical Center, Jupiter, Florida, USA.
Antoinette PragalosChrist Hospital, Cincinnati, Ohio, USA.
Paulia Kwo Ton Ge JuaGSK, Wavre, Belgium.
Dominique WautersGSK, Wavre, Belgium.
Amulya JayadevGSK, Bangalore, India.
Jacqueline Elaine AkiteGSK, Wavre, Belgium.
Archana M JastorffGSK, Wavre, Belgium.
Vicky CárdenasGSK, Rockville, Maryland, USA.ORCID 0009-0001-9890-6243
Marie Van der WielenGSK, Wavre, Belgium.ORCID 0009-0006-3808-8767
RSV-019 study group

Funding

GSK
6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) illness and pneumococcal disease present high disease burden and health risks to older adults. Vaccination against these 2 illnesses is a key strategy to reduce this burden, and co-administration of the 2 vaccines could enhance vaccine uptake. This study evaluated the immunogenicity, safety, and reactogenicity of co-administration of adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged ≥60 years.

methodsThis phase III, open-label, randomized, non-inferiority trial was conducted across 38 centers in Belgium, Poland, Spain, and the United States. Participants (N = 1112) were randomized 1:1 to receive adjuvanted RSVPreF3 vaccine and PCV20 vaccine either concomitantly (Co-Ad group) or 1 month apart (Control group). The primary objectives were to assess immunogenicity as measured by RSV-A and RSV-B neutralizing titers and opsonophagocytic titers for the PCV20 serotypes. Safety and reactogenicity were assessed as secondary objectives.

resultsAll primary immunogenicity objectives were met. The upper limit of the 95% confidence interval of the geometric mean titer ratios for RSV-A, RSV-B, and all 20 PCV20 serotypes was within the pre-defined non-inferiority margins. Safety profiles were similar across both groups, with most adverse events being mild to moderate in severity and of short duration. Serious adverse events and potential immune-mediated diseases were rare and unrelated to vaccination.

conclusionsCo-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake. CLINICAL TRIALS REGISTRATION: NCT05879107.

Indexed as

Immunogenicity, VaccinePneumococcal VaccinesRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesViral Fusion ProteinsAdjuvants, ImmunologicAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralFemaleHumansMaleMiddle AgedPneumococcal InfectionsRespiratory Syncytial Virus, HumanAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralF protein, human respiratory syncytial virusPneumococcal VaccinesRespiratory Syncytial Virus VaccinesVaccines, ConjugateViral Fusion Proteinsimmunogenicityolder adultspneumococcal conjugate vaccinerespiratory syncytial virussafety

Identifiers

PMID41994955
PMCPMC13644879

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.