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Published VersionCC BY-NC-ND V4.0, Open Access
Journal article
Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults
Clinical Infectious Diseases, Vol.78(5), pp.1360-1368
2024
PMID: 37992000
Abstract
Background
Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines.
Methods
The primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein–based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% confidence interval >.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data.
Results
Of 1403 participants randomized, 1399 received vaccinations (median age, 70; range, 65‒91 years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin.
Conclusions
The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older-adult population.
Details
- Title
- Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults
- Authors
- Eugene Athan - Barwon HealthJames Baber - PfizerKaren Quan - PfizerRobert J Scott - University of the Sunshine Coast, Queensland, UniSC Clinical Trials CentreAnna Jaques - PfizerQin Jiang - PfizerWen Li - PfizerDavid Cooper - PfizerMark W Cutler - PfizerElena V Kalinina - PfizerAnnaliesa S Anderson - PfizerKena A Swanson - PfizerWilliam C Gruber - PfizerAlejandra Gurtman - PfizerBeate Schmoele-Thoma - PfizerStudy C3671006 Investigator Group (Research Group)
- Publication details
- Clinical Infectious Diseases, Vol.78(5), pp.1360-1368
- Publisher
- Oxford University Press
- Date published
- 2024
- DOI
- 10.1093/cid/ciad707
- ISSN
- 1537-6591; 1058-4838
- PMID
- 37992000
- Copyright note
- © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons AttributionNonCommercial-NoDerivs licence (https://reativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited.
- Data Availability
- Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data.
- Organisation Unit
- UniSC Clinical Trials Centre
- Language
- English
- Record Identifier
- 991036398602621
- Output Type
- Journal article
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