Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older
15. september 2026 opdateret af: Sanofi
A Phase 2b, Randomized, Placebo-controlled, Observer-blind Study in Adults 60 Years of Age and Older to Evaluate the Efficacy, Safety, and Immunogenicity of a Bivalent Protein Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.
The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).
The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
8000
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Studiesteder
-
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Australian Capital Territory
-
Bruse, Australian Capital Territory, Australien, 2617
- Rekruttering
- Investigational Site Number : 0360008
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New South Wales
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Blacktown, New South Wales, Australien, 2148
- Rekruttering
- Investigational Site Number : 0360006
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Maroubra, New South Wales, Australien, 2035
- Rekruttering
- Investigational Site Number : 0360007
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Queensland
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Albion, Queensland, Australien, 4010
- Rekruttering
- Investigational Site Number : 0360002
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Sippy Downs, Queensland, Australien, 4556
- Rekruttering
- Investigational Site Number : 0360003
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Victoria
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Melbourne, Victoria, Australien, 3124
- Rekruttering
- Investigational Site Number : 0360009
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London, Det Forenede Kongerige, SW10 0LR
- Rekruttering
- Investigational Site Number : 8260004
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Cardiff [Caerdydd Gb-crd]
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Cardiff, Cardiff [Caerdydd Gb-crd], Det Forenede Kongerige, CF15 9SS
- Rekruttering
- Investigational Site Number : 8260012
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Dorset
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Bournemouth, Dorset, Det Forenede Kongerige, BH7 7DW
- Rekruttering
- Investigational Site Number : 8261010
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Dorchester, Dorset, Det Forenede Kongerige, DT1 2JY
- Rekruttering
- Investigational Site Number : 8263010
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England
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London, England, Det Forenede Kongerige, SW10 9NH
- Rekruttering
- Investigational Site Number : 8260011
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Hampshire
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Portsmouth, Hampshire, Det Forenede Kongerige, PO6 3LY
- Rekruttering
- Investigational Site Number : 8262010
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Lancashire
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Blackpool, Lancashire, Det Forenede Kongerige, FY3 7EN
- Rekruttering
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Det Forenede Kongerige, NW10 2PB
- Rekruttering
- Investigational Site Number : 8260007
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Oxfordshire
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Witney, Oxfordshire, Det Forenede Kongerige, OX28 6JS
- Rekruttering
- Investigational Site Number : 8260005
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Wirral
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West Kirby, Wirral, Det Forenede Kongerige, CH48 5AA
- Rekruttering
- Investigational Site Number : 8260006
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Aged 60 years or older on the day of inclusion
- Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion
Exclusion Criteria:
- Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded
- Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Previous history of Guillain-Barré Syndrome (GBS)
- Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Safety Lead-in Cohort - Experimental
Single administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate
|
IM injection
Andre navne:
|
|
Placebo komparator: Safety Lead-in Cohort - Placebo
Single administration of matching placebo
|
IM injektion
|
|
Eksperimentel: Main Cohort - Experimental
Single administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate
|
IM injection
Andre navne:
|
|
Placebo komparator: Main Cohort - Placebo
Single administration of matching placebo
|
IM injektion
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
Tidsramme: From 14 days to 12 months after vaccination
|
From 14 days to 12 months after vaccination
|
|
Occurrence of the first episode of HMPV-LRTD
Tidsramme: From 14 days to 12 months after vaccination
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From 14 days to 12 months after vaccination
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD
Tidsramme: From 14 days to 12 months after vaccination
|
From 14 days to 12 months after vaccination
|
|
Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD
Tidsramme: From 14 days to 12 months after vaccination
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From 14 days to 12 months after vaccination
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Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD
Tidsramme: From 14 days to 12 months after vaccination
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From 14 days to 12 months after vaccination
|
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Occurrence of the first episode of RSV-URTD and/or HMPV-URTD
Tidsramme: From 14 days to 12 months after vaccination
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From 14 days to 12 months after vaccination
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RSV A, RSV B, and HMPV A, HMPV B serum nAb titers in a subset of participants
Tidsramme: At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination
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At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination
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Presence of immediate unsolicited systemic AEs (Adverse Events)
Tidsramme: Within 30 minutes after vaccination
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Within 30 minutes after vaccination
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Presence of solicited injection site and systemic reactions in a subset of participants
Tidsramme: Up to 7 days after vaccination
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Up to 7 days after vaccination
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Presence of unsolicited AEs reported
Tidsramme: Up to 27 days after vaccination
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Up to 27 days after vaccination
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Presence of MAAEs (Medically Attended Adverse Events)
Tidsramme: Within 6 months after vaccination
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Within 6 months after vaccination
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Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Event of Special Interest)
Tidsramme: Within 6 months after vaccination
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Within 6 months after vaccination
|
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Presence of related SAEs, related AESIs, and fatal SAEs
Tidsramme: Up to 12 months post-vaccination
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Up to 12 months post-vaccination
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Presence of out-of-range biological test results in a subset of participants
Tidsramme: 7 days after vaccination
|
7 days after vaccination
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. september 2026
Primær færdiggørelse (Anslået)
3. juli 2028
Studieafslutning (Anslået)
5. juli 2028
Datoer for studieregistrering
Først indsendt
3. september 2026
Først indsendt, der opfyldte QC-kriterier
3. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- VCA25397
- 2026-526177-42 (Registry Identifier: CTIS)
- U1111-1337-5133 (Registry Identifier: ICTRP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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