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Investigational RSV vaccine 1

Phase 1

Respiratory Syncytial Virus Infections | Monoclonal antibody | Respiratory |GSK plc|Last Updated: Sep 8, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment213
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06573281A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 YearsPHASE1 ACTIVE NOT_RECRUITING 213 — — Sep 30, 2024Apr 13, 2026Sep 8, 20259 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of participants reporting solicited administration site events within 7 days post-Dose 1
From Day 1 to Day 7
Number of participants reporting solicited administration site events within 7 days post-Dose 2
From Day 30 to Day 36
Number of participants reporting solicited systemic events within 7 days post-Dose 1
From Day 1 to Day 7
Number of participants reporting solicited systemic events within 7 days post-Dose 2
From Day 30 to Day 36
Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1
From Day 1 to Day 29
Number of participants reporting unsolicited AEs within 29 days post-Dose 2
From Day 30 to Day 58
Number of participants reporting serious adverse events (SAEs)
From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting medically attended adverse events (MAAEs)
From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting adverse event of special interest (AESI)
From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting fatal SAEs
From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related SAEs
From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related AESIs
From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants with clinically significant hematological and biochemical abnormalities at pre-Dose 1
At Day 1
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
At Day 8
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2
At Day 37
Secondary Endpoints
RSV- A neutralizing titers expressed as Geometric mean titers (GMTs)
At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2)
RSV- B neutralizing titers expressed as GMTs
At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2)
Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline
Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
RSV_Group AEXPERIMENTAL -
RSV_Group BEXPERIMENTAL -
RSV_Group CEXPERIMENTAL -
RSV_Group DEXPERIMENTAL -
RSV_Group EEXPERIMENTAL -
RSV_Group FEXPERIMENTAL -
Placebo GroupPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Investigational RSV vaccine 1BIOLOGICALInvestigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 2BIOLOGICALInvestigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 3BIOLOGICALInvestigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 4BIOLOGICALInvestigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 5BIOLOGICALInvestigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 6BIOLOGICALInvestigational RSV vaccine 6 administered intramuscularly on Day 1.
PlaceboDRUGPlacebo administered intramuscularly on Day 1 and Day 30 and for RSV\_Group F placebo administered only on Day 30.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits). * Written informed consent obtained from the participant prior to performance of any study-specific p...

Countries:United StatesAustraliaSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06573281primaryCompletionDate: changed
LOWMay 24, 2026NCT06573281studyFirstPostDate: changed