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Investigational RSV vaccine 1

Phase 1

Respiratory Syncytial Virus Infections | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jul 30, 2026

Investigational RSV vaccine 1 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment213

FDA Designations

No designations recorded

Investigational RSV vaccine 1 clinical trials

Investigational RSV vaccine 1 · 1 trial · 1 indication

Phase 1 1
NCT06573281A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 YearsRespiratory Syncytial Virus Infections
COMPLETED213 Analytics
PHASE1COMPLETED
A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
Respiratory Syncytial Virus Infections
NCT06573281213
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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 to 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)

MEDIUMAug 30, 2026NCT06573281TRIAL_REMOVED: changed
MEDIUMAug 30, 2026NCT06573281TRIAL_REMOVED: changed
MEDIUMAug 30, 2026NCT06573281TRIAL_REMOVED: changed
HIGHJul 30, 2026NCT06573281Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 30, 2026NCT06573281Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about Investigational RSV vaccine 1

What is Investigational RSV vaccine 1?

Investigational RSV vaccine 1 is an mRNA-based vaccine candidate being developed by GSK plc for the prevention of respiratory syncytial virus infections. It is in Phase 1 clinical development and has been studied in healthy adults aged 18 to 45 years. It is not yet approved for use.

What is Investigational RSV vaccine 1 used for?

Investigational RSV vaccine 1 is being developed for the prevention of respiratory syncytial virus infections, an infectious disease of the respiratory tract. The Phase 1 study enrolled healthy adult volunteers aged 18 to 45 years to evaluate safety and immune response.

Who is developing Investigational RSV vaccine 1?

Investigational RSV vaccine 1 is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 clinical program for this mRNA-based RSV vaccine candidate.

What phase is Investigational RSV vaccine 1 in?

Investigational RSV vaccine 1 is in Phase 1 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA or any other regulatory authority. The completed Phase 1 trial was a randomized, double-blind, placebo-controlled study.

What clinical trials is Investigational RSV vaccine 1 in?

Investigational RSV vaccine 1 has been evaluated in one Phase 1 clinical trial, NCT06573281, titled a study on the safety and immune response to an mRNA-based RSV investigational vaccine in healthy adults aged 18 to 45 years. The trial is completed and enrolled 213 participants across the United States, Australia, and Spain.

How does Investigational RSV vaccine 1 work?

Investigational RSV vaccine 1 is an mRNA-based vaccine. It is designed to stimulate an immune response against respiratory syncytial virus. The Phase 1 trial assessed safety and immune response in healthy adults aged 18 to 45 years.

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