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Investigational RSV vaccine 1

Phase 1

Respiratory Syncytial Virus Infections | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jul 30, 2026

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

Clinical trial landscape

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 used for?

Investigational RSV vaccine 1 is a monoclonal antibody being developed for the prevention of Respiratory Syncytial Virus (RSV) infections. It is currently in Phase 1 clinical development and is intended for use in healthy adults aged 18 to 45 years.

Who makes Investigational RSV vaccine 1?

Investigational RSV vaccine 1 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immune response of this investigational vaccine.

What phase is Investigational RSV vaccine 1 in?

Investigational RSV vaccine 1 is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine is not yet available for commercial use.

What clinical trials is Investigational RSV vaccine 1 in?

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

How does Investigational RSV vaccine 1 work?

Investigational RSV vaccine 1 is a monoclonal antibody designed to target Respiratory Syncytial Virus. While the specific molecular target is not disclosed, as a monoclonal antibody, it is intended to neutralize the virus and prevent infection. The vaccine is being studied for its ability to generate an immune response against RSV.