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Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age

NCT07071558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age.

-Each participant will remain in the study for approximately 6 months.

* The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01).
* The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.

Conditions

  • Respiratory Syncytial Virus Immunization

Interventions

BIOLOGICAL

RSV vaccine formulation 8 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 6 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 7 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 1 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 2 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 3 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 4 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 5 dose

Suspension for injection. Route of administration: IM injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2026-03-17
Completion
2026-03-17

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071558 on ClinicalTrials.gov