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Completed

NCT Number: NCT07071558

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

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.

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Key information

Conditions

Respiratory Syncytial Virus Immunization Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site # 0361003, Wollongong, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 49 years on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
  • Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
  • Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

Exclusion criteria

  • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

RSV vaccine formulation 1 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 2 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 3 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 4 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 5 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 6 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 7 dose

Biological

Suspension for injection. Route of administration: IM injection

RSV vaccine formulation 8 dose

Biological

Suspension for injection. Route of administration: IM injection

Primary outcomes

  1. Presence of any unsolicited systemic adverse events (aes)

    Time frame: Within 30 minutes after each vaccine injection

    Number of participants experiencing immediate AEs

  2. Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)

    Time frame: Through 7 days after each vaccine injection

    Number of participants experiencing solicited injection site reactions

  3. Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)

    Time frame: Through 7 days after each vaccine injection

    Number of participants experiencing solicited systemic reactions

  4. Presence of unsolicited AEs

    Time frame: Day 1 through day 29

    Number of participants experiencing unsolicited AEs

  5. Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)

    Time frame: Throughout study, approximately 6 months

    Number of participants experiencing SAEs and AESIs

  6. Presence of out-of-range biological test results (including shift from baseline values)

    Time frame: Through 7 days after each vaccine injection

    number of participants with out-of-range biological tests

  7. RSV A nAb (Neutralizing Antibodies) titers

    Time frame: At day 1 and day 29

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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