A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.

January 14, 2026 updated by: Sanofi

A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age.

The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.

Overall, the study is designed to:

  • Assess the safety profile of the candidate formulations
  • Describe the immunogenicity profile of the candidate formulations
  • Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.

Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).

Participants will also be required to record their daily temperature on the diary.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of study participation will be approximately 6 months for each participant.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Paratus Clinical
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Paratus Clinical
      • Morayfield, Queensland, Australia, 4506
        • University of Sunshine Coast Clinical Trials
      • South Brisbane, Queensland, Australia, 4101
        • University of Sunshine Coast Clinical Trials
      • Southport, Queensland, Australia, 4215
        • Griffith University
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 one of the following conditions applies:

    • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR
    • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.

Exclusion Criteria:

- Any medical condition or circumstance which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Biological: TIV-HA formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 2 TIV-HA formulation 2 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Biological: TIV-HA formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 3 TIV-HA formulation 1 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Biological: TIV-HA Vaccine formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 4 TIV-HA formulation 2 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Biological: TIV-HA formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 5 RSV/hMPV/PIV3 formulation 1 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Biological: RSV/hMPV/PIV3 formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 6 RSV/hMPV/PIV3 formulation 2 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Biological: RSV/hMPV/PIV3 formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 7 RSV/hMPV/PIV3 formulation 1 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Biological: RSV/hMPV/PIV3 formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Experimental: Group 8 RSV/hMPV/PIV3 formulation 2 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Biological: RSV/hMPV/PIV3 formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Active Comparator: Group 9 recombinant influenza vaccine quadrivalent (RIV4)
Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.
Biological: RIV4 (Supemtek®)
Solution for injection in a prefilled syringe. Route of administration: IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Time Frame: Within 30 minutes after each vaccination
Number of participants with unsolicited systemic AEs
Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Time Frame: Through 7 days after each vaccination
Number of participants with solicited injection site and systemic reactions
Through 7 days after each vaccination
Presence of unsolicited AEs reported through 28 days after vaccination
Time Frame: Through 28 days after each vaccination
Number of participants with unsolicited AEs
Through 28 days after each vaccination
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
Time Frame: Throughout study, approximately 6 months
: Number of participants with SAEs and AESIs
Throughout study, approximately 6 months
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Time Frame: Through 7 days after vaccination
: Number of participants with out-of-range biological tests
Through 7 days after vaccination
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
Time Frame: Day 1 and Day 29
Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Time Frame: Day 1 and Day 29
Day 1 and Day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
RSV B and hMPV A nAb titers at Day 1 and Day 29
Time Frame: Day 1 and Day 29
Day 1 and Day 29
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Time Frame: Day 29
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Actual)

December 11, 2025

Study Completion (Actual)

December 11, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAV00030
  • U1111-1311-1743 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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