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Completed

NCT Number: NCT06850051

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.

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.

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Key information

Conditions

Healthy Volunteers Human Metapneumovirus Vaccination Infections Influenza Vaccination Influenza, Human Mononegavirales Infections Orthomyxoviridae Infections Parainfluenza Vaccination Paramyxoviridae Infections RNA Virus Infections Respiratory Syncytial Virus Vaccination Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paratus Clinical, Blacktown, New South Wales, Australia

Loading trial locations.

About this study

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

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 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.

Treatment and study plan

TIV-HA Vaccine formulation 1 at low dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

TIV-HA formulation 1 at high dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

TIV-HA formulation 2 at low dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

TIV-HA formulation 2 at high dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

RSV/hMPV/PIV3 formulation 2 at low dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

RSV/hMPV/PIV3 formulation 1 at high dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

RSV/hMPV/PIV3 formulation 2 at high dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

RSV/hMPV/PIV3 formulation 1 at low dose

Biological

Suspension for injection in a vial. Route of administration: IM injection

RIV4 (Supemtek®)

Biological

Solution for injection in a prefilled syringe. Route of administration: IM injection

Primary outcomes

  1. 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

  2. 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

  3. Presence of unsolicited AEs reported through 28 days after vaccination

    Time frame: Through 28 days after each vaccination

    Number of participants with unsolicited AEs

  4. 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

  5. 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

  6. 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

  7. RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29

    Time frame: Day 1 and Day 29

Secondary outcomes

  1. RSV B and hMPV A nAb titers at Day 1 and Day 29

    Time frame: Day 1 and Day 29

  2. Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29

    Time frame: 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 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Jan 16, 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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