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.

Last updated: March 24, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

TIV-HA formulation 2 at high dose

TIV-HA Vaccine formulation 1 at low dose

RSV/hMPV/PIV3 formulation 1 at low dose

Clinical Study ID

NCT06850051
VAV00030
U1111-1311-1743
  • Ages 18-49
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 to 49 years on the day of inclusion

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding and one of the following conditions applies:

  • Is of non-childbearing potential. To be considered of non-childbearingpotential, a female must be post-menopausal for at least 1 year, or surgicallysterile OR

  • Is of childbearing potential and agrees to use an effective contraceptivemethod or abstinence from at least 4 weeks prior to study interventionadministration until at least 4 weeks after study intervention administration.

Exclusion

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 Design

Total Participants: 270
Treatment Group(s): 9
Primary Treatment: TIV-HA formulation 2 at high dose
Phase: 1
Study Start date:
March 19, 2025
Estimated Completion Date:
October 31, 2025

Study Description

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

Connect with a study center

  • Paratus Clinical

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Paratus Clinical

    Herston, Queensland 4006
    Australia

    Active - Recruiting

  • University of Sunshine Coast Clinical Trials

    Morayfield, Queensland 4506
    Australia

    Active - Recruiting

  • University of Sunshine Coast Clinical Trials

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Griffith University

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Emeritus Research

    Camberwell, Victoria 3124
    Australia

    Active - Recruiting

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