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.

Phase 1

Recruiting

• Conditions: Healthy Volunteers; Influenza Vaccination; Respiratory Syncytial Virus Vaccination; Parainfluenza Vaccination; Human Metapneumovirus Vaccination
• Interventions: Biological: TIV-HA formulation 1 at high dose; Biological: TIV-HA formulation 2 at high dose; Biological: TIV-HA Vaccine formulation 1 at low dose; Biological: TIV-HA formulation 2 at low dose; Biological: RSV/hMPV/PIV3 formulation 1 at high dose; Biological: RSV/hMPV/PIV3 formulation 2 at high dose; Biological: RSV/hMPV/PIV3 formulation 1 at low dose; Biological: RSV/hMPV/PIV3 formulation 2 at low dose; Biological: RIV4 (Supemtek®)

• Registration Number: NCT06850051
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-23
• Status Verified: 2025-03
• Study Start: 2025-03-19
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose	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.
Group 2 TIV-HA formulation 2 at high dose	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.
Group 3 TIV-HA formulation 1 at low dose	TIV-HA Vaccine 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.
Group 4 TIV-HA formulation 2 at low dose	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.
Group 5 RSV/hMPV/PIV3 formulation 1 at high dose	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.
Group 6 RSV/hMPV/PIV3 formulation 2 at high dose	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.
Group 7 RSV/hMPV/PIV3 formulation 1 at low dose	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.
Group 8 RSV/hMPV/PIV3 formulation 2 at low dose	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.
Group 9 recombinant influenza vaccine quadrivalent (RIV4)	RIV4 (Supemtek®)	Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.

Primary Outcome Measures

Name	Time	Method
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination	Within 30 minutes after each vaccination	Number of participants with unsolicited systemic AEs
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	Through 7 days after each vaccination	Number of participants with solicited injection site and systemic reactions
Presence of unsolicited AEs reported through 28 days after vaccination	Through 28 days after each vaccination	Number of participants with unsolicited AEs
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study	Throughout study, approximately 6 months	: Number of participants with SAEs and AESIs
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination	Through 7 days after vaccination	: Number of participants with out-of-range biological tests
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at 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	Day 1 and Day 29

Secondary Outcome Measures

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

Trial Locations

Locations (4)

University of Sunshine Coast Clinical Trials; 🇦🇺 South Brisbane, Queensland, Australia

Griffith University; 🇦🇺 Southport, Queensland, Australia

Emeritus Research; 🇦🇺 Camberwell, Victoria, Australia

Paratus Clinical; 🇦🇺 Herston, Queensland, Australia