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.

NCT06850051 | Completed Phase 1

• 2 other identifiers: VAV00030U1111-1311-1743
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 6

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.

Conditions

Healthy Volunteers; Influenza Vaccination; Respiratory Syncytial Virus Vaccination; Parainfluenza Vaccination; Human Metapneumovirus Vaccination

Keywords

influenza; respiratory syncytial virus; parainfluenza; human metapneumovirus

Outcome Measures

Primary Outcomes (7)

• Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after 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

  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

  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

  : 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

  : 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

  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 Outcomes (2)

• 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

Study Arms (9)

Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose

EXPERIMENTAL

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

Group 2 TIV-HA formulation 2 at high dose

EXPERIMENTAL

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

Group 3 TIV-HA formulation 1 at low dose

EXPERIMENTAL

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

Group 4 TIV-HA formulation 2 at low dose

EXPERIMENTAL

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

Group 5 RSV/hMPV/PIV3 formulation 1 at high dose

EXPERIMENTAL

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

Group 6 RSV/hMPV/PIV3 formulation 2 at high dose

EXPERIMENTAL

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

Group 7 RSV/hMPV/PIV3 formulation 1 at low dose

EXPERIMENTAL

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

Group 8 RSV/hMPV/PIV3 formulation 2 at low dose

EXPERIMENTAL

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

Group 9 recombinant influenza vaccine quadrivalent (RIV4)

ACTIVE COMPARATOR

Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.

Biological: RIV4 (Supemtek®)

Interventions

TIV-HA Vaccine formulation 1 at low dose BIOLOGICAL

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

Group 3 TIV-HA formulation 1 at low dose

TIV-HA formulation 1 at high dose BIOLOGICAL

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

Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose

TIV-HA formulation 2 at low dose BIOLOGICAL

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

Group 4 TIV-HA formulation 2 at low dose

TIV-HA formulation 2 at high dose BIOLOGICAL

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

Group 2 TIV-HA formulation 2 at high dose

RIV4 (Supemtek®) BIOLOGICAL

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

Group 9 recombinant influenza vaccine quadrivalent (RIV4)

RSV/hMPV/PIV3 formulation 2 at low dose BIOLOGICAL

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

Group 8 RSV/hMPV/PIV3 formulation 2 at low dose

RSV/hMPV/PIV3 formulation 1 at high dose BIOLOGICAL

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

Group 5 RSV/hMPV/PIV3 formulation 1 at high dose

RSV/hMPV/PIV3 formulation 2 at high dose BIOLOGICAL

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

Group 6 RSV/hMPV/PIV3 formulation 2 at high dose

RSV/hMPV/PIV3 formulation 1 at low dose BIOLOGICAL

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

Group 7 RSV/hMPV/PIV3 formulation 1 at low dose

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Paratus Clinical

Blacktown, New South Wales, 2148, Australia

Location

Paratus Clinical

Herston, Queensland, 4006, Australia

Location

University of Sunshine Coast Clinical Trials

Morayfield, Queensland, 4506, Australia

Location

University of Sunshine Coast Clinical Trials

South Brisbane, Queensland, 4101, Australia

Location

Griffith University

Southport, Queensland, 4215, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Influenza, Human; Paramyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Mononegavirales Infections

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 27, 2025
• Study Start: March 19, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (6)