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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-01-16

No results posted yet for this 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.

Conditions

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

Interventions

BIOLOGICAL

TIV-HA Vaccine formulation 1 at low dose

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

BIOLOGICAL

TIV-HA formulation 1 at high dose

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

BIOLOGICAL

TIV-HA formulation 2 at low dose

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

BIOLOGICAL

TIV-HA formulation 2 at high dose

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

BIOLOGICAL

RSV/hMPV/PIV3 formulation 2 at low dose

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

BIOLOGICAL

RSV/hMPV/PIV3 formulation 1 at high dose

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

BIOLOGICAL

RSV/hMPV/PIV3 formulation 2 at high dose

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

BIOLOGICAL

RSV/hMPV/PIV3 formulation 1 at low dose

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

BIOLOGICAL

RIV4 (Supemtek®)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2025-12-11
Completion
2025-12-11

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850051 on ClinicalTrials.gov