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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.
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.
The duration of study participation will be approximately 6 months for each participant.
Age
18 - 49 years
Sex
ALL
Healthy Volunteers
Yes
Paratus Clinical
Blacktown, New South Wales, Australia
Paratus Clinical
Herston, Queensland, Australia
University of Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
University of Sunshine Coast Clinical Trials
South Brisbane, Queensland, Australia
Griffith University
Southport, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Start Date
March 19, 2025
Primary Completion Date
December 11, 2025
Completion Date
December 11, 2025
Last Updated
January 16, 2026
270
ACTUAL participants
TIV-HA Vaccine formulation 1 at low dose
BIOLOGICAL
TIV-HA formulation 1 at high dose
BIOLOGICAL
TIV-HA formulation 2 at low dose
BIOLOGICAL
TIV-HA formulation 2 at high dose
BIOLOGICAL
RSV/hMPV/PIV3 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
RIV4 (Supemtek®)
BIOLOGICAL
Lead Sponsor
Sanofi
NCT07310264
NCT06342713
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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