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.
- 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.
- Short title
- 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.
- Official title
- 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.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-12-11
- First posted
- 2025-02-27
- Registry last updated
- 2026-01-16
- Primary completion date
- 2025-12-11
- Start date
- 2025-03-19
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanofi
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06850051
- ClinicalTrials.gov ID
- NCT06850051
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Timeframe: Day 1 and Day 29
RSV B and hMPV A nAb titers at Day 1 and Day 29
Timeframe: Day 1 and Day 29
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Timeframe: Day 29
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 49 Years
- Healthy volunteers
- Yes
-
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.
- 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.
- Paratus ClinicalBlacktown, Australia
- Paratus ClinicalHerston, Australia
- University of Sunshine Coast Clinical TrialsMorayfield, Australia
- University of Sunshine Coast Clinical TrialsSouth Brisbane, Australia
- Griffith UniversitySouthport, Australia
- Emeritus ResearchCamberwell, Australia
Other registry identifiers
- U1111-1311-1743