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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06850051




Registration number
NCT06850051
Ethics application status
Date submitted
11/02/2025
Date registered
25/03/2025
Date last updated
27/03/2025

Titles & IDs
Public 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.
Scientific 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.
Secondary ID [1] 0 0
U1111-1311-1743
Secondary ID [2] 0 0
VAV00030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Influenza Vaccination 0 0
Respiratory Syncytial Virus Vaccination 0 0
Parainfluenza Vaccination 0 0
Human Metapneumovirus Vaccination 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - TIV-HA Vaccine formulation 1 at low dose
Treatment: Other - TIV-HA formulation 1 at high dose
Treatment: Other - TIV-HA formulation 2 at low dose
Treatment: Other - TIV-HA formulation 2 at high dose
Treatment: Other - RSV/hMPV/PIV3 formulation 2 at low dose
Treatment: Other - RSV/hMPV/PIV3 formulation 1 at high dose
Treatment: Other - RSV/hMPV/PIV3 formulation 2 at high dose
Treatment: Other - RSV/hMPV/PIV3 formulation 1 at low dose
Treatment: Other - RIV4 (Supemtek®)

Experimental: Group 1 trivalent influenza vaccine-hemagglutinin (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.

Experimental: Group 2 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.

Experimental: Group 3 TIV-HA 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.

Experimental: Group 4 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.

Experimental: Group 5 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.

Experimental: Group 6 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.

Experimental: Group 7 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.

Experimental: Group 8 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.

Active comparator: Group 9 recombinant influenza vaccine quadrivalent (RIV4) - Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.


Treatment: Other: TIV-HA Vaccine formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: TIV-HA formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: TIV-HA formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: TIV-HA formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: RSV/hMPV/PIV3 formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: RSV/hMPV/PIV3 formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: RSV/hMPV/PIV3 formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: RSV/hMPV/PIV3 formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection

Treatment: Other: RIV4 (Supemtek®)
Solution for injection in a prefilled syringe. Route of administration: IM injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Assessment method [1] 0 0
Number of participants with unsolicited systemic AEs
Timepoint [1] 0 0
Within 30 minutes after each vaccination
Primary outcome [2] 0 0
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
Assessment method [2] 0 0
Number of participants with solicited injection site and systemic reactions
Timepoint [2] 0 0
Through 7 days after each vaccination
Primary outcome [3] 0 0
Presence of unsolicited AEs reported through 28 days after vaccination
Assessment method [3] 0 0
Number of participants with unsolicited AEs
Timepoint [3] 0 0
Through 28 days after each vaccination
Primary outcome [4] 0 0
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
Assessment method [4] 0 0
: Number of participants with SAEs and AESIs
Timepoint [4] 0 0
Throughout study, approximately 6 months
Primary outcome [5] 0 0
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Assessment method [5] 0 0
: Number of participants with out-of-range biological tests
Timepoint [5] 0 0
Through 7 days after vaccination
Primary outcome [6] 0 0
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
Assessment method [6] 0 0
Timepoint [6] 0 0
Day 1 and Day 29
Primary outcome [7] 0 0
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Assessment method [7] 0 0
Timepoint [7] 0 0
Day 1 and Day 29
Secondary outcome [1] 0 0
RSV B and hMPV A nAb titers at Day 1 and Day 29
Assessment method [1] 0 0
Timepoint [1] 0 0
Day 1 and Day 29
Secondary outcome [2] 0 0
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Assessment method [2] 0 0
Timepoint [2] 0 0
Day 29

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical - Herston
Recruitment hospital [3] 0 0
University of Sunshine Coast Clinical Trials - Morayfield
Recruitment hospital [4] 0 0
University of Sunshine Coast Clinical Trials - South Brisbane
Recruitment hospital [5] 0 0
Griffith University - Southport
Recruitment hospital [6] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
4506 - Morayfield
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sanofi Trial Transparency Email Recommended (Toll free for US
Address 0 0
Country 0 0
Phone 0 0
800-633-1610 ext Opt. 6
Email 0 0
contact-us@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06850051