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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

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
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
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
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
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
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
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
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
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
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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