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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06744205




Registration number
NCT06744205
Ethics application status
Date submitted
16/12/2024
Date registered
20/12/2024
Date last updated
17/01/2025

Titles & IDs
Public title
A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older
Scientific title
A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older
Secondary ID [1] 0 0
U1111-1303-3537
Secondary ID [2] 0 0
FBP00021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
Treatment: Other - TIV mRNA-neuraminidase (NA)
Treatment: Other - TIV mRNA-HA Vaccine 2
Treatment: Other - Quadrivalent Influenza Standard Dose Vaccine
Treatment: Other - Quadrivalent Influenza Vaccine High Dose

Experimental: Group 1 - Hexavalent (Combination 1) - Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1)

Experimental: Group 2 - Hexavalent (Combination 2) - Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2)

Experimental: Group 3 - Hexavalent (Combination 3) - Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3)

Experimental: Group 4 - Hexavalent (Combination 4) - Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4)

Experimental: Group 5 - Hexavalent (Combination 5) - Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5)

Experimental: Group 6 - Hexavalent (Combination 6) - Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6)

Experimental: Group 7 - TIV mRNA-HA Vaccine 1 - Participants will receive a single dose of TIV mRNA-HA Vaccine 1

Experimental: Group 8 - TIV mRNA-NA - Participants will receive a single dose of TIV mRNA-NA

Experimental: Group 9 - TIV mRNA-HA Vaccine 2 - Participants will receive single dose of TIV mRNA-HA Vaccine 2

Active comparator: Group 10 - QIV-SD - Participants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only)

Active comparator: Group 11 - QIV-HD - Participants will receive single dose of QIV-HD vaccine


Treatment: Other: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection

Treatment: Other: TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection

Treatment: Other: TIV mRNA-HA Vaccine 2
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection

Treatment: Other: Quadrivalent Influenza Standard Dose Vaccine
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe
* Route of administration: Intramuscular injection

Treatment: Other: Quadrivalent Influenza Vaccine High Dose
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe
* Route of administration: Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with immediate unsolicited systemic adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after injection
Primary outcome [2] 0 0
Number of participants with solicited injection site reactions
Timepoint [2] 0 0
Up to 7 days after injection
Primary outcome [3] 0 0
Number of participants with solicited systemic reactions
Timepoint [3] 0 0
Up to 7 days after injection
Primary outcome [4] 0 0
Number of participants with unsolicited AEs
Timepoint [4] 0 0
Up to 28 days after injection
Primary outcome [5] 0 0
Number of participants with medically attended adverse events (MAAEs)
Timepoint [5] 0 0
Up to 180 days after injection
Primary outcome [6] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [6] 0 0
SAEs throughout the study (Up to approximately 12 months)
Primary outcome [7] 0 0
Number of participants with adverse events of special interest (AESIs)
Timepoint [7] 0 0
AESIs throughout the study (Up to approximately 12 months)
Primary outcome [8] 0 0
Number of participants with out-of-range biological test results
Timepoint [8] 0 0
Up to 8 days after injection
Primary outcome [9] 0 0
Hemagglutinin inhibition (HAI) titers
Timepoint [9] 0 0
At Day 1 and Day 29
Primary outcome [10] 0 0
Individual HAI antibody (Ab) titer ratio D29/D01
Timepoint [10] 0 0
At Day 1 and Day 29
Primary outcome [11] 0 0
Seroconversion (HAI Ab titer)
Timepoint [11] 0 0
At Day 1 and Day 29
Primary outcome [12] 0 0
HAI Ab titer = 40 (1/dil)
Timepoint [12] 0 0
At Day 29
Primary outcome [13] 0 0
Neuraminidase inhibition (NAI) titers
Timepoint [13] 0 0
At Day 1 and Day 29
Primary outcome [14] 0 0
Individual NAI Ab titer ratio D29/D01
Timepoint [14] 0 0
At Day 1 and Day 29
Primary outcome [15] 0 0
Seroconversion (NAI Ab titer)
Timepoint [15] 0 0
At Day 1 and Day 29
Primary outcome [16] 0 0
NAI Ab titer = 40 (1/dil)
Timepoint [16] 0 0
At Day 29
Primary outcome [17] 0 0
2-fold and 4-fold rise in NAI titers
Timepoint [17] 0 0
Day 1 to Day 29
Secondary outcome [1] 0 0
Neutralizing antibodies titers
Timepoint [1] 0 0
At Day 1 and Day 29
Secondary outcome [2] 0 0
Individual neutralizing antibodies titer ratio
Timepoint [2] 0 0
At Day 1 and Day 29
Secondary outcome [3] 0 0
2-fold and 4-fold increase in neutralizing titers
Timepoint [3] 0 0
Day 1 to Day 29

Eligibility
Key inclusion criteria
* Participant aged 50 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 postmenopausal 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 12 weeks after study intervention administration.

A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are not eligible for the study if any of the following criteria are met:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Known history of previous episodes of Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
* Participants with an electrocardiogram that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
* Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on Investigator's judgment
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
* Moderate or severe acute illness / infection (according to investigator's judgement) or febrile illness (temperature = 38.0°C [= 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the first visit (V01)
* Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
* Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration or planned receipt of any mRNA vaccine in the 2 months after study vaccination
* Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

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
6/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
1158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Botany
Recruitment hospital [2] 0 0
Investigational Site Number : 0360003 - Bayswater
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Melbourne
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
3153 - Bayswater
Recruitment postcode(s) [3] 0 0
3124 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
Trial website
https://clinicaltrials.gov/study/NCT06744205
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06744205