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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06507553




Registration number
NCT06507553
Ethics application status
Date submitted
11/07/2024
Date registered
18/07/2024

Titles & IDs
Public title
Study of Influenza Vaccines Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older
Scientific title
A Translational Phase I, Randomized, Parallel-group, Multi-arm Study to Evaluate Safety and Immunogenicity of an Influenza Vaccine Formulation Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older.
Secondary ID [1] 0 0
FBP00005
Secondary ID [2] 0 0
FBP00005
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-Darwin influenza vaccine
Treatment: Other - Augment-Tasmania influenza vaccine
Treatment: Other - TIV-2X Darwin influenza vaccine
Treatment: Other - Trivalent-Tasmania influenza vaccine

Active comparator: Group 1 (Stage 1) - Trivalent-Darwin standard dose (SD) formulation will be administered in a single injection to participants aged 18 to 49 years old

Experimental: Group 2 (Stage 1) - Augment-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old

Experimental: Group 3 (Stage 1) - TIV-2X Darwin SD formulation will be administered in a single injection to participants aged 18 to 49 years old

Experimental: Group 4 (Stage 1) - Trivalent-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old

Active comparator: Group 5 (Stage 2) - Trivalent-Darwin high dose (HD) formulation will be administered in a single injection to participants of 60 years and older

Experimental: Group 6 (Stage 2) - Augment-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older

Experimental: Group 7 (Stage 2) - TIV-2X Darwin HD formulation will be administered in a single injection to participants of 60 years and older

Experimental: Group 8 (Stage 2) - Trivalent-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older


Treatment: Other: Trivalent-Darwin influenza vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Treatment: Other: Augment-Tasmania influenza vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Treatment: Other: TIV-2X Darwin influenza vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Treatment: Other: Trivalent-Tasmania influenza vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with immediate adverse event
Timepoint [1] 0 0
Within 30 minutes after vaccination
Primary outcome [2] 0 0
Number of participants with solicited injection site reactions
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Number of participants with solicited systemic reactions
Timepoint [3] 0 0
Within 7 days after vaccination
Primary outcome [4] 0 0
Number of participants with unsolicited adverse events
Timepoint [4] 0 0
Throughout the study, approximately 3 weeks
Primary outcome [5] 0 0
Number of participants with serious adverse events
Timepoint [5] 0 0
Throughout the study, approximately 3 weeks
Primary outcome [6] 0 0
Number of participants with adverse events of special interest (AESIs)
Timepoint [6] 0 0
Throughout the study, approximately 3 weeks
Secondary outcome [1] 0 0
Seroconversion based on hemagglutination inhibition antibody titer
Timepoint [1] 0 0
Day 1 and day 22
Secondary outcome [2] 0 0
Seroprotection based on hemagglutination inhibition antibody titer
Timepoint [2] 0 0
Day 1 and day 22
Secondary outcome [3] 0 0
Obtained hemagglutination inhibition antibody titers
Timepoint [3] 0 0
Day 1 and day 22
Secondary outcome [4] 0 0
Obtained virus neutralization antibody titers
Timepoint [4] 0 0
Day 1 and day 22
Secondary outcome [5] 0 0
Individual hemagglutination inhibition titers ratio
Timepoint [5] 0 0
Day 1 and day 22
Secondary outcome [6] 0 0
Individual virus neutralization titers ratio
Timepoint [6] 0 0
Day 1 and day 22
Secondary outcome [7] 0 0
2-fold rise in virus neutralization titers
Timepoint [7] 0 0
From day 1 to day 22
Secondary outcome [8] 0 0
4-fold rise in virus neutralization titers
Timepoint [8] 0 0
From day 1 to day 22

Eligibility
Key inclusion criteria
* Aged 18 to 49 years (Stage 1) or 60 years of age and older (Stage 2) on the day of inclusion
* Participants who are healthy as determined by medical evaluation including medical history and physical examination, if deemed necessary
* 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 from at least 4 weeks prior to study intervention administration until at least 3 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) before the first dose of study intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

* 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)
* History of clinically- or laboratory-confirmed diagnosis of influenza infection in the last 12 months
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, 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 judgment) or febrile illness (temperature = 38.0°C) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Self-reported or prior documented seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C
* Body mass index of 40 or higher
* Current or past diagnosis, personal or in the family, of Guillain-Barré syndrome
* Have known or recently active (within 12 months) neoplastic disease or a current or past diagnosis of any hematologic malignancy
* Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 3 weeks (approximately 21 days, or until the end of study participation) following study intervention administration
* Previous vaccination against influenza (in the year 2024) with an investigational or marketed vaccine
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Any change in chronic prescription medication or change in medication dose or dosage in the 60 days prior to enrollment

The above information is not intended to contain all considerations relevant to a participant'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
12/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/02/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360002 - Botany
Recruitment hospital [2] 0 0
Investigational Site Number : 0360010 - Brookvale
Recruitment hospital [3] 0 0
Investigational Site Number : 0360012 - Maroubra
Recruitment hospital [4] 0 0
Investigational Site Number : 0360011 - Miranda
Recruitment hospital [5] 0 0
Investigational Site Number : 0360004 - Sippy Downs
Recruitment hospital [6] 0 0
Investigational Site Number : 0360003 - Southport
Recruitment hospital [7] 0 0
Investigational Site Number : 0360013 - Taringa
Recruitment hospital [8] 0 0
Investigational Site Number : 0360007 - Norwood
Recruitment hospital [9] 0 0
Investigational Site Number : 0360001 - Camberwell
Recruitment hospital [10] 0 0
Investigational Site Number : 0360005 - Morayfield
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2228 - Miranda
Recruitment postcode(s) [5] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [6] 0 0
4222 - Southport
Recruitment postcode(s) [7] 0 0
4068 - Taringa
Recruitment postcode(s) [8] 0 0
5067 - Norwood
Recruitment postcode(s) [9] 0 0
3124 - Camberwell
Recruitment postcode(s) [10] 0 0
4506 - Morayfield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
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
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
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/NCT06507553