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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05829356




Registration number
NCT05829356
Ethics application status
Date submitted
6/04/2023
Date registered
25/04/2023

Titles & IDs
Public title
Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above
Scientific title
A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of One Monovalent Modified Influenza mRNA Vaccine Encapsulated in LNP, in Adults Aged 18 to 49 Years and 60 Years and Above.
Secondary ID [1] 0 0
U1111-1278-3835
Secondary ID [2] 0 0
VAV00019
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - H3 mRNA / LNP Vaccine
Treatment: Other - Quadrivalent recombinant influenza Vaccine (RIV4)

Experimental: Group 1: H3 mRNA /LNP dose 1 - Participants will receive one intramuscular (IM) dose of H3 mRNA/LNP at Day 01

Experimental: Group 2: H3 mRNA /LNP dose 2 - Participants will receive one IM dose of H3 mRNA/LNP at Day 01

Experimental: Group 3: H3 mRNA /LNP dose 3 - Participants will receive one IM dose of H3 mRNA/LNP at Day 01

Experimental: Group 4: H3 mRNA /LNP dose 4 - Participants will receive one IM dose of H3 mRNA/LNP at Day 01

Experimental: Group 5: H3 mRNA /LNP dose 5 - Participants will receive one IM dose of H3 mRNA/LNP at Day 01

Active comparator: Group 6 (Control Group): RIV4 dose - Participants will receive one IM dose of RIV4 at Day 01


Treatment: Other: H3 mRNA / LNP Vaccine
Pharmaceutical Form: Suspension for injection

Route of Administration: Intra-Muscular

Treatment: Other: Quadrivalent recombinant influenza Vaccine (RIV4)
Pharmaceutical Form: Solution for injection in a pre-filled syringe

Route of Administration: Intra-Muscular
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with immediate adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after vaccination
Primary outcome [2] 0 0
Number of participants with solicited injection site or systemic reaction
Timepoint [2] 0 0
Within 7 days from vaccination
Primary outcome [3] 0 0
Number of participants with unsolicited adverse events
Timepoint [3] 0 0
Up to 28 days after injection
Primary outcome [4] 0 0
Presence of out-of-range biological test results
Timepoint [4] 0 0
At Day 3, Day 9 or Day 29
Primary outcome [5] 0 0
Presence of serious adverse events (SAEs)
Timepoint [5] 0 0
Throughout Study (up to approximately Month 6)
Primary outcome [6] 0 0
Presence of adverse events of special interest (AESIs)
Timepoint [6] 0 0
Throughout Study (up to approximately Month 6)
Primary outcome [7] 0 0
Hemagglutination inhibition (HAI) antibody (Ab) response to homologous strain
Timepoint [7] 0 0
Day 29
Primary outcome [8] 0 0
HAI titers at D01
Timepoint [8] 0 0
Day 1
Primary outcome [9] 0 0
HAI titers at D29
Timepoint [9] 0 0
Day 29
Primary outcome [10] 0 0
Individual HAI Ab titer ratio
Timepoint [10] 0 0
Day 1 through Day 29
Primary outcome [11] 0 0
Number of Participants with Vaccine Response or Seroconversion
Timepoint [11] 0 0
Day 1 through Day 29
Primary outcome [12] 0 0
2-fold and 4-fold rise in HAI titers from D01 to D29
Timepoint [12] 0 0
Day 1 to Day 29
Primary outcome [13] 0 0
Percentage of participants with detectable antibody HAI titers greater than or equal to (=) 40 [1/dil]
Timepoint [13] 0 0
Day 29
Primary outcome [14] 0 0
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers at Day 1
Timepoint [14] 0 0
Day 1
Primary outcome [15] 0 0
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers at Day 29
Timepoint [15] 0 0
Day 29
Primary outcome [16] 0 0
Individual nab titer ratio
Timepoint [16] 0 0
Day 1 through Day 29
Primary outcome [17] 0 0
2-fold and 4-fold increase in neutralizing Ab titers from D01 to D29
Timepoint [17] 0 0
Day 1 to Day 29

Eligibility
Key inclusion criteria
* Aged 18 years and above on the day of inclusion

*Aged 18 years to 49 years or 60 years and above on the day of inclusion (substudy 01)
* 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) at the screening visit.
* Inclusion Criteria to be Checked at Visit 1 (Day 1)

Participants are eligible for the study only if all of the following criteria are met:

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 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
* Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
* Any screening laboratory parameter with laboratory abnormalities that are greater than Grade 1 or deemed clinically significant in the opinion of the Investigator

* OR, any screening Liver Function Test (ALT, AST, Bilirubin) > 1.2x Upper Limit of Normal or any other screening laboratory parameter outside of the range of normal limits for age and gender
* Positive test for human immunodeficiency virus (HIV) antigen and/or antibodies (Abs), hepatitis B (HB) virus surface antigen (HBsAg), hepatitis B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs)
* 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 [PEG], 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 COVID-19 vaccine
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Screening electrocardiogram (ECG) or troponin value that is consistent with probable or possible myocarditis, pericarditis, and/or myopericarditis or screening ECG that demonstrates clinically relevant abnormalities that may affect participant safety or study results
* Self-reported thrombocytopenia, contraindicating intramuscular vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular 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
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Receipt of any vaccine in the 4 weeks preceding study enrollment or planned receipt of any vaccine in the 4 weeks following study intervention administration
* Receipt of any mRNA vaccine/product in the 2 months preceding study enrollment or planned receipt of any mRNA vaccine/product within the 2 months following study intervention administration
* Receipt of immune globulins, blood or blood-derived products in the past 3 months -Participation at the time of study enrollment (or in the 4 weeks preceding study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
* Exclusion criteria to be checked at Visit 1 Day 1:

* Moderate or severe acute illness/infection (according to Investigator's judgment) 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.

The above information is not intended to contain all considerations relevant to a 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2024
Sample size
Target
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360004 - Herston
Recruitment hospital [2] 0 0
Investigational Site Number : 0360001 - Morayfield
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Camberwell
Recruitment hospital [4] 0 0
Investigational Site Number : 0360003 - Adelaide
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
4506 - Morayfield
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Leicestershire
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London, City Of
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Sheffield

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
Clinical Sciences & Operations
Address 0 0
Sanofi Pasteur, a Sanofi Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT05829356