Status:
COMPLETED
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
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study FBP00005 is planned to be a translational Phase I, randomized, modified double-blind, active-controlled, multi-center study to be conducted in 2 stages in approximately 400 adults, 18 to 49 year...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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. In the case of adults ≥ 60 years of age (Stage 2 of the study), previous vaccination within 6 months' time period will apply.
- 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.
Key Trial Info
Start Date :
August 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06507553
Start Date
August 12 2024
End Date
March 4 2025
Last Update
September 11 2025
Active Locations (10)
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1
Investigational Site Number : 0360002
Botany, New South Wales, Australia, 2019
2
Investigational Site Number : 0360010
Brookvale, New South Wales, Australia, 2100
3
Investigational Site Number : 0360012
Maroubra, New South Wales, Australia, 2035
4
Investigational Site Number : 0360011
Miranda, New South Wales, Australia, 2228