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
- Conditions
- Healthy VolunteersInfluenza
- Interventions
- Biological: Trivalent-Darwin influenza vaccineBiological: TIV-2X Darwin influenza vaccineBiological: Augment-Tasmania influenza vaccineBiological: Trivalent-Tasmania influenza vaccine
- Registration Number
- NCT06507553
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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 years of age and ≥ 60 years of age, in Australia. The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain, compared to formulations containing a single strain from each influenza virus subtype.
Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose. Adults ≥ 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose.
Enrollment of participants in Stage 2 will occur after review of, and be guided by, safety and immunogenicity results from Stage 1. The study duration will be approximately 3 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
-
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 5 (Stage 2) Trivalent-Darwin influenza vaccine Trivalent-Darwin high dose (HD) formulation will be administered in a single injection to participants of 60 years and older Group 7 (Stage 2) TIV-2X Darwin influenza vaccine TIV-2X Darwin HD formulation will be administered in a single injection to participants of 60 years and older Group 2 (Stage 1) Augment-Tasmania influenza vaccine Augment-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old Group 3 (Stage 1) TIV-2X Darwin influenza vaccine TIV-2X Darwin SD formulation will be administered in a single injection to participants aged 18 to 49 years old Group 1 (Stage 1) Trivalent-Darwin influenza vaccine Trivalent-Darwin standard dose (SD) formulation will be administered in a single injection to participants aged 18 to 49 years old Group 8 (Stage 2) Trivalent-Tasmania influenza vaccine Trivalent-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older Group 6 (Stage 2) Augment-Tasmania influenza vaccine Augment-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older Group 4 (Stage 1) Trivalent-Tasmania influenza vaccine Trivalent-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old
- Primary Outcome Measures
Name Time Method Number of participants with adverse events of special interest (AESIs) Throughout the study, approximately 3 weeks AESIs occurring throughout the study
Number of participants with unsolicited adverse events Throughout the study, approximately 3 weeks Adverse events other than solicited reactions
Number of participants with immediate adverse event Within 30 minutes after vaccination Includes unsolicited systemic adverse events (or) medically relevant unsolicited systemic adverse events, including those related to the product administered
Number of participants with solicited systemic reactions Within 7 days after vaccination Adverse reactions prelisted in the participant diary
Number of participants with serious adverse events Throughout the study, approximately 3 weeks SAEs occurring throughout the study
Number of participants with solicited injection site reactions Within 7 days after vaccination Adverse reactions prelisted in the participant diary
- Secondary Outcome Measures
Name Time Method Seroconversion based on hemagglutination inhibition antibody titer Day 1 and day 22 Seroconversion (HAI Ab titer \< 10 \[1/dilution\] at day 1 and post-injection titer ≥ 40 \[1/dilution\] at day 22, or titer ≥ 10 \[1/dilution\] at day 1 and a ≥ 4-fold increase in titer \[1/dilution\] at day 22)
Seroprotection based on hemagglutination inhibition antibody titer Day 1 and day 22 Seroprotection (HAI Ab titer ≥ 40 \[1/dilution\])
Individual hemagglutination inhibition titers ratio Day 1 and day 22 Seroconversion (HAI Ab titer \< 10 \[1/dilution\] at day 1 and post-injection titer ≥ 40 \[1/dilution\] at day 22, or titer ≥ 10 \[1/dilution\] at day 1 and a ≥ 4-fold increase in titer \[1/dilution\] at day 22)
Individual virus neutralization titers ratio Day 1 and day 22 Individual VN titers ratio (day 22/ day 1)
4-fold rise in virus neutralization titers From day 1 to day 22 2-fold rise in virus neutralization titers From day 1 to day 22 Obtained hemagglutination inhibition antibody titers Day 1 and day 22 Assessment of hemagglutination inhibition (HAI) antibody (Ab) titers obtained on day 1 and day 22 after vaccination
Obtained virus neutralization antibody titers Day 1 and day 22 Assessment of virus neutralization (VN) antibody (Ab) titers obtained on day 1 and day 22 after vaccination
Trial Locations
- Locations (10)
Investigational Site Number : 0360002
🇦🇺Botany, New South Wales, Australia
Investigational Site Number : 0360010
🇦🇺Brookvale, New South Wales, Australia
Investigational Site Number : 0360011
🇦🇺Miranda, New South Wales, Australia
Investigational Site Number : 0360013
🇦🇺Taringa, Queensland, Australia
Investigational Site Number : 0360004
🇦🇺Sippy Downs, Queensland, Australia
Investigational Site Number : 0360005
🇦🇺Morayfield, Australia
Investigational Site Number : 0360003
🇦🇺Southport, Queensland, Australia
Investigational Site Number : 0360007
🇦🇺Adelaide, South Australia, Australia
Investigational Site Number : 0360012
🇦🇺Maroubra, New South Wales, Australia
Investigational Site Number : 0360001
🇦🇺Melbourne, Victoria, Australia