Clinical trial NCT06507553: 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
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

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. 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.

Primary outcomes:
measure: Number of participants with immediate adverse event
timeFrame: Within 30 minutes after vaccination
measure: Number of participants with solicited injection site reactions
timeFrame: Within 7 days after vaccination
measure: Number of participants with solicited systemic reactions
timeFrame: Within 7 days after vaccination
measure: Number of participants with unsolicited adverse events
timeFrame: Throughout the study, approximately 3 weeks
measure: Number of participants with serious adverse events
timeFrame: Throughout the study, approximately 3 weeks
measure: Number of participants with adverse events of special interest (AESIs)
timeFrame: Throughout the study, approximately 3 weeks
Secondary outcomes:
measure: Seroconversion based on hemagglutination inhibition antibody titer
timeFrame: Day 1 and day 22
measure: Seroprotection based on hemagglutination inhibition antibody titer
timeFrame: Day 1 and day 22
measure: Obtained hemagglutination inhibition antibody titers
timeFrame: Day 1 and day 22
measure: Obtained virus neutralization antibody titers
timeFrame: Day 1 and day 22
measure: Individual hemagglutination inhibition titers ratio
timeFrame: Day 1 and day 22
measure: Individual virus neutralization titers ratio
timeFrame: Day 1 and day 22
measure: 2-fold rise in virus neutralization titers
timeFrame: From day 1 to day 22
measure: 4-fold rise in virus neutralization titers
timeFrame: From day 1 to day 22
Other outcomes:
Locations:
city: Botany
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: Brookvale
country: Australia
facility: Investigational Site Number : 0360010
state: New South Wales
city: Maroubra
country: Australia
facility: Investigational Site Number : 0360012
state: New South Wales
city: Miranda
country: Australia
facility: Investigational Site Number : 0360011
state: New South Wales
city: Sippy Downs
country: Australia
facility: Investigational Site Number : 0360004
state: Queensland
city: Southport
country: Australia
facility: Investigational Site Number : 0360003
state: Queensland
city: Taringa
country: Australia
facility: Investigational Site Number : 0360013
state: Queensland
city: Adelaide
country: Australia
facility: Investigational Site Number : 0360007
state: South Australia
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360001
state: Victoria
city: Morayfield
country: Australia
facility: Investigational Site Number : 0360005
Study officials:
References: