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

NCT06507553 | Completed Phase 1

• 2 other identifiers: FBP00005U1111-1299-2000
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 10

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.

Conditions

Influenza; Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Number of participants with immediate adverse event

  Includes unsolicited systemic adverse events (or) medically relevant unsolicited systemic adverse events, including those related to the product administered

  Within 30 minutes after vaccination

• Number of participants with solicited injection site reactions

  Adverse reactions prelisted in the participant diary

  Within 7 days after vaccination

• Number of participants with solicited systemic reactions

  Adverse reactions prelisted in the participant diary

  Within 7 days after vaccination

• Number of participants with unsolicited adverse events

  Adverse events other than solicited reactions

  Throughout the study, approximately 3 weeks

• Number of participants with serious adverse events

  SAEs occurring throughout the study

  Throughout the study, approximately 3 weeks

• Number of participants with adverse events of special interest (AESIs)

  AESIs occurring throughout the study

  Throughout the study, approximately 3 weeks

Secondary Outcomes (8)

• Seroconversion based on hemagglutination inhibition antibody titer

  Day 1 and day 22

• Seroprotection based on hemagglutination inhibition antibody titer

  Day 1 and day 22

• Obtained hemagglutination inhibition antibody titers

  Day 1 and day 22

• Obtained virus neutralization antibody titers

  Day 1 and day 22

• Individual hemagglutination inhibition titers ratio

  Day 1 and day 22

Study Arms (8)

Group 1 (Stage 1)

ACTIVE COMPARATOR

Trivalent-Darwin standard dose (SD) formulation will be administered in a single injection to participants aged 18 to 49 years old

Biological: Trivalent-Darwin influenza vaccine

Group 2 (Stage 1)

EXPERIMENTAL

Augment-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old

Biological: Augment-Tasmania influenza vaccine

Group 3 (Stage 1)

EXPERIMENTAL

TIV-2X Darwin SD formulation will be administered in a single injection to participants aged 18 to 49 years old

Biological: TIV-2X Darwin influenza vaccine

Group 4 (Stage 1)

EXPERIMENTAL

Trivalent-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old

Biological: Trivalent-Tasmania influenza vaccine

Group 5 (Stage 2)

ACTIVE COMPARATOR

Trivalent-Darwin high dose (HD) formulation will be administered in a single injection to participants of 60 years and older

Biological: Trivalent-Darwin influenza vaccine

Group 6 (Stage 2)

EXPERIMENTAL

Augment-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older

Biological: Augment-Tasmania influenza vaccine

Group 7 (Stage 2)

EXPERIMENTAL

TIV-2X Darwin HD formulation will be administered in a single injection to participants of 60 years and older

Biological: TIV-2X Darwin influenza vaccine

Group 8 (Stage 2)

EXPERIMENTAL

Trivalent-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older

Biological: Trivalent-Tasmania influenza vaccine

Interventions

Trivalent-Darwin influenza vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Group 1 (Stage 1); Group 5 (Stage 2)

Augment-Tasmania influenza vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Group 2 (Stage 1); Group 6 (Stage 2)

TIV-2X Darwin influenza vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Group 3 (Stage 1); Group 7 (Stage 2)

Trivalent-Tasmania influenza vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Group 4 (Stage 1); Group 8 (Stage 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (10)

Investigational Site Number : 0360002

Botany, New South Wales, 2019, Australia

Location

Investigational Site Number : 0360010

Brookvale, New South Wales, 2100, Australia

Location

Investigational Site Number : 0360012

Maroubra, New South Wales, 2035, Australia

Location

Investigational Site Number : 0360011

Miranda, New South Wales, 2228, Australia

Location

Investigational Site Number : 0360004

Sippy Downs, Queensland, 4556, Australia

Location

Investigational Site Number : 0360003

Southport, Queensland, 4222, Australia

Location

Investigational Site Number : 0360013

Taringa, Queensland, 4068, Australia

Location

Investigational Site Number : 0360007

Adelaide, South Australia, 5067, Australia

Location

Investigational Site Number : 0360001

Melbourne, Victoria, 3124, Australia

Location

Investigational Site Number : 0360005

Morayfield, 4506, Australia

Location

Related Links

• FBP00005 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double-blind (observer-blind; blinded for participants and sites, except for those preparing/administering study intervention, and for the Sponsor, except for dedicated Sponsor staff who will be unblinded for interim analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: August 12, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (10)