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InfluenzaPhase 1NCT06507553

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

A Phase 1 study testing Trivalent-Darwin influenza vaccine, Augment-Tasmania influenza vaccine and TIV-2X Darwin influenza vaccine in people with Influenza and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 10 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Healthy Volunteers
What is being tested?
Trivalent-Darwin influenza vaccine, Augment-Tasmania influenza vaccine and TIV-2X Darwin influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
10 sitesAustralia
Study dates
12 Aug 2024to 4 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Australia10 sites

  • Investigational Site Number : 0360007

    Adelaide, South Australia, 5067

  • Investigational Site Number : 0360002

    Botany, New South Wales, 2019

  • Investigational Site Number : 0360010

    Brookvale, New South Wales, 2100

  • Investigational Site Number : 0360012

    Maroubra, New South Wales, 2035

  • Investigational Site Number : 0360001

    Melbourne, Victoria, 3124

  • Investigational Site Number : 0360011

    Miranda, New South Wales, 2228

  • Investigational Site Number : 0360005

    Morayfield, 4506

  • Investigational Site Number : 0360004

    Sippy Downs, Queensland, 4556

  • Investigational Site Number : 0360003

    Southport, Queensland, 4222

  • Investigational Site Number : 0360013

    Taringa, Queensland, 4068

Other trials in Australia

About this study

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 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.

Being tested
Trivalent-Darwin influenza vaccine, Augment-Tasmania influenza vaccine, TIV-2X Darwin influenza vaccine, Trivalent-Tasmania influenza vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trivalent-Darwin influenza vaccineBiological

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

  • Augment-Tasmania influenza vaccineBiological

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

  • TIV-2X Darwin influenza vaccineBiological

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

  • Trivalent-Tasmania influenza vaccineBiological

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

Study groups in NCT06507553
Study groupRoleWhat they receive
Group 1 (Stage 1)Active comparatorTrivalent-Darwin standard dose (SD) formulation will be administered in a single injection to participants aged 18 to 49 years old
Receives: Biological: Trivalent-Darwin influenza vaccine
Group 2 (Stage 1)ExperimentalAugment-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old
Receives: Biological: Augment-Tasmania influenza vaccine
Group 3 (Stage 1)ExperimentalTIV-2X Darwin SD formulation will be administered in a single injection to participants aged 18 to 49 years old
Receives: Biological: TIV-2X Darwin influenza vaccine
Group 4 (Stage 1)ExperimentalTrivalent-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old
Receives: Biological: Trivalent-Tasmania influenza vaccine
Group 5 (Stage 2)Active comparatorTrivalent-Darwin high dose (HD) formulation will be administered in a single injection to participants of 60 years and older
Receives: Biological: Trivalent-Darwin influenza vaccine
Group 6 (Stage 2)ExperimentalAugment-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older
Receives: Biological: Augment-Tasmania influenza vaccine
Group 7 (Stage 2)ExperimentalTIV-2X Darwin HD formulation will be administered in a single injection to participants of 60 years and older
Receives: Biological: TIV-2X Darwin influenza vaccine
Group 8 (Stage 2)ExperimentalTrivalent-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older
Receives: Biological: Trivalent-Tasmania influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 30 minutes after vaccination

  2. Number of participants with solicited injection site reactions

    Adverse reactions prelisted in the participant diary

    Measured: Within 7 days after vaccination

  3. Number of participants with solicited systemic reactions

    Adverse reactions prelisted in the participant diary

    Measured: Within 7 days after vaccination

  4. Number of participants with unsolicited adverse events

    Adverse events other than solicited reactions

    Measured: Throughout the study, approximately 3 weeks

  5. Number of participants with serious adverse events

    SAEs occurring throughout the study

    Measured: Throughout the study, approximately 3 weeks

  6. Number of participants with adverse events of special interest (AESIs)

    AESIs occurring throughout the study

    Measured: Throughout the study, approximately 3 weeks

Secondary outcomes (8)

  1. Seroconversion based on hemagglutination inhibition antibody titer

    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)

    Measured: Day 1 and day 22

  2. Seroprotection based on hemagglutination inhibition antibody titer

    Seroprotection (HAI Ab titer ≥ 40 [1/dilution])

    Measured: Day 1 and day 22

  3. Obtained hemagglutination inhibition antibody titers

    Assessment of hemagglutination inhibition (HAI) antibody (Ab) titers obtained on day 1 and day 22 after vaccination

    Measured: Day 1 and day 22

  4. Obtained virus neutralization antibody titers

    Assessment of virus neutralization (VN) antibody (Ab) titers obtained on day 1 and day 22 after vaccination

    Measured: Day 1 and day 22

  5. Individual hemagglutination inhibition titers ratio

    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)

    Measured: Day 1 and day 22

  6. Individual virus neutralization titers ratio

    Individual VN titers ratio (day 22/ day 1)

    Measured: Day 1 and day 22

  7. 2-fold rise in virus neutralization titers

    Measured: From day 1 to day 22

  8. 4-fold rise in virus neutralization titers

    Measured: From day 1 to day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start12 Aug 2024
  3. Primary completion4 Mar 2025
  4. Study completion4 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06507553
Sponsor's protocol ID
FBP00005
Other IDs
U1111-1299-2000
Status last verified
Sep 2025
First submitted
11 Jul 2024
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Trivalent-Darwin influenza vaccine, Augment-Tasmania influenza vaccine and TIV-2X Darwin influenza vaccine in people with Influenza and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 10 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with immediate adverse event (time frame: Within 30 minutes after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06507553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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