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InfluenzaPhase 3NCT06641180

Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age

A Phase 3 study testing High-Dose trivalent influenza vaccine (Split virion, Inactivated) and Standard-dose trivalent influenza vaccine (Split virion, Inactivated) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.

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

The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age. Read more about this study

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
High-Dose trivalent influenza vaccine (Split virion, Inactivated) and Standard-dose trivalent influenza vaccine (Split virion, Inactivated)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,180 participants
Where
20 sitesUnited States
Study dates
4 Nov 2024to 24 Jun 2025
Phase
Phase 3
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 50 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 50 to 64 years on the day of inclusion.
  • 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 postmenopausal for at least 1 year, or surgically sterile.
  • OR
  • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 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) at enrollment before the first dose of study intervention.
  • Informed consent form has been signed and dated.
  • Able to attend all scheduled visits and to comply with all study procedures.

Who cannot join

  • 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).
  • Personal or family history of Guillain-Barré Syndrome (GBS).
  • Known systemic hypersensitivity to any of the study intervention components (Section 1.1, Section 6.1), or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances.
  • Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment.
  • 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 15Show fewer
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) 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.
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
  • Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine prior to the second blood drawing (ie. approximately 4 weeks after the study intervention administration).
  • Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine.
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
  • Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie.
  • parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Hassman Research Institute - Berlin- Site Number : 8400006

    Berlin, New Jersey, 08009

  • IACT Health - Columbus - Talbotton Road- Site Number : 8400011

    Columbus, Georgia, 31904

  • Aventiv Research Columbus- Site Number : 8400016

    Columbus, Ohio, 43213

  • Cenexel IRA - iResearch Atlanta- Site Number : 8400007

    Decatur, Georgia, 30030

  • The Hope Clinic of Emory Vaccine Center- Site Number : 8400017

    Decatur, Georgia, 30030

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400019

    Fort Myers, Florida, 33912

  • CBH Health - Gaithersburg- Site Number : 8400004

    Gaithersburg, Maryland, 20877

  • Research Centers of America - Hollywood- Site Number : 8400010

    Hollywood, Florida, 33024

  • Alliance for Multispecialty Research - Volunteer Research Group- Site Number : 8400001

    Knoxville, Tennessee, 37920

  • Alliance for Multispeciality Research - Lexington- Site Number : 8400002

    Lexington, Kentucky, 40509

  • CenExel CNS- Site Number : 8400005

    Los Alamitos, California, 90720

  • Centricity Morehead- Site Number : 8400014

    Morehead City, North Carolina, 28557

  • Centricity New Bern- Site Number : 8400015

    New Bern, North Carolina, 28562

  • Alliance for Multispeciality Research - Newton- Site Number : 8400003

    Newton, Kansas, 67114

  • Kaiser Permanente Center for Health Research- Site Number : 8400018

    Portland, Oregon, 97227

  • Centricity Research - Rincon- Site Number : 8400012

    Rincon, Georgia, 31406

  • JBR Clinical Research- Site Number : 8400009

    Salt Lake City, Utah, 84107

  • Cenexel IRS - iResearch Savannah- Site Number : 8400008

    Savannah, Georgia, 31405

  • Kaiser Permanente Washington- Site Number : 8400024

    Seattle, Washington, 98101

  • Centricity Research - Suffolk Primary Care - Centricity - PPDS- Site Number : 8400013

    Suffolk, Virginia, 23435-3763

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Modified Double-blind, 2-arm Study to Evaluate the Immunogenicity and Safety of High-Dose Inactivated Influenza Vaccine (IIV-HD) Compared With a Standard-dose Inactivated Influenza Vaccine (IIV-SD) in Participants 50 Through 64 Years of Age.

The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.

Read the detailed description

The study duration will be approximately 180 days (+ 14 days).

Conditions
Influenza
Being tested
High-Dose trivalent influenza vaccine (Split virion, Inactivated), Standard-dose trivalent influenza vaccine (Split virion, Inactivated)
Medical subject headings
Influenza, Human

What participants receive

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

  • High-Dose trivalent influenza vaccine (Split virion, Inactivated)Biological

    Liquid suspension for intramuscular injection

  • Standard-dose trivalent influenza vaccine (Split virion, Inactivated)Biological

    Liquid suspension for intramuscular injection

Study groups in NCT06641180
Study groupRoleWhat they receive
IIV-HDExperimentalParticipants will receive a single intramuscular (IM) injection of IIV-HD at Day 1
Receives: Biological: High-Dose trivalent influenza vaccine (Split virion, Inactivated)
IIV-SDActive comparatorParticipants will receive a single intramuscular (IM) injection of IIV-SD at Day 1
Receives: Biological: Standard-dose trivalent influenza vaccine (Split virion, Inactivated)

What is being measured

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

  1. Geometric mean titers (GMTs) against influenza vaccine antibodies (Ab)

    GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage.

    Measured: Day 1 and Day 29

  2. Percentage of participants with seroconversion for influenza vaccine antibodies

    Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Seroconversion status 28 days after vaccination (ie, preinjection Ab titer < 10 [1/dil] at Day 1 and post-injection Ab titer≥ 40 [1/dil] at Day 29 or preinjection Ab titer ≥ 10 [1/dil] at Day 1 and a ≥ 4-fold increase in titer [1/dil] at Day 29).

    Measured: Day 29

Secondary outcomes (10)

  1. Geometric Mean of Individual Titer Ratio (GMTR)

    GMTRs will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Individual HAI antibody titer ratio Day 29/Day 1.

    Measured: Day 1 and Day 29

  2. Percentage of participants with detectable HAI titer (HAI titer ≥ 10 [1/dil])

    Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Percentage of participants with HAI antibody titer >=10 (1/dil)

    Measured: Day 1 and Day 29

  3. Percentage of participants with HAI titer ≥ 40 (1/dil)

    Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Percentage of participants with HAI antibody titers ≥ 40 (1/dil)

    Measured: Day 29

  4. Number of participants with immediate adverse events (AEs)

    Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.

    Measured: Within 30 minutes after vaccination

  5. Number of participants with solicited injection site reactions

    Solicited injection site reactions (pre-listed in the participant diary and CRF)

    Measured: Up to 7 days after vaccination

  6. Number of participants with solicited systemic reaction

    Solicited systemic reactions (pre-listed in the participant diary and CRF)

    Measured: Up to 7 days after vaccination

  7. Number of participants with unsolicited AEs

    An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, ie, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.

    Measured: Up to 28 days after vaccination

  8. Number of participants with medically attended adverse events (MAAEs)

    An MAAE is a new-onset or a worsening of a condition that prompts the participant or participant's parent(s)/legally acceptable representative(s) to seek unplanned medical advice at a physician's office or Emergency Department.

    Measured: Throughout the study, approximately 180 days

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

    An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate.

    Measured: Throughout the study, approximately 180 days

  10. Number of participants with serious adverse events (SAEs)

    A SAE is defined as any adverse event that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was other medically important event.

    Measured: Throughout the study, approximately 180 days

Timeline

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

  1. First posted15 Oct 2024
  2. Study start4 Nov 2024
  3. Primary completion28 Jan 2025
  4. Study completion24 Jun 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06641180
Sponsor's protocol ID
QHD00042
Other IDs
U1111-1305-7370
Status last verified
Dec 2025
First submitted
11 Oct 2024
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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 3 study testing High-Dose trivalent influenza vaccine (Split virion, Inactivated) and Standard-dose trivalent influenza vaccine (Split virion, Inactivated) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.

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 8 inclusion and 15 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Geometric mean titers (GMTs) against influenza vaccine antibodies (Ab) (time frame: Day 1 and Day 29). The study lists 2 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 NCT06641180.

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 3 Dec 2025.

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