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

NCT06641180 | Completed Phase 3 FDA Drug

• 2 other identifiers: QHD00042U1111-1305-7370
• Study Type: interventional
• Target: 1,180
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1 and Day 29

• 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).

  Day 29

Secondary Outcomes (10)

• Geometric Mean of Individual Titer Ratio (GMTR)

  Day 1 and Day 29

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

  Day 1 and Day 29

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

  Day 29

• Number of participants with immediate adverse events (AEs)

  Within 30 minutes after vaccination

• Number of participants with solicited injection site reactions

  Up to 7 days after vaccination

Study Arms (2)

IIV-HD

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1

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

IIV-SD

ACTIVE COMPARATOR

Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1

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

Interventions

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

Liquid suspension for intramuscular injection

IIV-HD

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

Liquid suspension for intramuscular injection

IIV-SD

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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 \[≥ 100.4°F\]) 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (20)

CenExel CNS- Site Number : 8400005

Los Alamitos, California, 90720, United States

Location

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

Fort Myers, Florida, 33912, United States

Location

Research Centers of America - Hollywood- Site Number : 8400010

Hollywood, Florida, 33024, United States

Location

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

Columbus, Georgia, 31904, United States

Location

Cenexel IRA - iResearch Atlanta- Site Number : 8400007

Decatur, Georgia, 30030, United States

Location

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

Decatur, Georgia, 30030, United States

Location

Centricity Research - Rincon- Site Number : 8400012

Rincon, Georgia, 31406, United States

Location

Cenexel IRS - iResearch Savannah- Site Number : 8400008

Savannah, Georgia, 31405, United States

Location

Alliance for Multispeciality Research - Newton- Site Number : 8400003

Newton, Kansas, 67114, United States

Location

Alliance for Multispeciality Research - Lexington- Site Number : 8400002

Lexington, Kentucky, 40509, United States

Location

CBH Health - Gaithersburg- Site Number : 8400004

Gaithersburg, Maryland, 20877, United States

Location

Hassman Research Institute - Berlin- Site Number : 8400006

Berlin, New Jersey, 08009, United States

Location

Centricity Morehead- Site Number : 8400014

Morehead City, North Carolina, 28557, United States

Location

Centricity New Bern- Site Number : 8400015

New Bern, North Carolina, 28562, United States

Location

Aventiv Research Columbus- Site Number : 8400016

Columbus, Ohio, 43213, United States

Location

Kaiser Permanente Center for Health Research- Site Number : 8400018

Portland, Oregon, 97227, United States

Location

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

Knoxville, Tennessee, 37920, United States

Location

JBR Clinical Research- Site Number : 8400009

Salt Lake City, Utah, 84107, United States

Location

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

Suffolk, Virginia, 23435-3763, United States

Location

Kaiser Permanente Washington- Site Number : 8400024

Seattle, Washington, 98101, United States

Location

Related Links

• QHD00042 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double-blind: * Participants, Sponsor study staff\*, investigators, and study site staff will not know which study vaccine is administered during the study conduct * Dedicated study site staff who prepare/administer the study interventions and are not involved in the safety evaluation will know which study vaccine is administered. * Select sponsor staff will be unblinded after the code break for primary completion analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 4, 2024
• Primary Completion: January 28, 2025
• Study Completion: June 24, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (20)