Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

NCT04024228 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: QHD000112019-000655-14U1111-1225-0952
• Study Type: interventional
• Target: 1,539
• Locations: 6 countries
• Sites: 17

Brief Summary

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective:

• Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
• Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

Conditions

Influenza Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years

  GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.

  Day 28 post-vaccination

Secondary Outcomes (13)

• Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution)

  Day 28 post-vaccination

Study Arms (2)

Group 1: QIV-HD

EXPERIMENTAL

Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.

Biological: High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation

Group 2: QIV-SD

ACTIVE COMPARATOR

Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.

Biological: Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)

Interventions

Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD) BIOLOGICAL

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

Also known as: Influvac™ Tetra

Group 2: QIV-SD

High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation BIOLOGICAL

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

Group 1: QIV-HD

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to attend all scheduled visits and complied with all trial procedures.

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential and did not used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
• Participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 02.
• Previous vaccination against influenza (in the previous 6 months) with either the trial vaccine or another vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• 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).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
• Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement.
• Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the trial conduct or completion.
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
• Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature greater than or equal to (\>=) 38.0 degree Celsius) on the day of vaccination. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
• 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.
• Personal or family history of Guillain Barré syndrome.
• Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for \>= 5 years)
• The above information was 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 (17)

Investigational Site Number 0560001

Ghent, BE-9000, Belgium

Location

Investigational Site Number 0560002

Wilrijk, 2610, Belgium

Location

Investigational Site Number 2500001

Gières, 38610, France

Location

Investigational Site Number 2500004

Paris, 75014, France

Location

Investigational Site Number 2500003

Pierre-Bénite, 69495, France

Location

Investigational Site Number 2760003

Berlin, 10629, Germany

Location

Investigational Site Number 2760005

Berlin, 10787, Germany

Location

Investigational Site Number 2760004

Berlin, 13347, Germany

Location

Investigational Site Number 2760001

Essen, 45136, Germany

Location

Investigational Site Number 2760002

Oldenburg in Holstein, 23758, Germany

Location

Investigational Site Number 3800001

Genova, IT-16132, Italy

Location

Investigational Site Number 3800003

Palermo, 90127, Italy

Location

Investigational Site Number 5280001

Utrecht, 3584 CX, Netherlands

Location

Investigational Site Number 6160001

Dębica, 39-200, Poland

Location

Investigational Site Number 6160003

Siemianowice Śląskie, 41-103, Poland

Location

Investigational Site Number 6160002

Wola, 43-225, Poland

Location

Investigational Site Number 6160004

Wroclaw, 50-452, Poland

Location

Related Links

• QHD00011 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Hemagglutinins; Neuraminidase; Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Agglutinins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Coagulants; Hematologic Agents; Therapeutic Uses; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: the participant and the Investigators remained unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but were not involved in the immunogenicity and safety evaluations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants randomized in each group were stratified by age (60 to 64 years of age; 65 years of age and older).

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: October 28, 2019
• Primary Completion: January 9, 2020
• Study Completion: June 5, 2020
• Last Updated: September 12, 2025
• Results First Posted: January 19, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); NL (1); IT (2); DE (5); PL (4); BE (2)