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 Taiwanese Adults 65 Years of Age and Older

NCT04537234 | Completed Phase 3 Results

• 2 other identifiers: QHD00023U1111-1238-1970
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 4

Brief Summary

Primary Objective: Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants. Safety: To describe the safety profile of all participants in each study groups.

Conditions

Influenza (Healthy Volunteers)

Keywords

Influenza

Outcome Measures

Primary Outcomes (10)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0

  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 0 (pre-vaccination)

• Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28

  GMTs of anti-influenza antibodies were measured using 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)

• Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies

  GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).

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

• Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens

  Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28.

  Day 28 (post-vaccination)

• Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0

  Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).

  Day 0 (pre-vaccination)

• Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28

  Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).

  Day 28 (post-vaccination)

• Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

  An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

  Within 30 minutes post-vaccination

• Number of Participants With Solicited Injection Site and Systemic Reactions

  A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.

  Within 7 days post-vaccination

• Number of Participants With Unsolicited Adverse Events

  An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.

  Within 28 days post-vaccination

• Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)

  An SAE was any untoward medical occurrence 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 an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

  From Day 0 up to 28 days post-vaccination

Study Arms (2)

Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)

EXPERIMENTAL

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

Biological: High-Dose Quadrivalent Influenza Vaccine

Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)

ACTIVE COMPARATOR

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

Biological: Standard-Dose Quadrivalent Influenza Vaccine

Interventions

High-Dose Quadrivalent Influenza Vaccine BIOLOGICAL

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

Also known as: Fluzone® High Dose, Efluelda™

Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)

Standard-Dose Quadrivalent Influenza Vaccine BIOLOGICAL

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

Also known as: AdimFlu-S (QIS)

Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2.
• Previous vaccination against influenza (in the preceding 6 months) with either the study 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 vaccine(s) used in the study or to a vaccine containing any of the same substances.
• Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to \[\>=\] 38.0 degree Celsius). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• 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).
• 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 (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study.
• 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 (4)

Investigational Site Number 1580004

Taichung, 40447, Taiwan

Location

Investigational Site Number 1580001

Taipei, 100, Taiwan

Location

Investigational Site Number 1580002

Taipei, 112, Taiwan

Location

Investigational Site Number 1580003

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Chen JY, Hsieh SM, Hwang SJ, Liu CS, Li X, Fournier M, Yeh TY, Yin JK, Samson SI. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study. Vaccine. 2022 Oct 26;40(45):6450-6454. doi: 10.1016/j.vaccine.2022.09.078. Epub 2022 Oct 7.

  PMID: 36216650 DERIVED

Related Links

• QHD00023 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

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  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: The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 3, 2020
• Study Start: November 10, 2020
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: September 24, 2025
• Results First Posted: November 8, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TW (4)