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 Japanese Adults 60 Years of Age and Older

NCT04498832 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: EFC15150U1111-1225-1085QHD00010
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 10

Brief Summary

Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective:

• To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants.
• To describe the safety profile of all participants in each study group.

Conditions

Influenza Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28

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

  Day 28 (post-vaccination)

• Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis

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

  Day 28 (post-vaccination)

Secondary Outcomes (8)

• GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28

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

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

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

• Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens

  Day 28 (post-vaccination)

• Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens

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

• Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)

  Within 30 minutes post-vaccination

Study Arms (2)

Group 1: QIV-HD

EXPERIMENTAL

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

Biological: High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)

Group 2: QIV-SD

ACTIVE COMPARATOR

Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.

Biological: Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)

Interventions

High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) BIOLOGICAL

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

Also known as: QIV-HD

Group 1: QIV-HD

Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) BIOLOGICAL

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

Also known as: QIV-SD

Group 2: QIV-SD

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 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 present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 02.
• 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 eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
• Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment.
• Alcohol 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 study conduct or completion.
• 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, 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 is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for \>=5 years).
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>=37.5 degree Celsius). A prospective participant was not be included in the study until the condition had resolved or the febrile event had subsided.
• History of convulsions.
• Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (10)

Investigational Site Number 3920005

Fukuoka, Japan

Location

Investigational Site Number 3920004

Koganeishi, Japan

Location

Investigational Site Number 3920006

Kumamoto, Japan

Location

Investigational Site Number 3920001

Osaka, Japan

Location

Investigational Site Number 3920003

Shinjuku-Ku, Japan

Location

Investigational Site Number 3920008

Shinjuku-Ku, Japan

Location

Investigational Site Number 3920009

Shinjuku-Ku, Japan

Location

Investigational Site Number 3920002

Suita-Shi, Japan

Location

Investigational Site Number 3920007

Toshima-Ku, Japan

Location

Investigational Site Number 3920010

Yokohama, Japan

Location

Related Publications (1)

• Sanchez L, Nakama T, Nagai H, Matsuoka O, Inoue S, Inoue T, Shrestha A, Pandey A, Chang LJ, De Bruijn I; QHD00010 Study Group. Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults >/= 60 years of age: Results from a phase III, randomized clinical trial. Vaccine. 2023 Apr 6;41(15):2553-2561. doi: 10.1016/j.vaccine.2023.02.071. Epub 2023 Mar 10.

  PMID: 36906404 BACKGROUND

Related Links

• EFC15150 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: Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants randomized in each group were stratified by site and age (60 to 64, 65 to 74, and 75 years of age and older).

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: October 21, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: September 23, 2025
• Results First Posted: February 8, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (10)