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

Phase 3

Completed

Conditions: Healthy Volunteers
Influenza Immunization

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

Registration Number: NCT04498832

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description: Study duration per participant was approximately 28 days including: 1 day of screening and vaccination, a safety follow-up telephone call and an end of study visit approximately at Day 8 and 28 after vaccination, respectively.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: QIV-SD	Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)	Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
Group 1: QIV-HD	High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)	Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis	Day 28 (post-vaccination)	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.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28	Day 28 (post-vaccination)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens	Day 28 (post-vaccination)	Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer \<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.
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28	Day 0 (pre-vaccination) and Day 28 (post-vaccination)	GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens	Day 0 (pre-vaccination), Day 28 (post-vaccination)	Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) is reported in the outcome measure.
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies	Day 0 (pre-vaccination), Day 28 (post-vaccination)	GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)	Within 30 minutes post-vaccination	An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual 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 AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Number of Participants Reporting Unsolicited Adverse Events (AEs)	Within 28 days post-vaccination	An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual 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.
Number of Participants Reporting Solicited Injection Site and Systemic Reactions	Within 7 days post-vaccination	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 CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Number of Participants Reporting Serious Adverse Events (SAEs)	From Day 0 up to Day 28 post-vaccination	A 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.

Trial Locations

Locations (10): Investigational Site Number 3920002
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Suita-Shi, Japan
Investigational Site Number 3920007
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Toshima-Ku, Japan
Investigational Site Number 3920005
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Fukuoka-Shi, Japan
Investigational Site Number 3920008
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Shinjuku-Ku, Japan
Investigational Site Number 3920009
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Shinjuku-Ku, Japan
Investigational Site Number 3920010
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Yokohama-Shi, Japan
Investigational Site Number 3920004
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Koganei-Shi, Japan
Investigational Site Number 3920003
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Shinjuku-Ku, Japan
Investigational Site Number 3920006
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Kumamoto-Shi, Japan
Investigational Site Number 3920001
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Osaka-Shi, Japan