Clinical trial NCT04024228: 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
Official title: Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza Immunization
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 1539
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized in each group were stratified by age (60 to 64 years of age; 65 years of age and older).
Primary purpose: PREVENTION

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).

Detailed description: Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, an end of study visit and safety follow-up telephone call approximately at Day 28 and Day 180 after vaccination, respectively.

Eligibility criteria: Inclusion criteria :

* Sixty years of age and older on the day of inclusion.
* Able to attend all scheduled visits and complied with all trial procedures.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
timeFrame: Day 28 post-vaccination
Secondary outcomes:
measure: Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution)
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution)
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens
timeFrame: Day 28 post-vaccination
measure: Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
timeFrame: Within 30 minutes post-vaccination
measure: Number of Participants Reporting Solicited Injection Site Reactions
timeFrame: Within 7 days post-vaccination
measure: Number of Participants Reporting Solicited Systemic Reactions
timeFrame: Within 7 days post-vaccination
measure: Number of Participants Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 28 days post-vaccination
measure: Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
timeFrame: From Day 0 up to 6 months post-vaccination
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Investigational Site Number 0560001
city: Wilrijk
country: Belgium
facility: Investigational Site Number 0560002
city: Gieres
country: France
facility: Investigational Site Number 2500001
city: Paris
country: France
facility: Investigational Site Number 2500004
city: Pierre Benite Cedex
country: France
facility: Investigational Site Number 2500003
city: Berlin
country: Germany
facility: Investigational Site Number 2760003
city: Berlin
country: Germany
facility: Investigational Site Number 2760005
city: Berlin
country: Germany
facility: Investigational Site Number 2760004
city: Essen
country: Germany
facility: Investigational Site Number 2760001
city: Oldenburg In Holstein
country: Germany
facility: Investigational Site Number 2760002
city: Genova
country: Italy
facility: Investigational Site Number 3800001
city: Palermo
country: Italy
facility: Investigational Site Number 3800003
city: Utrecht
country: Netherlands
facility: Investigational Site Number 5280001
city: Debica
country: Poland
facility: Investigational Site Number 6160001
city: Siemianowice Slaskie
country: Poland
facility: Investigational Site Number 6160003
city: Wola
country: Poland
facility: Investigational Site Number 6160002
city: Wroclaw
country: Poland
facility: Investigational Site Number 6160004
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: