Clinical trial NCT03282240: Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
Official title: Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 2670
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.
Primary purpose: PREVENTION

Brief summary: This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.

Detailed description: This randomized, modified double-blind, active-controlled, multi-center trial was conducted in healthy adults (greater than and equal to \[\>=\] 65 years) to assess the safety and immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain from the primary lineage (TIV-HD1; licensed vaccine \[Fluzone® High-Dose\] for the 2017-2018 Northern Hemisphere \[NH\] influenza season) or the B strain from the alternate lineage (TIV-HD2, investigational TIV-HD containing an alternate B strain).

Eligibility criteria: Inclusion Criteria:

* Aged \>= 65 years on the day of inclusion.
* Informed consent form had been signed and dated.
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation at the time of trial enrollment (or in the 4 weeks 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 2.
* Previous vaccination against influenza (in the preceding 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 judgment.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* 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.
* Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, 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 trial.
* 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 \>= 38.0°C \[\>= 100.4°F\]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event had subsided.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 28 post-vaccination
Secondary outcomes:
measure: GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 28 post-vaccination
measure: GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
timeFrame: Day 0, Day 28
measure: Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
timeFrame: Day 28
measure: Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
timeFrame: Day 0, Day 28
measure: Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
timeFrame: Within 7 days after vaccination
measure: Number of Participants With Immediate Adverse Event (AEs)
timeFrame: Within 30 minutes after vaccination
measure: Number of Participant With Unsolicited Adverse Event (AE)
timeFrame: Within 28 days after vaccination
measure: Number of Participant With Serious Adverse Event
timeFrame: Up to 6 months after vaccination
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Sanofi Pasteur Investigational Site 037
state: California
city: Redding
country: United States
facility: Sanofi Pasteur Investigational Site 029
state: California
city: San Diego
country: United States
facility: Sanofi Pasteur Investigational Site 003
state: California
city: Colorado Springs
country: United States
facility: Sanofi Pasteur Investigational Site 016
state: Colorado
city: Milford
country: United States
facility: Sanofi Pasteur Investigational Site 035
state: Connecticut
city: Hollywood
country: United States
facility: Sanofi Pasteur Investigational Site 031
state: Florida
city: Jacksonville
country: United States
facility: Sanofi Pasteur Investigational Site 009
state: Florida
city: Jacksonville
country: United States
facility: Sanofi Pasteur Investigational Site 017
state: Florida
city: Stockbridge
country: United States
facility: Sanofi Pasteur Investigational Site 030
state: Georgia
city: Boise
country: United States
facility: Sanofi Pasteur Investigational Site 010
state: Idaho
city: Meridian
country: United States
facility: Sanofi Pasteur Investigational Site 034
state: Idaho
city: Council Bluffs
country: United States
facility: Sanofi Pasteur Investigational Site 021
state: Iowa
city: Wichita
country: United States
facility: Sanofi Pasteur Investigational Site 023
state: Kansas
city: Wichita
country: United States
facility: Sanofi Pasteur Investigational Site 028
state: Kansas
city: Bardstown
country: United States
facility: Sanofi Pasteur Investigational Site 012
state: Kentucky
city: Metairie
country: United States
facility: Sanofi Pasteur Investigational Site 018
state: Louisiana
city: Biloxi
country: United States
facility: Sanofi Pasteur Investigational Site 026
state: Mississippi
city: Saint Louis
country: United States
facility: Sanofi Pasteur Investigational Site 014
state: Missouri
city: Omaha
country: United States
facility: Sanofi Pasteur Investigational Site 011
state: Nebraska
city: Las Vegas
country: United States
facility: Sanofi Pasteur Investigational Site 024
state: Nevada
city: Rochester
country: United States
facility: Sanofi Pasteur Investigational Site 008
state: New York
city: Wilmington
country: United States
facility: Sanofi Pasteur Investigational Site 005
state: North Carolina
city: Winston-Salem
country: United States
facility: Sanofi Pasteur Investigational Site 036
state: North Carolina
city: Cleveland
country: United States
facility: Sanofi Pasteur Investigational Site 004
state: Ohio
city: Oklahoma City
country: United States
facility: Sanofi Pasteur Investigational Site 015
state: Oklahoma
city: Warwick
country: United States
facility: Sanofi Pasteur Investigational Site 013
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Sanofi Pasteur Investigational Site 033
state: South Carolina
city: Nashville
country: United States
facility: Sanofi Pasteur Investigational Site 001
state: Tennessee
city: Dallas
country: United States
facility: Sanofi Pasteur Investigational Site 002
state: Texas
city: Tomball
country: United States
facility: Sanofi Pasteur Investigational Site 025
state: Texas
city: Salt Lake City
country: United States
facility: Sanofi Pasteur Investigational Site 027
state: Utah
city: Salt Lake City
country: United States
facility: Sanofi Pasteur Investigational Site 006
state: Utah
city: Salt Lake City
country: United States
facility: Sanofi Pasteur Investigational Site 019
state: Utah
city: South Jordan
country: United States
facility: Sanofi Pasteur Investigational Site 020
state: Utah
city: West Jordan
country: United States
facility: Sanofi Pasteur Investigational Site 022
state: Utah
city: Norfolk
country: United States
facility: Sanofi Pasteur Investigational Site 038
state: Virginia
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >/=65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17.