Clinical trial NCT05513053: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
Official title: Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 1308
Sex: ALL
Minimum age (years): 9
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.

Detailed description: The participation duration was approximately 6 months for each participant.

Eligibility criteria: Inclusion Criteria:

* Aged 9 to 49 years on the day of inclusion
* A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
* Assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative

Exclusion Criteria:

* 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
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
* Personal or family history of Guillain-Barre Syndrome (GBS)
* Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29
timeFrame: Day 29
measure: Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29
timeFrame: Day 29
Secondary outcomes:
measure: GMTs Against Influenza Vaccine Antibodies at Day 1
timeFrame: Pre-vaccination on Day 1
measure: Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29
timeFrame: On Days 1 and 29
measure: Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
timeFrame: On Days 1 and 29
measure: Number of Participants With Immediate Unsolicited Adverse Events (AEs)
timeFrame: Within 30 minutes post-vaccination on Day 1
measure: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
timeFrame: From Day 1 up to 7 days post-vaccination (up to Day 8)
measure: Number of Participants With Unsolicited AEs
timeFrame: From Day 1 up to 28 days post-vaccination (up to Day 29)
measure: Number of Participants With Medically Attended Adverse Events (MAAEs)
timeFrame: From Day 1 up to 28 days post-vaccination (up to Day 29)
measure: Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
timeFrame: From Day 1 up to 6 months post-vaccination, 181 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics North Tower Site Number : 8400024
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates Site Number : 8400023
state: Alabama
city: Jonesboro
country: United States
facility: The Children's Clinic Of Jonesboro PA Site Number : 8400025
state: Arkansas
city: San Diego
country: United States
facility: California Research Foundation Site Number : 8400003
state: California
city: Sioux City
country: United States
facility: Meridian Clinical Research- Sioux City Site Number : 8400007
state: Iowa
city: Newton
country: United States
facility: AMR - Newton Site Number : 8400021
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatics / Adult Research Site Number : 8400010
state: Kentucky
city: New Orleans
country: United States
facility: Velocity Clinical Research Site Number : 8400012
state: Louisiana
city: Lincoln
country: United States
facility: Velocity Clinical Research Lincoln Site Number : 8400013
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research Norfolk Site Number : 8400011
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha Site Number : 8400009
state: Nebraska
city: Binghamton
country: United States
facility: Meridian Clinical Research Site Number : 8400006
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research Vestal Site Number : 8400016
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Site Number : 8400020
state: Ohio
city: Barnwell
country: United States
facility: Rainbow Pediatrics Site Number : 8400014
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research Charleston Site Number : 8400005
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - N Charleston Site Number : 8400022
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research - Austin Site Number : 8400004
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research Site Number : 8400001
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Site Number : 8400017
state: Utah
city: Portsmouth
country: United States
facility: Velocity Clinical Research Portsmouth Site Number : 8400015
state: Virginia
city: Jindrichuv Hradec
country: Czechia
facility: Investigational Site Number : 2030001
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160010
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160007
state: Kujawsko-pomorskie
city: PuÅ'awy
country: Poland
facility: Investigational Site Number : 6160004
state: Lubuskie
city: Siemianowice Śląskie
country: Poland
facility: Investigational Site Number : 6160005
state: Slaskie
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160003
city: Tarnow
country: Poland
facility: Investigational Site Number : 6160006
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160008
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160012
city: Centelles
country: Spain
facility: Investigational Site Number : 7240006
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Investigational Site Number : 7240018
city: Malaga
country: Spain
facility: Investigational Site Number : 7240005
city: Móstoles
country: Spain
facility: Investigational Site Number : 7240001
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240007
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: