Clinical trial NCT05513391: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
Official title: Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 366
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.

Detailed description: Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.

Eligibility criteria: Inclusion Criteria:

* Aged 3 to 8 years on the day of inclusion
* Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations

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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination
timeFrame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
measure: Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination
timeFrame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
Secondary outcomes:
measure: GMTs of Influenza Vaccine Antibodies at Day 1
timeFrame: Pre-vaccination on Day 1
measure: Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination
timeFrame: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
measure: Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
timeFrame: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
measure: Number of Participants With Immediate Unsolicited Adverse Events (AEs)
timeFrame: Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated)
measure: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
timeFrame: Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated)
measure: Number of Participants With Unsolicited AEs
timeFrame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
measure: Number of Participants With Medically Attended Adverse Events (MAAEs)
timeFrame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
measure: Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
timeFrame: From the first vaccination up to 6 months after the last vaccination, 209 days
Other outcomes:
Locations:
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 Pediatrics / Adult Research Site Number : 8400010
state: Kentucky
city: New Orleans
country: United States
facility: Velocity Clinical Research- New Orleans Site Number : 8400012
state: Louisiana
city: Lincoln
country: United States
facility: Velocity Clinical Research Lincoln Site Number : 8400013
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 Site Number : 8400022
state: South Carolina
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: Syracuse
country: United States
facility: Alliance for Multispecialty Research Syracuse Site Number : 8400027
state: Utah
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: 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: Warszawa
country: Poland
facility: Investigational Site Number : 6160001
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160012
city: Madrid
country: Spain
facility: Investigational Site Number : 7240014
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Investigational Site Number : 7240004
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: