Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
Primary Purpose
Influenza Immunization
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Recombinant influenza vaccine (RIV4)
Quadrivalent influenza vaccine (IIV4)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Immunization
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
Sites / Locations
- Birmingham Pediatric Associates-Site Number:8400023Recruiting
- The Children's Clinic Of Jonesboro PA-Site Number:8400025Recruiting
- California Research Foundation-Site Number:8400003Recruiting
- Meridian Clinical Research- Sioux City-Site Number:8400007Recruiting
- AMR - Newton-Site Number:8400021Recruiting
- Kentucky Pediatrics / Adult Research-Site Number:8400010Recruiting
- MedPharmics-Site Number:8400012Recruiting
- Meridian Research-Site Number:8400013Recruiting
- Meridian Clinical Research-Site Number:8400009Recruiting
- Meridian Clinical Research-Site Number:8400006Recruiting
- Meridian Clinical Research Vestal-Site Number:8400016Recruiting
- Ohio Pediatric Research-Site Number:8400020Recruiting
- Rainbow Pediatrics-Site Number:8400014Recruiting
- Coastal Pediatric Research Charleston-Site Number:8400005Recruiting
- Coastal Carolina Research Center-Site Number:8400022Recruiting
- JBR Clinical Research-Site Number:8400001Recruiting
- J. Lewis Research-Site Number:8400017Recruiting
- Alliance for Multispecialty Research Syracuse-Site Number:8400027Recruiting
- Investigational Site Number :2080004Recruiting
- Investigational Site Number :6160010Recruiting
- Investigational Site Number :6160007Recruiting
- Investigational Site Number :6160011Recruiting
- Investigational Site Number :6160005Recruiting
- Investigational Site Number :6160003Recruiting
- Investigational Site Number :6160006Recruiting
- Investigational Site Number :6160008Recruiting
- Investigational Site Number :6160001Recruiting
- Investigational Site Number :6160012Recruiting
- Investigational Site Number :7240017Recruiting
- Investigational Site Number :7240007Recruiting
- Investigational Site Number :7240008Recruiting
- Investigational Site Number :7240004Recruiting
- Investigational Site Number :7240014Recruiting
- Investigational Site Number :7240019Recruiting
- Investigational Site Number :7240018Recruiting
- Investigational Site Number :7240003Recruiting
- Investigational Site Number :7240005Recruiting
- Investigational Site Number :7240001Recruiting
- Investigational Site Number :7240013Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RIV4 cohort
IIV4 cohort
Arm Description
RIV4 single injection at Day 1
IIV4, single injection at Day 1
Outcomes
Primary Outcome Measures
Individual Hemagglutination inhibition (HAI) titer at D29 after last vaccination
Antibody titers are expressed as GMTs
Percentage of participants achieving seroconversion
Seroconversion for participants with a pre-vaccination titer lower than (<) 10 [1/dil] at D01 and a post-vaccination titer ≥ 40 [1/dil] at D29 or D57, or a pre-vaccination titer ≥ 10 [1/dil] at D1 and a ≥ 4-fold increase in post-vaccination titer at D29 or D57
Secondary Outcome Measures
Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination
Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
Percentage of participants with antibody titers greater than or equal to (≥) 40 [1/dil]
Occurrence of immediate adverse events (AEs)
Immediate adverse events include unsolicited systemic adverse events within 30 minutes after vaccination
Occurrence of solicited injection site reactions and systemic reactions
Adverse reactions pre-listed in the (electronic) case report book (CRB) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia
Occurrence of unsolicited AEs
AEs that other than solicited reactions
Occurrence of attended adverse event (MAAEs)
Occurrence of serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Full Information
NCT ID
NCT05513391
First Posted
August 22, 2022
Last Updated
August 2, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT05513391
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
October 13, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is 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 will be enrolled on the day of their first vaccination to receive 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 will be followed for 6 months after the last vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Immunization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Modified double-blind (participant, Sponsor, and Investigator blinded)
Allocation
Randomized
Enrollment
1412 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIV4 cohort
Arm Type
Experimental
Arm Description
RIV4 single injection at Day 1
Arm Title
IIV4 cohort
Arm Type
Active Comparator
Arm Description
IIV4, single injection at Day 1
Intervention Type
Biological
Intervention Name(s)
Recombinant influenza vaccine (RIV4)
Other Intervention Name(s)
Supemtek / Flublok Quadrivalent
Intervention Description
Pharmaceutical form: solution for injection Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Quadrivalent influenza vaccine (IIV4)
Other Intervention Name(s)
Fluarix Tetra / Fluarix® Quadrivalent
Intervention Description
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Primary Outcome Measure Information:
Title
Individual Hemagglutination inhibition (HAI) titer at D29 after last vaccination
Description
Antibody titers are expressed as GMTs
Time Frame
Day 29 or Day 57
Title
Percentage of participants achieving seroconversion
Description
Seroconversion for participants with a pre-vaccination titer lower than (<) 10 [1/dil] at D01 and a post-vaccination titer ≥ 40 [1/dil] at D29 or D57, or a pre-vaccination titer ≥ 10 [1/dil] at D1 and a ≥ 4-fold increase in post-vaccination titer at D29 or D57
Time Frame
Day 29 or Day 57
Secondary Outcome Measure Information:
Title
Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination
Time Frame
Day 1 and Day 29 or Day 57
Title
Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
Time Frame
Day 1 and Day 29 or Day 57
Title
Percentage of participants with antibody titers greater than or equal to (≥) 40 [1/dil]
Time Frame
Day 1 and Day 29 or Day 57
Title
Occurrence of immediate adverse events (AEs)
Description
Immediate adverse events include unsolicited systemic adverse events within 30 minutes after vaccination
Time Frame
Within 30 minutes after each vaccination
Title
Occurrence of solicited injection site reactions and systemic reactions
Description
Adverse reactions pre-listed in the (electronic) case report book (CRB) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia
Time Frame
Within 8 days after each vaccination
Title
Occurrence of unsolicited AEs
Description
AEs that other than solicited reactions
Time Frame
Up to 28 days after each vaccination
Title
Occurrence of attended adverse event (MAAEs)
Time Frame
Up to 28 days after each vaccination
Title
Occurrence of serious adverse events (SAEs)
Description
SAEs, including adverse event of special interest (AESIs)
Time Frame
From Day 1 until the EoS (up to 6 months after vaccination)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Pediatric Associates-Site Number:8400023
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
The Children's Clinic Of Jonesboro PA-Site Number:8400025
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Name
California Research Foundation-Site Number:8400003
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research- Sioux City-Site Number:8400007
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Individual Site Status
Recruiting
Facility Name
AMR - Newton-Site Number:8400021
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Individual Site Status
Recruiting
Facility Name
Kentucky Pediatrics / Adult Research-Site Number:8400010
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Individual Site Status
Recruiting
Facility Name
MedPharmics-Site Number:8400012
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Research-Site Number:8400013
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research-Site Number:8400009
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research-Site Number:8400006
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research Vestal-Site Number:8400016
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Pediatric Research-Site Number:8400020
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Name
Rainbow Pediatrics-Site Number:8400014
City
Barnwell
State/Province
South Carolina
ZIP/Postal Code
29812
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research Charleston-Site Number:8400005
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Carolina Research Center-Site Number:8400022
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Name
JBR Clinical Research-Site Number:8400001
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
J. Lewis Research-Site Number:8400017
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research Syracuse-Site Number:8400027
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075-9645
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2080004
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160010
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-048
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160007
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160011
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-430
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160005
City
Siemianowice Śląskie
State/Province
Slaskie
ZIP/Postal Code
41-103
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160003
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160006
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160008
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Warszawa
ZIP/Postal Code
02-647
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160012
City
Wroclaw
ZIP/Postal Code
53-149
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240017
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240007
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240008
City
Badalona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240014
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240019
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240018
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240005
City
Malaga
ZIP/Postal Code
29015
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Móstoles
ZIP/Postal Code
28938
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240013
City
Valencia
ZIP/Postal Code
46024
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
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