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Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

Primary Purpose

Influenza Immunization

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Immunization

Eligibility Criteria

9 Years - 49 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 9 to 49 years on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1) Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) Is of childbearing potential and agrees 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 has been signed and dated by the participant (based on local regulations), and if applicable informed consent form has 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Alabama Clinical Therapeutics North Tower-Site Number:8400024
  • Birmingham Pediatric Associates-Site Number:8400023
  • The Children's Clinic Of Jonesboro PA-Site Number:8400025
  • California Research Foundation-Site Number:8400003
  • Meridian Clinical Research- Sioux City-Site Number:8400007
  • AMR - Newton-Site Number:8400021
  • Kentucky Pediatics / Adult Research-Site Number:8400010
  • MedPharmics-Site Number:8400012
  • Meridian Research-Site Number:8400013
  • Meridian Clinical Research Norfolk-Site Number:8400011
  • Meridian Clinical Research-Site Number:8400009
  • Meridian Clinical Research-Site Number:8400006
  • Meridian Clinical Research Vestal-Site Number:8400016
  • Ohio Pediatric Research-Site Number:8400020
  • Rainbow Pediatrics-Site Number:8400014
  • Coastal Pediatric Research Charleston-Site Number:8400005
  • Coastal Carolina Research Center - N Charleston-Site Number:8400022
  • Benchmark Research - Austin-Site Number:8400004
  • JBR Clinical Research-Site Number:8400001
  • J. Lewis Research-Site Number:8400017
  • Meridian Clinical Research Portsmouth-Site Number:8400015
  • Investigational Site Number :2030003
  • Investigational Site Number :2030001
  • Investigational Site Number :2030002
  • Investigational Site Number :2080004
  • Investigational Site Number :2080002
  • Investigational Site Number :2080006
  • Investigational Site Number :6160010
  • Investigational Site Number :6160007
  • Investigational Site Number :6160004
  • Investigational Site Number :6160011
  • Investigational Site Number :6160005
  • Investigational Site Number :6160003
  • Investigational Site Number :6160006
  • Investigational Site Number :6160008
  • Investigational Site Number :6160001
  • Investigational Site Number :6160012
  • Investigational Site Number :7240007
  • Investigational Site Number :7240006
  • Investigational Site Number :7240008
  • Investigational Site Number :7240017
  • Investigational Site Number :7240004
  • Investigational Site Number :7240014
  • Investigational Site Number :7240018
  • Investigational Site Number :7240005
  • Investigational Site Number :7240001
  • Investigational Site Number :7240013

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 9 to 17 years old

Group 18 to 49 years old

Arm Description

Participants of 9 to 17 years old who will receive RIV4 single intramuscular (IM) injection at D01

Participants of 18 to 49 years old who will receive RIV4 single intramuscular (IM) injection at D01

Outcomes

Primary Outcome Measures

Individual Hemagglutination inhibition (HAI) titer at D29 after vaccination
Geometric Mean Titers (GMTs) of RIV4 in participants aged 9 to 17 years and participants aged 18 to 49 years
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 a pre-vaccination titer ≥ 10 [1/dil] at D1 and a ≥ 4-fold increase in post-vaccination titer at D29

Secondary Outcome Measures

Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination
Antibody titers are expressed as GMTs at baseline and post-baseline
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

First Posted
August 22, 2022
Last Updated
September 27, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05513053
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
November 9, 2023 (Anticipated)
Study Completion Date
November 9, 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-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 will be approximately 6 months for each participant.

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
None (Open Label)
Allocation
Non-Randomized
Enrollment
1323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 9 to 17 years old
Arm Type
Experimental
Arm Description
Participants of 9 to 17 years old who will receive RIV4 single intramuscular (IM) injection at D01
Arm Title
Group 18 to 49 years old
Arm Type
Experimental
Arm Description
Participants of 18 to 49 years old who will receive RIV4 single intramuscular (IM) injection at D01
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Other Intervention Name(s)
Supemtek / Flublok Quadrivalent
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: intramuscular
Primary Outcome Measure Information:
Title
Individual Hemagglutination inhibition (HAI) titer at D29 after vaccination
Description
Geometric Mean Titers (GMTs) of RIV4 in participants aged 9 to 17 years and participants aged 18 to 49 years
Time Frame
Day 29 (28 days after vaccination)
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 a pre-vaccination titer ≥ 10 [1/dil] at D1 and a ≥ 4-fold increase in post-vaccination titer at D29
Time Frame
Day 29 (28 days after vaccination)
Secondary Outcome Measure Information:
Title
Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination
Description
Antibody titers are expressed as GMTs at baseline and post-baseline
Time Frame
Day 1 and Day 29 (28 days after vaccination)
Title
Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
Time Frame
Day 1 and Day 29 (28 days after vaccination)
Title
Percentage of participants with antibody titers greater than or equal to (≥) 40 [1/dil]
Time Frame
Day 1 and Day 29 (28 days after vaccination)
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 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 vaccination
Title
Occurrence of unsolicited AEs
Description
AEs that other than solicited reactions
Time Frame
Up to 28 days after vaccination
Title
Occurrence of attended adverse event (MAAEs)
Time Frame
Up to 28 days after 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
9 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 9 to 49 years on the day of inclusion A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1) Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) Is of childbearing potential and agrees 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 has been signed and dated by the participant (based on local regulations), and if applicable informed consent form has 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Alabama Clinical Therapeutics North Tower-Site Number:8400024
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Birmingham Pediatric Associates-Site Number:8400023
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
The Children's Clinic Of Jonesboro PA-Site Number:8400025
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
California Research Foundation-Site Number:8400003
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
Meridian Clinical Research- Sioux City-Site Number:8400007
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
AMR - Newton-Site Number:8400021
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Kentucky Pediatics / Adult Research-Site Number:8400010
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
MedPharmics-Site Number:8400012
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Meridian Research-Site Number:8400013
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Meridian Clinical Research Norfolk-Site Number:8400011
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400009
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400006
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Meridian Clinical Research Vestal-Site Number:8400016
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Ohio Pediatric Research-Site Number:8400020
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Rainbow Pediatrics-Site Number:8400014
City
Barnwell
State/Province
South Carolina
ZIP/Postal Code
29812
Country
United States
Facility Name
Coastal Pediatric Research Charleston-Site Number:8400005
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Coastal Carolina Research Center - N Charleston-Site Number:8400022
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Benchmark Research - Austin-Site Number:8400004
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
JBR Clinical Research-Site Number:8400001
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
J. Lewis Research-Site Number:8400017
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Meridian Clinical Research Portsmouth-Site Number:8400015
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23703
Country
United States
Facility Name
Investigational Site Number :2030003
City
Hradec Králové
ZIP/Postal Code
50002
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Jindrichuv Hradec
ZIP/Postal Code
37701
Country
Czechia
Facility Name
Investigational Site Number :2030002
City
Týnec nad Sázavou
ZIP/Postal Code
25741
Country
Czechia
Facility Name
Investigational Site Number :2080004
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Investigational Site Number :2080002
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Investigational Site Number :2080006
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Investigational Site Number :6160010
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Investigational Site Number :6160007
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Investigational Site Number :6160004
City
PuÅ'awy
State/Province
Lubuskie
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Investigational Site Number :6160011
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Investigational Site Number :6160005
City
Siemianowice Śląskie
State/Province
Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
Investigational Site Number :6160003
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Investigational Site Number :6160006
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Investigational Site Number :6160008
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Investigational Site Number :6160001
City
Warszawa
ZIP/Postal Code
02-647
Country
Poland
Facility Name
Investigational Site Number :6160012
City
Wroclaw
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Investigational Site Number :7240007
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Investigational Site Number :7240006
City
Centelles
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08540
Country
Spain
Facility Name
Investigational Site Number :7240008
City
Badalona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Investigational Site Number :7240017
City
Santiago De Compostela
State/Province
Galicia [Galicia]
ZIP/Postal Code
15706
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Facility Name
Investigational Site Number :7240014
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number :7240018
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Malaga
ZIP/Postal Code
29015
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Móstoles
ZIP/Postal Code
28938
Country
Spain
Facility Name
Investigational Site Number :7240013
City
Valencia
ZIP/Postal Code
46024
Country
Spain

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) in Participants 9 Through 49 Years of Age.

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