Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
NCT ID: NCT05513053
Last Updated: 2025-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1308 participants
INTERVENTIONAL
2022-10-27
2023-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 9 to 17 years old
Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01
Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Pharmaceutical form: Solution for injection Route of administration: intramuscular
Group 18 to 49 years old
Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01
Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Pharmaceutical form: Solution for injection Route of administration: intramuscular
Interventions
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Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Pharmaceutical form: Solution for injection Route of administration: intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
9 Years
49 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Alabama Clinical Therapeutics North Tower Site Number : 8400024
Birmingham, Alabama, United States
Birmingham Pediatric Associates Site Number : 8400023
Birmingham, Alabama, United States
The Children's Clinic Of Jonesboro PA Site Number : 8400025
Jonesboro, Arkansas, United States
California Research Foundation Site Number : 8400003
San Diego, California, United States
Meridian Clinical Research- Sioux City Site Number : 8400007
Sioux City, Iowa, United States
AMR - Newton Site Number : 8400021
Newton, Kansas, United States
Kentucky Pediatics / Adult Research Site Number : 8400010
Bardstown, Kentucky, United States
Velocity Clinical Research Site Number : 8400012
New Orleans, Louisiana, United States
Velocity Clinical Research Lincoln Site Number : 8400013
Lincoln, Nebraska, United States
Meridian Clinical Research Norfolk Site Number : 8400011
Norfolk, Nebraska, United States
Velocity Clinical Research, Omaha Site Number : 8400009
Omaha, Nebraska, United States
Meridian Clinical Research Site Number : 8400006
Binghamton, New York, United States
Velocity Clinical Research Vestal Site Number : 8400016
Vestal, New York, United States
Ohio Pediatric Research Site Number : 8400020
Dayton, Ohio, United States
Rainbow Pediatrics Site Number : 8400014
Barnwell, South Carolina, United States
Coastal Pediatric Research Charleston Site Number : 8400005
Charleston, South Carolina, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400022
North Charleston, South Carolina, United States
Benchmark Research - Austin Site Number : 8400004
Austin, Texas, United States
JBR Clinical Research Site Number : 8400001
Salt Lake City, Utah, United States
J. Lewis Research Site Number : 8400017
Salt Lake City, Utah, United States
Velocity Clinical Research Portsmouth Site Number : 8400015
Portsmouth, Virginia, United States
Investigational Site Number : 2030001
Jindřichův Hradec, , Czechia
Investigational Site Number : 6160010
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160007
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160004
PuÅ'awy, Lubusz Voivodeship, Poland
Investigational Site Number : 6160005
Siemianowice Śląskie, Silesian Voivodeship, Poland
Investigational Site Number : 6160003
Bydgoszcz, , Poland
Investigational Site Number : 6160006
Tarnów, , Poland
Investigational Site Number : 6160008
Warsaw, , Poland
Investigational Site Number : 6160012
Wroclaw, , Poland
Investigational Site Number : 7240006
Centelles, Barcelona [Barcelona], Spain
Investigational Site Number : 7240018
Madrid, , Spain
Investigational Site Number : 7240005
Málaga, , Spain
Investigational Site Number : 7240001
Móstoles, , Spain
Investigational Site Number : 7240007
Seville, , Spain
Countries
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References
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Folegatti PM, Pepin S, Tabar C, Fries K, Talanova O, See S, Essink B, Bertoch T, Drazan D, Natalini Martinez S, Konieczny M, Kaas-Leach K, De Bruijn I. Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study. Lancet Infect Dis. 2025 Oct;25(10):1097-1105. doi: 10.1016/S1473-3099(25)00153-7. Epub 2025 May 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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VAP00027 Plain Language Results Summary
Other Identifiers
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U1111-1260-4678
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAP00027
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000577-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VAP00027
Identifier Type: -
Identifier Source: org_study_id
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