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

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.

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.

Study Overview

• Status: Completed
• Conditions: Influenza Immunization
• Intervention / Treatment: Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH

Detailed Description

The participation duration was approximately 6 months for each participant.

• Study Type: Interventional
• Enrollment (Actual): 1308
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Jindřichův Hradec, Czechia, 37701
    • Investigational Site Number : 2030001
• Poland
  • Bydgoszcz, Poland, 85-796
    • Investigational Site Number : 6160003
  • Tarnów, Poland, 33-100
    • Investigational Site Number : 6160006
  • Warsaw, Poland, 02-637
    • Investigational Site Number : 6160008
  • Wroclaw, Poland, 53-149
    • Investigational Site Number : 6160012
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
      • Investigational Site Number : 6160010
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
      • Investigational Site Number : 6160007
  • Lubusz Voivodeship
    • PuÅ'awy, Lubusz Voivodeship, Poland, 24-100
      • Investigational Site Number : 6160004
  • Silesian Voivodeship
    • Siemianowice Śląskie, Silesian Voivodeship, Poland, 41-103
      • Investigational Site Number : 6160005
• Spain
  • Madrid, Spain, 28660
    • Investigational Site Number : 7240018
  • Málaga, Spain, 29015
    • Investigational Site Number : 7240005
  • Móstoles, Spain, 28938
    • Investigational Site Number : 7240001
  • Seville, Spain, 41014
    • Investigational Site Number : 7240007
  • Barcelona [Barcelona]
    • Centelles, Barcelona [Barcelona], Spain, 08540
      • Investigational Site Number : 7240006
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates Site Number : 8400023
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics North Tower Site Number : 8400024
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic Of Jonesboro PA Site Number : 8400025
  • California
    • San Diego, California, United States, 92123-1881
      • California Research Foundation Site Number : 8400003
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Meridian Clinical Research- Sioux City Site Number : 8400007
  • Kansas
    • Newton, Kansas, United States, 67114
      • AMR - Newton Site Number : 8400021
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatics / Adult Research Site Number : 8400010
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Velocity Clinical Research Site Number : 8400012
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Velocity Clinical Research Lincoln Site Number : 8400013
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research Norfolk Site Number : 8400011
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha Site Number : 8400009
  • New York
    • Binghamton, New York, United States, 13905
      • Meridian Clinical Research Site Number : 8400006
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research Vestal Site Number : 8400016
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Site Number : 8400020
  • South Carolina
    • Barnwell, South Carolina, United States, 29812
      • Rainbow Pediatrics Site Number : 8400014
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research Charleston Site Number : 8400005
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center - N Charleston Site Number : 8400022
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research - Austin Site Number : 8400004
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research Site Number : 8400001
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research Site Number : 8400017
  • Virginia
    • Portsmouth, Virginia, United States, 23703
      • Velocity Clinical Research Portsmouth Site Number : 8400015

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 9 to 17 years old; Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01	Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH; Pharmaceutical form: Solution for injection Route of administration: intramuscular; Other Names: Supemtek / Flublok Quadrivalent
Experimental: Group 18 to 49 years old; Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01	Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH; Pharmaceutical form: Solution for injection Route of administration: intramuscular; Other Names: Supemtek / Flublok Quadrivalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29	GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.	Day 29
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29	Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer >= 1:10 at Day 1 and a >= 4-fold increase in post-vaccination titer.	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMTs Against Influenza Vaccine Antibodies at Day 1	GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.	Pre-vaccination on Day 1
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29	Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 and >=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.	On Days 1 and 29
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies	GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.	On Days 1 and 29
Number of Participants With Immediate Unsolicited Adverse Events (AEs)	An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs.	Within 30 minutes post-vaccination on Day 1
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions	A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.	From Day 1 up to 7 days post-vaccination (up to Day 8)
Number of Participants With Unsolicited AEs	An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination.	From Day 1 up to 28 days post-vaccination (up to Day 29)
Number of Participants With Medically Attended Adverse Events (MAAEs)	An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.	From Day 1 up to 28 days post-vaccination (up to Day 29)
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)	An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.	From Day 1 up to 6 months post-vaccination, 181 days

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• 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 May 21:S1473-3099(25)00153-7. doi: 10.1016/S1473-3099(25)00153-7. Online ahead of print.

Helpful Links

• VAP00027 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: VAP00027 (Other Identifier: Sanofi Identifier); U1111-1260-4678 (Registry Identifier: ICTRP); 2022-000577-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• 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