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

NCT05513053 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: VAP00027U1111-1260-46782022-000577-11
• Study Type: interventional
• Target: 1,308
• Locations: 4 countries
• Sites: 35

Brief Summary

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.

Conditions

Influenza Immunization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• GMTs Against Influenza Vaccine Antibodies at Day 1

  Pre-vaccination on Day 1

• Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29

  On Days 1 and 29

• Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies

  On Days 1 and 29

• Number of Participants With Immediate Unsolicited Adverse Events (AEs)

  Within 30 minutes post-vaccination on Day 1

• Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

  From Day 1 up to 7 days post-vaccination (up to Day 8)

Study Arms (2)

Group 9 to 17 years old

EXPERIMENTAL

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

Group 18 to 49 years old

EXPERIMENTAL

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

Interventions

Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH BIOLOGICAL

Pharmaceutical form: Solution for injection Route of administration: intramuscular

Also known as: Supemtek / Flublok Quadrivalent

Group 18 to 49 years old; Group 9 to 17 years old

Eligibility Criteria

• Age: 9 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (35)

Alabama Clinical Therapeutics North Tower Site Number : 8400024

Birmingham, Alabama, 35205, United States

Location

Birmingham Pediatric Associates Site Number : 8400023

Birmingham, Alabama, 35205, United States

Location

The Children's Clinic Of Jonesboro PA Site Number : 8400025

Jonesboro, Arkansas, 72401, United States

Location

California Research Foundation Site Number : 8400003

San Diego, California, 92123-1881, United States

Location

Meridian Clinical Research- Sioux City Site Number : 8400007

Sioux City, Iowa, 51106, United States

Location

AMR - Newton Site Number : 8400021

Newton, Kansas, 67114, United States

Location

Kentucky Pediatics / Adult Research Site Number : 8400010

Bardstown, Kentucky, 40004, United States

Location

Velocity Clinical Research Site Number : 8400012

New Orleans, Louisiana, 70119, United States

Location

Velocity Clinical Research Lincoln Site Number : 8400013

Lincoln, Nebraska, 68510, United States

Location

Meridian Clinical Research Norfolk Site Number : 8400011

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research, Omaha Site Number : 8400009

Omaha, Nebraska, 68134, United States

Location

Meridian Clinical Research Site Number : 8400006

Binghamton, New York, 13905, United States

Location

Velocity Clinical Research Vestal Site Number : 8400016

Vestal, New York, 13850, United States

Location

Ohio Pediatric Research Site Number : 8400020

Dayton, Ohio, 45414, United States

Location

Rainbow Pediatrics Site Number : 8400014

Barnwell, South Carolina, 29812, United States

Location

Coastal Pediatric Research Charleston Site Number : 8400005

Charleston, South Carolina, 29414, United States

Location

Coastal Carolina Research Center - N Charleston Site Number : 8400022

North Charleston, South Carolina, 29405, United States

Location

Benchmark Research - Austin Site Number : 8400004

Austin, Texas, 78705, United States

Location

JBR Clinical Research Site Number : 8400001

Salt Lake City, Utah, 84107, United States

Location

J. Lewis Research Site Number : 8400017

Salt Lake City, Utah, 84109, United States

Location

Velocity Clinical Research Portsmouth Site Number : 8400015

Portsmouth, Virginia, 23703, United States

Location

Investigational Site Number : 2030001

Jindřichův Hradec, 37701, Czechia

Location

Investigational Site Number : 6160010

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

Location

Investigational Site Number : 6160007

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

Location

Investigational Site Number : 6160004

PuÅ'awy, Lubusz Voivodeship, 24-100, Poland

Location

Investigational Site Number : 6160005

Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

Location

Investigational Site Number : 6160003

Bydgoszcz, 85-796, Poland

Location

Investigational Site Number : 6160006

Tarnów, 33-100, Poland

Location

Investigational Site Number : 6160008

Warsaw, 02-637, Poland

Location

Investigational Site Number : 6160012

Wroclaw, 53-149, Poland

Location

Investigational Site Number : 7240006

Centelles, Barcelona [Barcelona], 08540, Spain

Location

Investigational Site Number : 7240018

Madrid, 28660, Spain

Location

Investigational Site Number : 7240005

Málaga, 29015, Spain

Location

Investigational Site Number : 7240001

Móstoles, 28938, Spain

Location

Investigational Site Number : 7240007

Seville, 41014, Spain

Location

Related Publications (1)

• 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.

  PMID: 40412421 DERIVED

Related Links

• VAP00027 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: October 27, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: September 9, 2025
• Results First Posted: May 30, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); US (21); PL (8); CZ (1)