Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

NCT05513391 | Terminated Phase 3 Results FDA Drug

• 3 other identifiers: VAP00026U1111-1256-88412022-000576-19
• Study Type: interventional
• Target: 366
• Locations: 3 countries
• Sites: 31

Brief Summary

The purpose of this study was 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.

Conditions

Influenza Immunization

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination

  GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.

  Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]

• Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination

  Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer.

  Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]

Secondary Outcomes (8)

• GMTs of Influenza Vaccine Antibodies at Day 1

  Pre-vaccination on Day 1

• Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination

  Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)

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

  Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)

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

  Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated)

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

  Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated)

Study Arms (2)

RIV4 cohort

EXPERIMENTAL

RIV4 single injection at Day 1

Biological: Recombinant influenza vaccine (RIV4)

IIV4 cohort

ACTIVE COMPARATOR

IIV4, single injection at Day 1

Biological: Quadrivalent influenza vaccine (IIV4)

Interventions

Recombinant influenza vaccine (RIV4) BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: intramuscular

Also known as: Supemtek / Flublok Quadrivalent

RIV4 cohort

Quadrivalent influenza vaccine (IIV4) BIOLOGICAL

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Also known as: Fluarix Tetra / Fluarix® Quadrivalent

IIV4 cohort

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

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 is 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 (31)

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 Pediatrics / Adult Research Site Number : 8400010

Bardstown, Kentucky, 40004, United States

Location

Velocity Clinical Research- New Orleans Site Number : 8400012

New Orleans, Louisiana, 70119, United States

Location

Velocity Clinical Research Lincoln Site Number : 8400013

Lincoln, Nebraska, 68510, 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 Site Number : 8400022

North Charleston, South Carolina, 29405, 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

Alliance for Multispecialty Research Syracuse Site Number : 8400027

Syracuse, Utah, 84075-9645, United States

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 : 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 : 6160001

Warsaw, 02-647, Poland

Location

Investigational Site Number : 6160012

Wroclaw, 53-149, Poland

Location

Investigational Site Number : 7240014

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Investigational Site Number : 7240004

Madrid, 28041, 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 Links

• VAP00026 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double-blind (participant, Sponsor, and Investigator blinded)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: November 10, 2022
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: September 9, 2025
• Results First Posted: July 24, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (7); US (18); ES (6)