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

Last updated: July 1, 2024
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Terminated

Phase

3

Condition

N/A

Treatment

Recombinant influenza vaccine (RIV4)

Quadrivalent influenza vaccine (IIV4)

Quadrivalent influenza vaccine (IIV4) season/2022-2023/NH

Clinical Study ID

NCT05513391
VAP00026
VAP00026
U1111-1256-8841
2022-000576-19
  • Ages 3-8
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 3 to 8 years on the day of inclusion

  • Assent form has been signed and dated by the participant (according to localregulations), and informed consent form has been signed and dated by the parent(s)or another legally acceptable representative and by an independent witness, ifrequired by local regulations

Exclusion

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency, or receipt ofimmunosuppressive 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 3months)

  • Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccines used in the trial or to a vaccinecontaining 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 ofthe Investigator), neurologic disorder, or seizure disorder NOTE: The aboveinformation is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial

Study Design

Total Participants: 366
Treatment Group(s): 4
Primary Treatment: Recombinant influenza vaccine (RIV4)
Phase: 3
Study Start date:
November 10, 2022
Estimated Completion Date:
October 03, 2023

Study Description

Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.

Connect with a study center

  • Investigational Site Number : 2080005

    Aalborg, 9000
    Denmark

    Site Not Available

  • Investigational Site Number : 2080004

    Herning, 7400
    Denmark

    Site Not Available

  • Investigational Site Number :2080004

    Herning, 7400
    Denmark

    Active - Recruiting

  • Investigational Site Number : 6160007

    Bydgoszcz, Kujawsko-pomorskie 85-079
    Poland

    Site Not Available

  • Investigational Site Number : 6160010

    Bydgoszcz, Kujawsko-pomorskie 85-048
    Poland

    Site Not Available

  • Investigational Site Number :6160007

    Bydgoszcz, Kujawsko-pomorskie 85-079
    Poland

    Active - Recruiting

  • Investigational Site Number :6160010

    Bydgoszcz, Kujawsko-pomorskie 85-048
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160011

    Białystok, Podlaskie 15-430
    Poland

    Site Not Available

  • Investigational Site Number :6160011

    Białystok, Podlaskie 15-430
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160005

    Siemianowice Śląskie, Slaskie 41-103
    Poland

    Site Not Available

  • Investigational Site Number :6160005

    Siemianowice Śląskie, Slaskie 41-103
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160003

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • Investigational Site Number :6160003

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160006

    Tarnow, 33-100
    Poland

    Site Not Available

  • Investigational Site Number :6160006

    Tarnow, 33-100
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160008

    Warsaw, 02-637
    Poland

    Site Not Available

  • Investigational Site Number :6160008

    Warsaw, 02-637
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160001

    Warszawa, 02-647
    Poland

    Site Not Available

  • Investigational Site Number :6160001

    Warszawa, 02-647
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160012

    Wroclaw, 53-149
    Poland

    Site Not Available

  • Investigational Site Number :6160012

    Wroclaw, 53-149
    Poland

    Active - Recruiting

  • Investigational Site Number : 7240017

    Santiago de Compostela, A Coruña [La Coruña] 15706
    Spain

    Site Not Available

  • Investigational Site Number :7240017

    Santiago de Compostela, A Coruña [La Coruña] 15706
    Spain

    Active - Recruiting

  • Investigational Site Number :7240007

    Sevilla, Andalucia 41013
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240008

    Badalona, Catalunya [Cataluña] 08916
    Spain

    Site Not Available

  • Investigational Site Number :7240008

    Badalona, Catalunya [Cataluña] 08916
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240014

    Madrid, Madrid, Comunidad De 28046
    Spain

    Site Not Available

  • Investigational Site Number :7240004

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • Investigational Site Number :7240014

    Madrid, Madrid, Comunidad De 28046
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240004

    Madrid, 28041
    Spain

    Site Not Available

  • Investigational Site Number : 7240018

    Madrid, 28660
    Spain

    Site Not Available

  • Investigational Site Number : 7240019

    Madrid, 28050
    Spain

    Site Not Available

  • Investigational Site Number :7240018

    Madrid, 28660
    Spain

    Active - Recruiting

  • Investigational Site Number :7240019

    Madrid, 28050
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240003

    Majadahonda, 28222
    Spain

    Site Not Available

  • Investigational Site Number :7240003

    Majadahonda, 28222
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240005

    Malaga, 29015
    Spain

    Site Not Available

  • Investigational Site Number :7240005

    Malaga, 29015
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Móstoles, 28938
    Spain

    Site Not Available

  • Investigational Site Number :7240001

    Móstoles, 28938
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240007

    Sevilla, 41014
    Spain

    Site Not Available

  • Investigational Site Number : 7240013

    Valencia, 46024
    Spain

    Site Not Available

  • Investigational Site Number :7240013

    Valencia, 46024
    Spain

    Active - Recruiting

  • Birmingham Pediatric Associates Site Number : 8400023

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Birmingham Pediatric Associates-Site Number:8400023

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

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

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

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

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • California Research Foundation Site Number : 8400003

    San Diego, California 92123-1881
    United States

    Site Not Available

  • California Research Foundation-Site Number:8400003

    San Diego, California 92123-1881
    United States

    Active - Recruiting

  • Meridian Clinical Research- Sioux City Site Number : 8400007

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Meridian Clinical Research- Sioux City-Site Number:8400007

    Sioux City, Iowa 51106
    United States

    Active - Recruiting

  • AMR - Newton Site Number : 8400021

    Newton, Kansas 67114
    United States

    Site Not Available

  • AMR - Newton-Site Number:8400021

    Newton, Kansas 67114
    United States

    Active - Recruiting

  • Kentucky Pediatrics / Adult Research Site Number : 8400010

    Bardstown, Kentucky 40004
    United States

    Site Not Available

  • Kentucky Pediatrics / Adult Research-Site Number:8400010

    Bardstown, Kentucky 40004
    United States

    Active - Recruiting

  • MedPharmics-Site Number:8400012

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Velocity Clinical Research Site Number : 8400012

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Velocity Clinical Research- New Orleans Site Number : 8400012

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Meridian Research-Site Number:8400013

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Velocity Clinical Research Lincoln Site Number : 8400013

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Meridian Clinical Research-Site Number:8400009

    Omaha, Nebraska 68134
    United States

    Active - Recruiting

  • Velocity Clinical Research Omaha Site Number : 8400009

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Velocity Clinical Research, Omaha Site Number : 8400009

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Meridian Clinical Research Site Number : 8400006

    Binghamton, New York 13905
    United States

    Site Not Available

  • Meridian Clinical Research-Site Number:8400006

    Binghamton, New York 13905
    United States

    Active - Recruiting

  • Meridian Clinical Research Vestal-Site Number:8400016

    Vestal, New York 13850
    United States

    Active - Recruiting

  • Velocity Clinical Research Vestal Site Number : 8400016

    Vestal, New York 13850
    United States

    Site Not Available

  • Ohio Pediatric Research Site Number : 8400020

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Ohio Pediatric Research-Site Number:8400020

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • Rainbow Pediatrics Site Number : 8400014

    Barnwell, South Carolina 29812
    United States

    Site Not Available

  • Rainbow Pediatrics-Site Number:8400014

    Barnwell, South Carolina 29812
    United States

    Active - Recruiting

  • Coastal Pediatric Research Charleston Site Number : 8400005

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Coastal Pediatric Research Charleston-Site Number:8400005

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Coastal Carolina Research Center Site Number : 8400022

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Coastal Carolina Research Center-Site Number:8400022

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • J. Lewis Research Site Number : 8400017

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • J. Lewis Research-Site Number:8400017

    Salt Lake City, Utah 84109
    United States

    Active - Recruiting

  • JBR Clinical Research Site Number : 8400001

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • JBR Clinical Research-Site Number:8400001

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research Syracuse Site Number : 8400027

    Syracuse, Utah 84075-9645
    United States

    Site Not Available

  • Alliance for Multispecialty Research Syracuse-Site Number:8400027

    Syracuse, Utah 84075-9645
    United States

    Active - Recruiting

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