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

NCT ID: NCT05513391

Last Updated: 2025-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-10-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza Immunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Modified double-blind (participant, Sponsor, and Investigator blinded)

Study Groups

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RIV4 cohort

RIV4 single injection at Day 1

Group Type EXPERIMENTAL

Recombinant influenza vaccine (RIV4)

Intervention Type BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: intramuscular

IIV4 cohort

IIV4, single injection at Day 1

Group Type ACTIVE_COMPARATOR

Quadrivalent influenza vaccine (IIV4)

Intervention Type BIOLOGICAL

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Interventions

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Recombinant influenza vaccine (RIV4)

Pharmaceutical form: solution for injection Route of administration: intramuscular

Intervention Type BIOLOGICAL

Quadrivalent influenza vaccine (IIV4)

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Supemtek / Flublok Quadrivalent Fluarix Tetra / Fluarix® Quadrivalent

Eligibility Criteria

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Inclusion Criteria

* Aged 3 to 8 years on the day of inclusion
* 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

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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

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Birmingham Pediatric Associates Site Number : 8400023

Birmingham, Alabama, United States

Site Status

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

Jonesboro, Arkansas, United States

Site Status

California Research Foundation Site Number : 8400003

San Diego, California, United States

Site Status

Meridian Clinical Research- Sioux City Site Number : 8400007

Sioux City, Iowa, United States

Site Status

AMR - Newton Site Number : 8400021

Newton, Kansas, United States

Site Status

Kentucky Pediatrics / Adult Research Site Number : 8400010

Bardstown, Kentucky, United States

Site Status

Velocity Clinical Research- New Orleans Site Number : 8400012

New Orleans, Louisiana, United States

Site Status

Velocity Clinical Research Lincoln Site Number : 8400013

Lincoln, Nebraska, United States

Site Status

Velocity Clinical Research Omaha Site Number : 8400009

Omaha, Nebraska, United States

Site Status

Meridian Clinical Research Site Number : 8400006

Binghamton, New York, United States

Site Status

Velocity Clinical Research Vestal Site Number : 8400016

Vestal, New York, United States

Site Status

Ohio Pediatric Research Site Number : 8400020

Dayton, Ohio, United States

Site Status

Rainbow Pediatrics Site Number : 8400014

Barnwell, South Carolina, United States

Site Status

Coastal Pediatric Research Charleston Site Number : 8400005

Charleston, South Carolina, United States

Site Status

Coastal Carolina Research Center Site Number : 8400022

North Charleston, South Carolina, United States

Site Status

JBR Clinical Research Site Number : 8400001

Salt Lake City, Utah, United States

Site Status

J. Lewis Research Site Number : 8400017

Salt Lake City, Utah, United States

Site Status

Alliance for Multispecialty Research Syracuse Site Number : 8400027

Syracuse, Utah, United States

Site Status

Investigational Site Number : 6160010

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6160007

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6160005

Siemianowice Śląskie, Silesian Voivodeship, Poland

Site Status

Investigational Site Number : 6160003

Bydgoszcz, , Poland

Site Status

Investigational Site Number : 6160006

Tarnów, , Poland

Site Status

Investigational Site Number : 6160001

Warsaw, , Poland

Site Status

Investigational Site Number : 6160012

Wroclaw, , Poland

Site Status

Investigational Site Number : 7240014

Madrid, Madrid, Comunidad de, Spain

Site Status

Investigational Site Number : 7240004

Madrid, , Spain

Site Status

Investigational Site Number : 7240018

Madrid, , Spain

Site Status

Investigational Site Number : 7240005

Málaga, , Spain

Site Status

Investigational Site Number : 7240001

Móstoles, , Spain

Site Status

Investigational Site Number : 7240007

Seville, , Spain

Site Status

Countries

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United States Poland Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.trialsummaries.com/Study/StudyDetails?id=25370&tenant=MT_SNY_9011

VAP00026 Plain Language Results Summary

Other Identifiers

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U1111-1256-8841

Identifier Type: REGISTRY

Identifier Source: secondary_id

VAP00026

Identifier Type: OTHER

Identifier Source: secondary_id

2022-000576-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAP00026

Identifier Type: -

Identifier Source: org_study_id

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