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

Phase 3TerminatedNCT05513391

Sanofi Pasteur, a Sanofi Company366 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

366

Conditions

Influenza Immunization

Interventions

Recombinant influenza vaccine (RIV4)BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: intramuscular

Quadrivalent influenza vaccine (IIV4)BIOLOGICAL

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]

Secondary Outcomes

GMTs of Influenza Vaccine Antibodies at Day 1

GMTs of influenza vaccine 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.

Time frame: 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

Antibody titers 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.

Time frame: 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

Data from ClinicalTrials.gov

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Birmingham Pediatric Associates Site Number : 8400023

Birmingham, Alabama, United States

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

Jonesboro, Arkansas, United States

California Research Foundation Site Number : 8400003

San Diego, California, United States

Meridian Clinical Research- Sioux City Site Number : 8400007

Sioux City, Iowa, United States

AMR - Newton Site Number : 8400021

Newton, Kansas, United States

Kentucky Pediatrics / Adult Research Site Number : 8400010

Bardstown, Kentucky, United States

Velocity Clinical Research- New Orleans Site Number : 8400012

New Orleans, Louisiana, United States

Velocity Clinical Research Lincoln Site Number : 8400013

Lincoln, Nebraska, United States

Velocity Clinical Research Omaha Site Number : 8400009

Omaha, Nebraska, United States

Meridian Clinical Research Site Number : 8400006

Binghamton, New York, United States

...and 21 more locations

GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs of influenza vaccine 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.

Time frame: 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)

An AE was any untoward medical occurrence in a clinical study 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, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination.

Time frame: 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

Solicited injection site reactions were reactions at and around the injection/administration site of the investigational medicinal product (IMP) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as being related to the IMP administered at that site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and those occurring during the specified collection period were always considered related to the IMP even if there was evidence of alternative etiology.

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

Number of Participants With Unsolicited AEs

Time frame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)

Number of Participants With Medically Attended Adverse Events (MAAEs)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.

Time frame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)

Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)

An SAE was defined as any adverse event 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 other medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.

Time frame: From the first vaccination up to 6 months after the last vaccination, 209 days