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

Sanofi Pasteur, a Sanofi Company1,308 enrolled

Overview

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.

The participation duration was approximately 6 months for each participant.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,308

Conditions

Influenza Immunization

Interventions

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

Pharmaceutical form: Solution for injection Route of administration: intramuscular

Eligibility

Sex: ALLMin age: 9 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 9 to 49 years on the day of inclusion * 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 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 was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (35)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 29

Secondary Outcomes

GMTs Against Influenza Vaccine Antibodies at Day 1

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Time frame: Pre-vaccination on Day 1

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

Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 and \>=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Time frame: On Days 1 and 29

Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies

GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Data from ClinicalTrials.gov

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Alabama Clinical Therapeutics North Tower Site Number : 8400024

Birmingham, Alabama, United States

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 Pediatics / Adult Research Site Number : 8400010

Bardstown, Kentucky, United States

Velocity Clinical Research Site Number : 8400012

New Orleans, Louisiana, United States

Velocity Clinical Research Lincoln Site Number : 8400013

Lincoln, Nebraska, United States

Meridian Clinical Research Norfolk Site Number : 8400011

Norfolk, Nebraska, United States

...and 25 more locations

Time frame: On Days 1 and 29

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical investigation 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, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs.

Time frame: Within 30 minutes post-vaccination on Day 1

Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.

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

Number of Participants With Unsolicited AEs

Time frame: From Day 1 up to 28 days post-vaccination (up to Day 29)

Number of Participants With Medically Attended Adverse Events (MAAEs)

An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.

Time frame: From Day 1 up to 28 days post-vaccination (up to Day 29)

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

An SAE was any untoward medical occurrence 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 an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

Time frame: From Day 1 up to 6 months post-vaccination, 181 days