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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Influenza Immunization

Treatments: Biological: Recombinant influenza vaccine (RIV4); Biological: Quadrivalent influenza vaccine (IIV4)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05513391

2022-000576-19 (EudraCT Number)

U1111-1256-8841 (Registry Identifier)

VAP00026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 366 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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366 participants in 2 patient groups

RIV4 cohort

Experimental group

Description:

RIV4 single injection at Day 1

Treatment:

Biological: Recombinant influenza vaccine (RIV4)

IIV4 cohort

Active Comparator group

Description:

IIV4, single injection at Day 1

Treatment:

Biological: Quadrivalent influenza vaccine (IIV4)