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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Influenza Immunization

Treatments: Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH

Study type: Interventional

Funder types: Industry

Identifiers

NCT05513053

2022-000577-11 (EudraCT Number)

VAP00027

U1111-1260-4678 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

The participation duration was approximately 6 months for each participant.

Enrollment: 1,308 patients

Sex: All

Ages: 9 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,308 participants in 2 patient groups

Group 9 to 17 years old

Experimental group

Description:

Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01

Treatment:

Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH

Group 18 to 49 years old

Experimental group

Description:

Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01

Treatment:

Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH