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

Phase 1

Conditions: MedDRA version: 21.1Level: PTClassification code 10059429Term: Influenza immunisationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2022-000577-11-CZ

Lead Sponsor: Sanofi Pasteur Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1308

Inclusion Criteria

- Aged 9 to 49 years on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1) Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarchec, postmenopausal for at least 1 year, or surgically sterile OR 2) Is of childbearing potential and agrees 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 has been signed and dated by the participant (based on local regulations), and if applicable informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
Are the trial subjects under 18? yes
Number of subjects for this age range: 667
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 667
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- 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-Barré 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.