Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age
Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age
The primary objectives of the study are:

 -  To describe the safety profile of the different quadrivalent recombinant influenza
 vaccine (RIV) formulations.

 -  To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody
 responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens
 present in the control vaccine in all groups at all timepoints.

 The secondary objectives of the study are:

 -  To describe antigenic coverage in each group by assessing the HAI and SN antibody
 responses against a panel of H3 antigens (not present in any of the vaccine
 formulations).

 -  To describe HAI and SN antibody responses in each group against each of the H3 antigens.

 -  To compare the HAI and SN antibody responses for the groups with different H3 antigens
 to the control group.
Study duration per participant is approximately 90 days.
Inclusion criteria :

 -  Aged 18 to 30 years on the day of inclusion

 -  Informed consent form has been signed and dated

 -  Able to attend all scheduled visits and to comply with all study procedures

 Exclusion criteria:

 -  Participant is pregnant, or lactating, or of childbearing potential and not using an
 effective method of contraception or abstinence from at least 4 weeks prior to
 vaccination until at least 12 weeks after vaccination. To be considered of
 non-childbearing potential, a female must be pre-menarche, or post-menopausal for at
 least 1 year, or surgically sterile

 -  Participation at the time of study enrollment (or in the 4 weeks preceding the study
 vaccination) or planned participation during the present study period in another
 clinical study investigating a vaccine, drug, medical device, or medical procedure

 -  Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned
 receipt of any vaccine in the 4 weeks following study vaccination

 -  Previous vaccination against influenza in the previous influenza season (2018-2019)
 with any licensed or investigational influenza vaccine

 -  Previous vaccination against influenza in the 2019-2020 season with any licensed
 influenza vaccine

 -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

 -  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)

 -  Have known active or recently active (12 months) neoplastic disease or a history of
 any hematologic malignancy

 -  History of influenza infection during the 2018-2019 or 2019-2020 influenza season,
 confirmed by laboratory tests (including rapid tests)

 -  Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis
 B, or hepatitis C

 -  Known systemic hypersensitivity to any of the vaccine components, or history of a
 life-threatening reaction to the vaccines used in the study or to a vaccine containing
 any of the same substances

 -  Thrombocytopenia or bleeding disorder, contraindicating intramuscular vaccination
 based on Investigator's judgement

 -  Deprived of freedom by an administrative or court order, or in an emergency setting,
 or hospitalized involuntarily

 -  Alcohol abuse or substance abuse that, in the opinion of the investigator, might
 interfere with the study conduct or completion

 -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
 interfere with study conduct or completion or predispose to complications associated
 with influenza infection

 -  Have any diagnosis, current or past, of chronic pulmonary diseases including asthma,
 cystic fibrosis and chronic pulmonary obstructive disease

 -  Have taken high-dose inhaled corticosteroids within 6 months prior to study
 vaccination

 -  Body Mass Index of 40 or higher

 -  History of cardiac disease such as congenital heart disease, heart failure, coronary
 artery disease (except isolated hypertension)

 -  Health care personnel in inpatient and outpatient care settings, medical
 emergency-response workers, employees of nursing home and long-term care facilities
 who have contact with patients or residents and students in these professions who will
 have contact with patients

 -  Moderate or severe acute illness/infection (according to investigator judgment) on the
 day of vaccination or febrile illness (temperature ≥ 100.4 F [≥ 38.0 C]). A
 prospective participant should not be included in the study until the condition has
 resolved or the febrile event has subsided

 -  Identified as an Investigator or employee of the Investigator or study center with
 direct involvement in the proposed study, or identified as an immediate family member
 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with
 direct involvement in the proposed study

 -  Personal or family history of Guillain-Barré syndrome

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.