Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
This trial is active, not recruiting.
|Treatments||fluzone quadrivalent vaccine, 2016 2017 formulation, no preservative, fluzone high dose, vaccine, 2016 2017 formulation|
|Sponsor||Sanofi Pasteur, a Sanofi Company|
|Start date||September 2016|
|End date||December 2016|
|Trial size||180 participants|
|Trial identifier||NCT02908269, GRC71, U1111-1174-4738|
The aim of the study is to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Primary Observational Objectives
- To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
- To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
- To submit available sera from approximately 90 subjects (30 subjects 3 to < 9 years of age and 30 subjects 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 subjects ≥ 65 years of age who receive Fluzone High-Dose vaccine) to CBER for further analysis by the WHO, the CDC, and the FDA to support formulation recommendations for subsequent influenza vaccines.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Either Fluzone® Quadrivalent and High Dose vaccines
time frame: Day 0 up to Day 21 or Day 28 post vaccination
Geometric mean titers of antibodies to vaccine antigens following vaccination with either Fluzone® Quadrivalent or Fluzone® High Dose Influenza Vaccine
time frame: Day 0 and Day 21 or Day 28 post final vaccination
Seroprotection with respect to vaccine antigens following vaccination with either Fluzone® Quadrivalent or Fluzone® High Dose Influenza Vaccine
time frame: Day 0 and Day 21 or 28 post final vaccination
Seroconversion with respect to vaccine antigens following vaccination with either Fluzone® Quadrivalent or Fluzone® High Dose Influenza Vaccine
time frame: Day 21 or 28 post vaccination
Male or female participants at least 3 years old.
Inclusion Criteria: - Aged 3 to < 9 years or adult aged ≥ 18 years on the day of first study vaccination (study product administration) . - Informed consent form has been signed and dated by subjects ≥ 18 years of age. - Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for subjects 3 to < 9 years of age. - Subject and parent/guardian (of subjects 3 to < 9 years of age) are able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - Subject 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 and until at least 4 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 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. - Receipt of any vaccine in the 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for subjects receiving 1 dose of influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine. - Previous vaccination against influenza (in the 2016-2017 influenza season) with either the trial vaccine or another 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). - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances. - Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. - Current alcohol abuse or drug addiction. - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥ 100.4°F [38.0°C]). A prospective subject 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 (subjects ≥18 years of age) or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (all subjects). - History of serious adverse reaction to any influenza vaccine. - Personal history of Guillain-Barré syndrome. - Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. - Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder. - Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
|Official title||Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations|
|Description||All participants will receive a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For subjects 3 to < 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) will be administered during Visit 2. Participants will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse event information will be collected for 7 days after vaccination. Unsolicited non-serious adverse events (AEs) and serious adverse events (SAEs) will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses of study vaccine. Immunogenicity will be evaluated in all subjects prior to vaccination on day 0 (Visit 1) and on day 28 for 3 to < 9 year olds and 21 days for adults 18 years and older, following final vaccination.|
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