Overview

This trial is active, not recruiting.

Condition influenza
Treatments fluzone quadrivalent vaccine, 2015-2016 formulation, no preservative, fluzone intradermal quadrivalent vaccine, 2015-2016 formulation, fluzone high dose vaccine, 2015-2016 formulation
Phase phase 4
Sponsor Sanofi Pasteur, a Sanofi Company
Start date September 2015
End date December 2015
Trial size 208 participants
Trial identifier NCT02563093, GRC57, U1111-1161-2491

Summary

The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

Primary Objective:

- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

Observational Objectives:

- To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

- To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable age group with the historical requirements of the CHMP NfG CPMP/BWP/214/96.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Adults 18 to < 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone Quadrivalent vaccine
fluzone quadrivalent vaccine, 2015-2016 formulation, no preservative Fluzone® Quadrivalent, Influenza Vaccine
0.5 mL, Intramuscular (IM)
(Experimental)
Adults 18 to < 65 years of age randomly assigned to receive an intradermal injection of one dose of Fluzone Intradermal Quadrivalent vaccine
fluzone intradermal quadrivalent vaccine, 2015-2016 formulation Fluzone® Intradermal Quadrivalent, Influenza Vaccine
0.1 mL, Intradermal
(Active Comparator)
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone Quadrivalent vaccine
fluzone high dose vaccine, 2015-2016 formulation Fluzone® Quadrivalent Influenza Vaccine
0.5 mL, Intramuscular
(Active Comparator)
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone High Dose vaccine
fluzone high dose vaccine, 2015-2016 formulation Fluzone® High Dose, Influenza Vaccine
0.5 mL, Intramuscular

Primary Outcomes

Measure
Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Fluzone® influenza vaccines
time frame: Day 0 up to Day 21 post-vaccination

Secondary Outcomes

Measure
Geometric mean titers of antibodies to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone® Intradermal Quadrivalent,, or Fluzone® High Dose influenza vaccine
time frame: Day 21 post-vaccination
Seroprotection with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone® Intradermal, or Fluzone® High Dose influenza vaccine
time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Seroconversion with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone® Intradermal, or Fluzone® High Dose influenza vaccine
time frame: Day 21 post-vaccination

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject is ≥ 18 years of age on the day of inclusion - Informed consent form has been signed and dated - Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - History of serious adverse reaction to any influenza vaccine - Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 - Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study - Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator - Prior vaccination with any 2015-2016 formulation of influenza vaccine - Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) - Receipt of immune globulins, blood, or blood-derived products in the past 3 months - Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) - 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 Guillain-Barré syndrome - 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) - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion - Seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C, as reported by the subject. - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures - Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of vaccination. 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 an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.

Additional Information

Official title Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2015-2016 Formulations
Description Adults age 18 to < 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone Intradermal Quadrivalent vaccine and adults age ≥ 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. All subjects will receive a single dose of their randomly assigned vaccine. They will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse reactions 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Sanofi.