Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults

Influenza Clinical Trial

Official title:

Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2015-2016 Formulations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02563093
• Other study ID #: GRC57
• Secondary ID: U1111-1161-2491
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 28, 2015
• Last updated: January 4, 2016
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
0.5 mL, Intramuscular (IM)
• Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
0.1 mL, Intradermal
• Fluzone High Dose vaccine, 2015-2016 formulation
0.5 mL, Intramuscular
• Fluzone High Dose vaccine, 2015-2016 formulation
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Fluzone® influenza vaccines	Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected.	Day 0 up to Day 21 post-vaccination	No
Secondary	Geometric mean titers of antibodies to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone® Intradermal Quadrivalent,, or Fluzone® High Dose influenza vaccine	Immunogenicity will be evaluated prior to vaccination and at 21 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers (GMTs) will be determined.	Day 21 post-vaccination	No
Secondary	Seroprotection with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone® Intradermal, or Fluzone® High Dose influenza vaccine	Seroprotection is defined as a titer = 40 (l/dil) at pre-vaccination and at 21 days after vaccination.	Day 0 (pre-vaccination) and Day 21 post-vaccination	No
Secondary	Seroconversion with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone® Intradermal, or Fluzone® High Dose influenza vaccine	Seroconversion is defined as either a pre vaccination titer < 10 (1/dil) and a post-vaccination titer = 40 (1/dil), or a pre vaccination titer = 10 (1/dil) and a = 4-fold increase in post-vaccination titer at 21 days after vaccination.	Day 21 post-vaccination	No

External Links

•   Link
•   Link