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

Influenza Clinical Trial

Official title:

Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines, 2014-2015 Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258334
• Other study ID #: GRC55
• Secondary ID: U1111-1143-8931
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2014
• Last updated: September 16, 2015
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• 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 this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.

Objectives:

• To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.

Observational objectives:

• To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2014-2015 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, and Fluzone® High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Description:

Adults 18 to < 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• 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 2014-2015 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, 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 pre-menarche or 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, 2014-2015 formulation
0.5 mL, Intramuscular
• Fluzone I®ntradermal vaccine, 2014-2015 formulation
0.1 mL, Intradermal
• Fluzone® Quadrivalent vaccine, 2014-2015 formulation
0.5 mL, Intramuscular
• Fluzone High Dose vaccine, 2014-2015 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	Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, =39.0°C or =102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.	Day 0 up to Day 7 post-vaccination	No
Secondary	Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.	Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.	Day 0 (pre-vaccination) and Day 21 post-vaccination	No
Secondary	Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.	Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer =40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.	Day 0 (pre-vaccination) and Day 21 post-vaccination	No
Secondary	Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was 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 21 days after vaccination.	Day 21 post-vaccination	No
Secondary	Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine	Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.	Day 21 post-vaccination	No

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