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

NCT02563093 | Completed Phase 4 Results

• 2 other identifiers: GRC57U1111-1161-2491
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 4

Brief 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 Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal Products (CPMP) - CHMP NfG CPMP/BWP/214/96.

Conditions

Influenza

Keywords

Influenza; Fluzone® Quadrivalent, Influenza Vaccine; Fluzone® Intradermal Quadrivalent, Influenza Vaccine; Fluzone® High Dose, Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine

  Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set.

  Day 0 up to Day 7 post-vaccination

Secondary Outcomes (4)

• Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine

  Day 0 (pre-vaccination) and 21 days post-vaccination

• Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine

  Day 0 (Pre-vaccination) and 21 days post-vaccination

• Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine

  21 days post-vaccination

• Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine

  21 days post-vaccination

Study Arms (4)

Study Group 1

EXPERIMENTAL

Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone Quadrivalent vaccine

Biological: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative

Study Group 2

EXPERIMENTAL

Adults 18 to \< 65 years of age randomly assigned to receive an intradermal injection of one dose of Fluzone Intradermal Quadrivalent vaccine

Biological: Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation

Study Group 3

EXPERIMENTAL

Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone Quadrivalent vaccine

Biological: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative

Study Group 4

EXPERIMENTAL

Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone High-Dose vaccine

Biological: Fluzone High-Dose vaccine, 2015-2016 formulation

Interventions

Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative BIOLOGICAL

0.5 mL, Intramuscular (IM)

Also known as: Fluzone® Quadrivalent, Influenza Vaccine

Study Group 1

Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation BIOLOGICAL

0.1 mL, Intradermal

Also known as: Fluzone® Intradermal Quadrivalent, Influenza Vaccine

Study Group 2

Fluzone High-Dose vaccine, 2015-2016 formulation BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone® High-Dose, Influenza Vaccine

Study Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

Unknown Facility

Santa Rosa, California, 95405, United States

Location

Unknown Facility

Council Bluffs, Iowa, 51503, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Cincinnati, Ohio, 45249, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2016

Record last verified: 2016-10

Locations

US (4)