Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.

NCT01691339 | Completed Phase 4 Results

• 2 other identifiers: GRC50U 1111-1124-8310
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to \<65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to \<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). Primary Objective:

• To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives:
• To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
• To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
• To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Conditions

Influenza

Keywords

Influenza; Influenza virus vaccine; Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation; Fluzone® High-Dose (Influenza Virus Vaccine) 2012-2013 Formulation; Trivalent Inactivated Influenza Vaccine; Fluzone® Intradermal (Influenza Virus Vaccine) 2012-2013 Formulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

  Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - \>100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.

  Day 0 up to Day 7 post-vaccination

Other Outcomes (4)

• Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

  Day 0 (pre-vaccination) up to Day 21 post-vaccination

• Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

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

• Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

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

Study Arms (4)

Fluzone vaccine (Group 1)

EXPERIMENTAL

Adults 18 to \< 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly

Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation

Fluzone Intradermal vaccine (Group 2)

EXPERIMENTAL

Adults 18 to \< 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally

Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation

Fluzone vaccine (Group 3)

EXPERIMENTAL

Adults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly

Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation

Fluzone High-Dose Vaccine (Group 4)

ACTIVE COMPARATOR

Adults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly

Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation

Interventions

Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone® (2012-2013 Formulation)

Fluzone vaccine (Group 1)

Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation BIOLOGICAL

0.1 mL, Intradermal

Also known as: Fluzone® Intradermal (2012-2013 Formulation)

Fluzone Intradermal vaccine (Group 2)

Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone® High-Dose (2012-2013 Formulation)

Fluzone High-Dose Vaccine (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 2012 - 2013 formulation of influenza vaccine
• Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone, 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
• 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 (HIV), 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

Boca Raton, Florida, 33432, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Council Bluffs, Iowa, 51503, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 4, 2013
• Results First Posted: November 4, 2013

Record last verified: 2013-08

Locations

US (4)