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Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Adjuvanted Influenza Vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 65 years of age or older

Exclusion Criteria:

  • any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
  • hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
  • history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
  • known or suspected (or high risk of developing) impairment/alteration of immune function
  • any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
  • fever within the past 3 days

Sites / Locations

  • Dipartimento di Medicina e Scienze dell'Invecchiamento
  • Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
The measures of immunogenicity for each antigen are: the geometric mean area (GMA) on Day 0 and Day 21 the Day 21/Day 0 geometric mean area ratio (GMR) the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21 Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. Significant increase in antibody titer is defined as at least a 50% increase in area.

Secondary Outcome Measures

To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Full Information

First Posted
August 28, 2007
Last Updated
January 24, 2012
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00522236
Brief Title
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects
Official Title
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Adjuvanted Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
Intervention Description
A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens: A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain) A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain) B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season. The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes. A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.
Primary Outcome Measure Information:
Title
Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
Description
The measures of immunogenicity for each antigen are: the geometric mean area (GMA) on Day 0 and Day 21 the Day 21/Day 0 geometric mean area ratio (GMR) the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21 Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. Significant increase in antibody titer is defined as at least a 50% increase in area.
Time Frame
21 days post-vaccination
Secondary Outcome Measure Information:
Title
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
Description
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Time Frame
3 days, respectively 21 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 65 years of age or older Exclusion Criteria: any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days fever within the past 3 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Dipartimento di Medicina e Scienze dell'Invecchiamento
City
Chieti
Country
Italy
Facility Name
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37
City
Lanciano
ZIP/Postal Code
66034
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

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