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Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Surface Antigen, Inactivated, Influenza (form.2006-07)
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, adult, elderly, vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: 18 years of age or older Exclusion Criteria: any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated 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 polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) fever within the past 3 days history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine within the past 12 months have received more than one injection of influenza vaccine Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)

Sites / Locations

  • Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini
  • Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37

Outcomes

Primary Outcome Measures

CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Outcome Measures

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
May 23, 2006
Last Updated
September 13, 2006
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00329966
Brief Title
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
Official Title
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, adult, elderly, 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
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Surface Antigen, Inactivated, Influenza (form.2006-07)
Primary Outcome Measure Information:
Title
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary Outcome Measure Information:
Title
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Title
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Title
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Exclusion Criteria: any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated 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 polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) fever within the past 3 days history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine within the past 12 months have received more than one injection of influenza vaccine Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Chair
Facility Information:
Facility Name
Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37
City
Lanciano
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

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