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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 23, 2006

Last Updated Date

September 13, 2006

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00329966 on ClinicalTrials.gov Archive Site

Current 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).

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Influenza

Intervention ^†

Biological: Surface Antigen, Inactivated, Influenza (form.2006-07)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

100

Completion Date

Primary Completion Date

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00329966

Responsible Party

Secondary IDs ^††

Eudract no.2006-000609-43

Study Sponsor ^†

Novartis

Collaborators ^††

Novartis Vaccines

Investigators ^†

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

Information Provided By

Novartis

Verification Date

September 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.