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

Novartis2 sites in 1 country100 target enrollmentJune 2006

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: Novartis
Enrollment: 100
Locations: 2
Primary Endpoint: CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Status: Completed
Last Updated: 19 years ago

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

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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)

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

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).