A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Novartis Vaccines3 sites in 1 country125 target enrollmentJune 2007

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: Novartis Vaccines
Enrollment: 125
Locations: 3
Primary Endpoint: Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

July 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

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 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 within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.

Outcomes

Primary Outcomes

Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects