A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects

Novartis3 sites in 1 country126 target enrollmentJune 2009

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Seasonal Influenza
Sponsor: Novartis
Enrollment: 126
Locations: 3
Primary Endpoint: Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Status: Completed
Last Updated: 9 years ago

This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

June 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•Subjects eligible for enrollment into this study are male and female adults who are
•≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
•Able to comply with all study requirements
•In good health as determined by:
•Medical history;
•Physical examination;
•Clinical judgment of the investigator. Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

•Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
•They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
•Cancer, except for localized skin cancer;
•Advanced congestive heart failure;
•Chronic obstructive pulmonary disease (COPD);
•Autoimmune disease (including rheumatoid arthritis);
•Acute or progressive hepatic disease;
•Acute or progressive renal disease;
•Severe neurological or psychiatric disorder;
•Severe Asthma.