A Phase II, Single Center, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine [Ph.Eur], Formulation 2009/2010, When Administered to Non-Elderly Adult and Elderly Subjects

Novartis1 site in 1 country126 target enrollmentJune 2009

ConditionsInfluenza Seasonal Influenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: Novartis
Enrollment: 126
Locations: 1
Primary Endpoint: Immunogenicity and tolerability of the Flu vaccines is being measured
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

July 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Immunogenicity and tolerability of the Flu vaccines is being measured

Time Frame: 2 - 21 days

Secondary Outcomes

To evaluate safety of a single IM (intramuscular) dose of the subunit vaccine of Influenza Vaccine Surface Antigen, Inactivated of Influenza Vaccine(21 days)