Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00316628
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-04-19
• Study First Submitted QC: 2006-04-19
• Study First Posted: 2006-04-21
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-13
• Last Update Posted: 2006-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 65 years of age or older and in good health

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.
• any acute disease or infections requiring systemic antibiotic or antiviral therapy
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

G. D'Annunzio University; 🇮🇹 Chieti, Italy

Office of Hygiene and Public Health, ASL Lanciano; 🇮🇹 Lanciano, Italy