Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00329966
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-05-23
• Study First Submitted QC: 2006-05-23
• Study First Posted: 2006-05-25
• Study Start: 2006-06
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-13
• Last Update Posted: 2006-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years of age or older

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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 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)

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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)

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37; 🇮🇹 Lanciano, Italy

Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini; 🇮🇹 Chieti, Italy