Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00518726
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-21
• Status Verified: 2011-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (3)

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

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale; 🇮🇹 Via S. Spaventa, 37, Lanciano, Chieti, Italy

Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena; 🇮🇹 Siena, Italy