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

Influenza Clinical Trial

Official title:

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522236
• Other study ID #: V70P5S
• Secondary ID: 2007-000966-19
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2007
• Last updated: January 24, 2012
• Start date: June 2007
• Est. completion date: July 2007

Study information

• Verified date: January 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministero Della Salute, EMEA
• Study type: Interventional

Clinical Trial Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years of age or older

Exclusion Criteria:

• any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent 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 kanamycin 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

• any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days

• fever within the past 3 days

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45µg of viral hemagglutinin, composed of 15µg of the three influenza antigens: A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain) A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain) B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season. The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes. A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.

Locations

Country	Name	City	State
Italy	Dipartimento di Medicina e Scienze dell'Invecchiamento	Chieti
Italy	Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37	Lanciano

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (=65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)	The measures of immunogenicity for each antigen are: the geometric mean area (GMA) on Day 0 and Day 21; the Day 21/Day 0 geometric mean area ratio (GMR); the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2; the percentage of subjects achieving an SRH area = 25 mm2 on Day 0 and Day 21; Seroconversion is defined as negative prevaccination serum/postvaccination serum area = 25 mm2.; Significant increase in antibody titer is defined as at least a 50% increase in area.	21 days post-vaccination	No
Secondary	To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (= 65 years).	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).	3 days, respectively 21 days post-vaccination	Yes