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

Influenza Clinical Trial

Official title:

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329966
• Other study ID #: V71P4S
• Secondary ID: Eudract no.2006-
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2006
• Last updated: September 13, 2006
• Start date: June 2006

Study information

• Verified date: September 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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)

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, Influenza (form.2006-07)

Locations

Country	Name	City	State
Italy	Dipartimento di Medicina e Scienze dell’Invecchiamento Università G. D’AnnunzioVia dei Vestini	Chieti
Italy	Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37	Lanciano

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary	Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Secondary	Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Secondary	Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).