Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.

Influenza Disease Clinical Trial

Official title:

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, When Administered to Non-Elderly Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316615
• Other study ID #: V71P3S
• Secondary ID: Eudract number:
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2006
• Last updated: September 13, 2006
• Start date: June 2005

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

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• subjects 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

• 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

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 Disease
• Influenza, Human

Intervention

Biological:
• influenza vaccine

Locations

Country	Name	City	State
Italy	G. D'Annunzio University	Chieti
Italy	Office of Hygiene and Public Health, ASL Lanciano	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).