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NCT00342940 Clinical Trial

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, Single 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Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00342940
Other study ID # V78P4S
Secondary ID Eudract number:2
Status Withdrawn
Phase Phase 2
First received June 20, 2006
Last updated April 19, 2017
Start date October 2006

Study information
Verified date April 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male and female subjects 18 years of age or older

Exclusion Criteria:

- any auto-immune disease or other serious acute, chronic or progressive disease

- 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

- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• influenza surface antigen inactivated vaccine

Locations
Country Name City State
United Kingdom Chiltern International Limited , Chiltern Place, Upton Road Slough

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

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).
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