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NCT00434733 Clinical Trial

Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Influenza Clinical Trial

Official title:
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00434733
Other study ID # V87P4
Secondary ID 2006-005428-18
Status Completed
Phase Phase 3
First received February 12, 2007
Last updated April 23, 2008
Start date January 2007

Study information
Verified date April 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Poland: Central Register of Clinical Trials (CEBK)
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Recruitment information / eligibility
Status Completed
Enrollment 4400
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

- Receipt of another investigational agent within 4 weeks

- Receipt of influenza vaccination for current season 2006/2007.

- any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis

- fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)

- Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control

- Surgery planned during the study period

- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine

- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination

- History of (or current) drug or alcohol abuse

- Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Pandemic influenza vaccine

Locations
Country Name City State
Poland Centrum Badan Farmakologii Klinicznej monipol Kraków

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse event rate
Secondary Seroconversion and seroprotection after two doses of H5N1 vaccine
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