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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

Pandemic influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza H5N1, pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Centrum Badań Farmakologii Klinicznej monipol

Outcomes

Primary Outcome Measures

Adverse event rate

Secondary Outcome Measures

Seroconversion and seroprotection after two doses of H5N1 vaccine

Full Information

NCT ID

NCT00434733

First Posted

February 12, 2007

Last Updated

April 23, 2008

Sponsor

Novartis

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00434733

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

Collaborators

Novartis Vaccines

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza H5N1, pandemic

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

4400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Pandemic influenza vaccine

Primary Outcome Measure Information:

Title

Adverse event rate

Secondary Outcome Measure Information:

Title

Seroconversion and seroprotection after two doses of H5N1 vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines and Diagnostics GmbH & Co KG Novartis

Organizational Affiliation

Novartis Vaccines and Diagnostics GmbH & Co KG., Germany

Official's Role

Study Chair

Facility Information:

Facility Name

Centrum Badań Farmakologii Klinicznej monipol

City

Kraków

ZIP/Postal Code

30-969

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

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

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