Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-Adjuvanted Influenza Vaccines

This study is ongoing, but not recruiting participants.

First Received: May 24, 2007 Last Updated: April 23, 2008 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00478816

Purpose

Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects

Condition	Intervention	Phase
Prophylaxis of Avian Influenza Vaccine	Biological: Avian influenza vaccine	Phase I

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Single Center, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With MF59-Adjuvanted or Non-Adjuvanted H5N3 Influenza Vaccines

Further study details as provided by Novartis:

Primary Outcome Measures:

Cell-mediated immunity, magnitude, breath and kinetics of antibody response to 2 doses of MF59-adjuvanted H5N1 influenza vaccine, in subjects primed by previous vaccination with either MF59-adjuvanted or non-adjuvanted H5N3 influenza vaccine.

Secondary Outcome Measures:

Safety Objectives: safety and reactogenicity of the vaccine

Estimated Enrollment:	60
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: - Healthy subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478816

Locations

United Kingdom
Infectious Diseases Unit
Leicester, United Kingdom

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines Information Service +41 61 324 1111

Novartis

More Information

No publications provided

Study ID Numbers:	V87P3
Study First Received:	May 24, 2007
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00478816 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Bird flu
influenza vaccine
prepandemic vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009