Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

This study is currently recruiting participants.

Verified by Novartis, April 2008

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00481065

Purpose

This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.

Condition	Intervention	Phase
Pandemic Avian Influenza	Biological: H5N1, avian influenza vaccine	Phase II

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-Vaccine and a Seasonal Influenza Vaccine in Adult Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety Objective:safety of the administration of one, two or three doses of an H5N1 influenza vaccine with a seasonal trivalent vaccine.
Primary Immunogenicity Objective:magnitude of antibody responses to one, two or three doses of an H5N1 influenza vaccine and a seasonal trivalent vaccine

Secondary Outcome Measures:

Secondary Immunogenicity ObjectiveKinetics of antibody responses to one booster dose of H5N1-vaccine when given 12 months after the first or second dose

Estimated Enrollment:	400
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 40 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: NCT00481065

Contacts

Contact: Novartis Vaccine Information Services

+1 800 244 7668

Locations

Colombia
	Recruiting
Bogotà, Colombia
Contact: Novartis Drug Information Services +1 800 244 7668

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Drug Information Services +1 800 244 7668

Novartis

More Information

Study ID Numbers:	V87P5
Study First Received:	May 31, 2007
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00481065
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:

Bird flu
influenza vaccine
Seasonal 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:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 13, 2009