Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00306995

Purpose

Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.

Condition	Intervention	Phase
Influenza	Biological: 3 adjuvanted pandemic influenza candidate vaccines + 4 non-adjuvanted pandemic influenza candidate vaccines	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

humoral immune response

Secondary Outcome Measures:

"safety/reactogenicity in terms of solicited and unsolicited symptoms as well as serious adverse events/antibody persistence 27 weeks and 52 weeks after the 1st vaccination/cell-mediated immune response "

Estimated Enrollment:	385
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol
A male or female aged over 60 years at the time of vaccination.
Written informed consent obtained from the subject.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Participation in an earlier study with a candidate pandemic H9N2 vaccine.
Acute disease at the time of enrolment.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Drug and/or alcohol dependency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306995

Locations

Germany, Brandenburg
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
Germany, Niedersachsen
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
Germany, Sachsen
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Dresden, Sachsen, Germany, 01219
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Germany, Schleswig-Holstein
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	102499
Study First Received:	February 16, 2006
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00306995 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

prophylaxis of pandemic influenza

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009