Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

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”

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.

Intervention(s) in this Clinical Trial

• Biological: 3 adjuvanted pandemic influenza candidate vaccines + 4 non-adjuvanted pandemic influenza candidate vaccines

Primary Measures

• humoral immune response

Secondary 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 "

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00306995

Study ID Number: 102499

ClinicalTrials.gov Identifier: NCT00306995

Health Authority: Germany: Paul-Ehrlich-Institut