Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00397215

Purpose

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Condition	Intervention	Phase
Pandemic Flu	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) Biological: Fluarix	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluate Immunogenicity & Safety of a Single or Double-Dose of the Pandemic Influenza Candidate Vaccine (GSK1562902A) Given Following a Two-Administration Schedule (21 Days Apart) in Adults Over 60 Yrs

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Humoral immune response in terms of anti-HA antibodies: Geometric mean titres [ Time Frame: Days 0, 21, 42, 180, Month 12 and Month 24 ]
Humoral immune response in terms of anti-HA antibodies: Seroconversion rates [ Time Frame: Days 21, 42, 180, Month 12 and Month 24 ]
Humoral immune response in terms of anti-HA antibodies: Seroconversion factors [ Time Frame: Days 21, 42, 180, Month 12 and Month 24 ]
Humoral immune response in terms of anti-HA antibodies: Seroprotection rates [ Time Frame: Days 0, 21, 42, 180, Month 12 and Month 24 ]
Humoral immune response in terms of neutralizing antibodies: Geometric mean titres [ Time Frame: Days 0, 42, 180, Month 12 and Month 24 ]
Humoral immune response in terms of neutralizing antibodies: Seroconversion rates [ Time Frame: Days 42, 180, Month 12 and Month 24 ]

Secondary Outcome Measures:

Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: 7 days ]
Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: 21 days following the first vaccination and 30 days following the second vaccination ]
Occurrence of SAEs [ Time Frame: The entire study period ]
Biochemical assessments and hematological analysis. [ Time Frame: Day 0, Day 2, Day 21, Day 23 ]
Cell-mediated immunity response evaluation: Frequency of influenza-specific CD4/CD8 T-cells tests producing at least two different cytokines [ Time Frame: Days 0, 21, 42, 180, Month 12 and Month 24 ]

Enrollment:	437
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
A: Experimental Single dose + adjuvant	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) intramuscular injection Biological: Fluarix Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
B Single dose	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) intramuscular injection Biological: Fluarix Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
C: Experimental Double dose + adjuvant	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) intramuscular injection Biological: Fluarix Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
D Double dose	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) intramuscular injection Biological: Fluarix Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

Detailed Description:

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of H5N1 influenza antibodies will also be evaluated up to two years after vaccination (neutralizing antibodies will only be evaluated in a subset of subjects in the adjuvanted groups). Single and double dose of H5N1 vaccine non-adjuvanted vaccine will be used as comparator.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged 61 years or above at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well controlled underlying disease.

Exclusion Criteria:

Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of chronic alcohol consumption and/or drug abuse.
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Acute disease at the time of enrolment.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination
Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397215

Locations

Belgium
GSK Clinical Trials Call Center
Brussels, Belgium
Italy
GSK Clinical Trials Call Center
Genova, Italy

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	108251, 108252, 111275, 111276
Study First Received:	November 7, 2006
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00397215
Health Authority:	Italy: Ethics Committee

Keywords provided by GlaxoSmithKline:

influenza
H5N1
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 14, 2009