Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00449670

Purpose

The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.

Condition	Intervention	Phase
Influenza	Biological: Influenza Vaccine GSK1562902A - 6 different formulations	Phase III

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, Bio-equivalence Study
Official Title:	Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Humoral response in terms of serum anti-haemagglutinin (HA) antibody geometric mean titres (GMT). [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

For the CMI response (in a subset of subjects) • Frequency of influenza-specific CD4/CD8 T-cells in tests producing at least 2 different cytokines [ Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6 + 21 days, and Month 12 ] [ Designated as safety issue: No ]
For the CMI response (in a subset of subjects) • Frequency of influenza-specific CD4/CD8 T-cells in tests producing at least CD40L and another signal molecule. [ Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6 + 21 days, and Month 12 ] [ Designated as safety issue: No ]
For the CMI response (in a subset of subjects) • Frequency of influenza-specific CD4/CD8 T-cells in tests producing at least Interleukin-2 (IL-2) and another signal molecule . [ Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6 + 21 days, and Month 12 ] [ Designated as safety issue: No ]
For the CMI response (in a subset of subjects) • Frequency of influenza-specific CD4/CD8 T-cells in tests producing at least Tumour necrotic factor (TNF-α) and another signal molecule [ Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6 + 21 days, and Month 12 ] [ Designated as safety issue: No ]
For the humoral immune response (in terms of both anti-HA antibodies and neutralising antibodies) • GMT [ Time Frame: At Day 21, Day 42, Month 6, Month 12 in all groups, at Month 6 + 21 days in groups A, B, C & D, at Month 6+42 days in groups E & F. ] [ Designated as safety issue: No ]
For the humoral immune response (in terms of both anti-HA antibodies and neutralising antibodies) • Seroconversion rates (SC) [ Time Frame: At Day 21, Day 42, Month 6, Month 12 in all groups, at Month 6 + 21 days in groups A, B, C & D, at Month 6+42 days in groups E & F. ] [ Designated as safety issue: No ]
For the humoral immune response (in terms of both anti-HA antibodies and neutralising antibodies) • Seroconversion factors (SCF) [ Time Frame: At Day 21, Day 42, Month 6, Month 12 in all groups, at Month 6 + 21 days in groups A, B, C & D, at Month 6+42 days in groups E & F. ] [ Designated as safety issue: No ]
For the humoral immune response (in terms of both anti-HA antibodies and neutralising antibodies)• Seroprotection rates (SP) [ Time Frame: At Day 21, Day 42, Month 6, Month 12 in all groups, at Month 6 + 21 days in groups A, B, C & D, at Month 6+42 days in groups E & F. ] [ Designated as safety issue: No ]

Enrollment:	1181
Study Start Date:	March 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group F: Active Comparator	Biological: Influenza Vaccine GSK1562902A - 6 different formulations 3 doses for experimental groups & 4 doses for control groups, intramuscular injection
Group C: Experimental	Biological: Influenza Vaccine GSK1562902A - 6 different formulations 3 doses for experimental groups & 4 doses for control groups, intramuscular injection
Group D: Experimental	Biological: Influenza Vaccine GSK1562902A - 6 different formulations 3 doses for experimental groups & 4 doses for control groups, intramuscular injection
Group E: Active Comparator	Biological: Influenza Vaccine GSK1562902A - 6 different formulations 3 doses for experimental groups & 4 doses for control groups, intramuscular injection
Group A: Experimental	Biological: Influenza Vaccine GSK1562902A - 6 different formulations 3 doses for experimental groups & 4 doses for control groups, intramuscular injection
Group B: Experimental	Biological: Influenza Vaccine GSK1562902A - 6 different formulations 3 doses for experimental groups & 4 doses for control groups, intramuscular injection

Detailed Description:

The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
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
A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

Administration of any 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 during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups).
Previous vaccination with a pandemic candidate vaccine or a vaccine containing the same adjuvant as the study vaccine.
Previous proven contact with H5N1 wild type virus (i.e. contact with an individual with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry) which died as a result of H5N1 infection).
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 candidate vaccines.
Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of chronic alcohol consumption and/or drug abuse.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the candidate vaccine or during the study.
Lactating women.
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: NCT00449670

Locations

Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
Singapore
GSK Investigational Site
Singapore, Singapore, 308433
GSK Investigational Site
Singapore, Singapore, 529889
Taiwan
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei, Taiwan, 100
Thailand
GSK Investigational Site
Bangkok, Thailand, 10700

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109630, 109873
Study First Received:	March 19, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00449670
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by GlaxoSmithKline:

Influenza
Influenza Vaccine

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009