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Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine

This study is ongoing, but not recruiting participants.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00742885
  Purpose

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.


Condition Intervention Phase
Pandemic Influenza
Biological: (Pre-) pandemic influenza vaccine GSK1557484A
Phase II

MedlinePlus related topics:   Flu   

Drug Information available for:   Influenza Vaccines    Fluvirin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Open Label, Single Group Assignment, Efficacy Study
Official Title:   Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1557484A.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against the H5N1 vaccine strain [ Time Frame: Days 0 and 42 ]
  • Seroconversion Rates (SCR) [ Time Frame: Day 42 ]
  • Seroprotection Rates (SPR) [ Time Frame: Day 42 ]
  • Seroconversion Factors (SCF) [ Time Frame: Days 0, 42 ]

Secondary Outcome Measures:
  • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 7 day follow-up period after each vaccination and overall per subject considering both post-immunisation periods. ]
  • Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84). ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study ]
  • Medically-attended visits [ Time Frame: During the entire study. ]
  • Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against the H5N1 vaccine strain [ Time Frame: Days 0, 21and 182 ]
  • Seroconversion Rates (SCR) [ Time Frame: Days 21 and 182 ]
  • Seroprotection Rates (SPR) [ Time Frame: Days 21 and 182 ]
  • Seroconversion Factors (SCF) [ Time Frame: Days 0, 21 and 182 ]
  • Geometric mean titers (GMTs) of serum anti-H5N1 neutralising antibodies against the H5N1 vaccine strain [ Time Frame: Days 0, 42 and 182 ]
  • Seroconversion Rates (SCR) [ Time Frame: Days 42 and 182 ]
  • The number and percentage of subjects with normal or abnormal haematological and biochemical values [ Time Frame: Days 0, 7 and 42 ]
  • The number and percentage of subjects with normal or abnormal urine values [ Time Frame: Days 0, 7 and 42 ]

Estimated Enrollment:   100
Study Start Date:   September 2008
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
H5N1 Group: Experimental Biological: (Pre-) pandemic influenza vaccine GSK1557484A
Two IM injections

  Eligibility
Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
  • Good general health as assessed by medical history and physical examination.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Written informed consent obtained from the subject.
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria:

  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Diagnosed with cancer, or treatment for cancer within 3 years.
  • Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Receipt of systemic glucocorticoids within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
  • Administration of any registered vaccine within 30 days before study enrolment or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182.
  • Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period.
  • History of previous H5N1 vaccination, or history of H5N1 influenza infection.
  • Receipt of any immunoglobulins and/or any blood products within 6 months of study enrolment or planned administration of any of these products during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine, a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the time of first vaccination.
  • Lactating or nursing.
  • Women of child-bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments; all women will have urine pregnancy tests regardless of their status.
  • Known receipt of analgesic or antipyretic medication on the day of treatment (Day 0).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742885

Locations
Japan
GSK Investigational Site    
      Fukuoka, Japan, 813-0025
GSK Investigational Site    
      Tokyo, Japan, 204-8585

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
  More Information


Responsible Party:   GSK ( Study Director )
Study ID Numbers:   111756
First Received:   August 27, 2008
Last Updated:   October 9, 2008
ClinicalTrials.gov Identifier:   NCT00742885
Health Authority:   Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
Pandemic Influenza  
Immunogenicity  
Safety  

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 October 22, 2008




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