Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (NCT00742885) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine
Japan100 participantsStarted 2008-09-01
Plain-language summary
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.
Who can participate
Age range20 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 imm…
What they're measuring
1
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Timeframe: At Day 0 and Day 42
2
Number of Subjects Seroconverted for H5N1 HI Antibodies
Timeframe: At Day 42
3
HI Antibody Seroconversion Factors for H5N1 HI Antibodies
Timeframe: At Day 0 and Day 42
4
Number of Subjects Seroprotected for H5N1 HI Antibodies
Timeframe: At Day 42
5
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain