Clinical trial NCT00506350: Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
Official title: Evaluate the Reactogenicity & Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults Aged Between 19 & 61 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 350
Sex: ALL
Minimum age (years): 19
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)

Detailed description: The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. The persistence of antibodies will be analysed at 6, 12, 18 and 24 months.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* For previously primed subjects: participation in the primary study (NCT00309634).
* For unprimed subjects: male or female between and including, 19 and 61 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 she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a licenced vaccine not foreseen by the study protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of the first dose of vaccine(s).
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Applicable for control group only: previous vaccination with a pandemic candidate vaccine or a vaccine containing the investigational vaccine adjuvant.
* History of hypersensitivity to vaccines.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures.
* Acute disease at the time of enrolment.
* Acute or chronic, 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.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
* Lactating female.
* History of chronic alcohol consumption and/or drug abuse

Primary outcomes:
measure: Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Day 0
measure: Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Day 21
measure: Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Day 21
measure: Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Day 21
measure: Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Day 0
measure: Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Day 21
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) follow-up period after the first vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (From Day 0 up to Month 24)
Secondary outcomes:
measure: Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain
timeFrame: At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)
measure: Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain
timeFrame: At Months 6, 12, 18 and 24
measure: Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Days 0, 7, 14, 21, 28, 35 and 42
measure: Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Months 6, 12, 18 and 24
measure: Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Days 7,14, 21, 35 and 42
measure: Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Months 6, 12, 18 and 24
measure: Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Days 21 (post-vaccination one) and 42 (post-vaccination two)
measure: Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Months 6, 12, 18 and 24
measure: Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Days 7, 14, 21, 35 and 42
measure: Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Months 6, 12, 18 and 24
measure: Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Days 0, 7, 14, 21, 28, 35 and 42
measure: Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
timeFrame: At Months 6, 12, 18 and 24
measure: Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
timeFrame: At Days 0 and 21
measure: Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
timeFrame: At Months 6, 12, 18 and 24
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: