Back to resultsEvaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
GSK1562902A non-AD F1 Primed Group
GSK1562902A non-AD F2 Primed Group
GSK1562902A non-AD F3 Primed Group
GSK1562902A non-AD F4 Primed Group
GSK1562902A AD F1 Primed Group
GSK1562902A AD F2 Primed Group
GSK1562902A AD F3 Primed Group
GSK1562902A AD Approved F4 Primed Group
Control Group
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Outcomes
Primary Outcome Measures
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Secondary Outcome Measures
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.
Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.
The flu strain assessed was A/Indonesia/05/2005 (H5N1).
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506350
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2007 (Actual)
Primary Completion Date
October 12, 2009 (Actual)
Study Completion Date
October 12, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1562902A non-AD F1 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A non-AD F2 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A non-AD F3 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A non-AD F4 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A AD F1 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A AD F2 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A AD F3 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
GSK1562902A AD Approved F4 Primed Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
Intervention Description
A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Intervention Type
Biological
Intervention Name(s)
Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Intervention Description
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Primary Outcome Measure Information:
Title
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Day 0
Title
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Day 21
Title
Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame
At Day 21
Title
Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Day 21
Title
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Day 0
Title
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Day 21
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
Time Frame
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
Time Frame
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame
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
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame
During the 30-day (Days 0-29) follow-up period after the first vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the entire study period (From Day 0 up to Month 24)
Secondary Outcome Measure Information:
Title
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain
Description
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.
Time Frame
At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)
Title
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain
Description
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Months 6, 12, 18 and 24
Title
Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Days 0, 7, 14, 21, 28, 35 and 42
Title
Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Months 6, 12, 18 and 24
Title
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Time Frame
At Days 7,14, 21, 35 and 42
Title
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Time Frame
At Months 6, 12, 18 and 24
Title
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
Time Frame
At Days 21 (post-vaccination one) and 42 (post-vaccination two)
Title
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
Time Frame
At Months 6, 12, 18 and 24
Title
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
Time Frame
At Days 7, 14, 21, 35 and 42
Title
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.
Time Frame
At Months 6, 12, 18 and 24
Title
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.
The flu strain assessed was A/Indonesia/05/2005 (H5N1).
Time Frame
At Days 0, 7, 14, 21, 28, 35 and 42
Title
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).
Time Frame
At Months 6, 12, 18 and 24
Title
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Description
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.
Time Frame
At Days 0 and 21
Title
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Description
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.
Time Frame
At Months 6, 12, 18 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109817
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
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