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Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.
This study is a year 3 revaccination study. Second year revaccination was done in study 107973 (NCT00386113). First year revaccination was done in study 104540 (NCT00318058). Primary study was study 103304.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Experimental | Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). |
|
| Fluarix Group | Active Comparator | Subjects received 1 dose of Fluarix™. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' influenza vaccine GSK576389A | Biological | Single dose, intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. | During a 7-day follow-up period after vaccination |
| Duration of Solicited Local Symptoms | Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade. | During a 7-day follow-up period after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination. | During a 7-day follow-up period after vaccination |
| Duration of Solicited General Symptoms | Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. | During a 7-day follow-up period after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | At Days 0 and 21 |
| Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110223 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | FluAS25 (GSK576389A) Group | Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). |
| FG001 | Fluarix Group | Subjects received 1 dose of Fluarix™. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FluAS25 (GSK576389A) Group | Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). |
| BG001 | Fluarix Group | Subjects received 1 dose of Fluarix™. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. | The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered. | Posted | Number | Subjects | During a 7-day follow-up period after vaccination |
|
Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FluAS25 (GSK576389A) Group | Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C510903 | fluarix |
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| Fluarix™ | Biological | Single dose, intramuscular injection |
|
Unsolicited AE covers any AE 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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.
| During a 21-day follow-up period after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination. | During a 21-day follow-up period after vaccination |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination. | Throughout the entire study (up to Day 21) |
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| At Days 0 and 21 |
| Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | At Day 21 |
| Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | At Day 21 |
| Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | At Days 0 and 21 |
| Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other. | At Days 0 and 21 |
| Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other. | At Days 0 and 21 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110223 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110223 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110223 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110223 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110223 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received 1 dose of Fluarix™. |
|
|
| Primary | Duration of Solicited Local Symptoms | Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade. | The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom. | Posted | Median | Full Range | Days | During a 7-day follow-up period after vaccination |
|
|
|
| Primary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered. | Posted | Number | Subjects | During a 7-day follow-up period after vaccination |
|
|
|
| Primary | Duration of Solicited General Symptoms | Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. | The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom. | Posted | Median | Full Range | Days | During a 7-day follow-up period after vaccination |
|
|
|
| Primary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE 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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered. | Posted | Number | Subjects | During a 21-day follow-up period after vaccination |
|
|
|
| Primary | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered. | Posted | Number | Subjects | During a 21-day follow-up period after vaccination |
|
|
|
| Primary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered. | Posted | Number | Subjects | Throughout the entire study (up to Day 21) |
|
|
|
| Secondary | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0 and 21 |
|
|
|
| Secondary | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Days 0 and 21 |
|
|
|
| Secondary | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Mean | 95% Confidence Interval | fold increase | At Day 21 |
|
|
|
| Secondary | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Days 0 and 21 |
|
|
|
| Secondary | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | Standard Deviation | Cells per million | At Days 0 and 21 |
|
|
|
| Secondary | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | Standard Deviation | Cells per million | At Days 0 and 21 |
|
|
|
| 0 |
| 33 |
| 24 |
| 33 |
| EG001 | Fluarix Group | Subjects received 1 dose of Fluarix™. | 0 | 35 | 17 | 35 |
| Swelling | General disorders | Non-systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Arthralgia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Myalgia | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Redness (N= 10; 4) |
|
| Swelling (N= 2; 2) |
|
| Related arthralgia |
|
| Any fatigue |
|
| Grade 3 fatigue |
|
| Related fatigue |
|
| Any headache |
|
| Grade 3 headache |
|
| Related headache |
|
| Any myalgia |
|
| Grade 3 myalgia |
|
| Related myalgia |
|
| Any nausea |
|
| Grade 3 nausea |
|
| Related nausea |
|
| Any shivering |
|
| Grade 3 shivering |
|
| Related shivering |
|
| Any fever |
|
| Grade 3 fever |
|
| Related fever |
|
| Headache (N= 8; 3) |
|
| Myalgia (N= 8; 1) |
|
| Nausea (N= 3; 1) |
|
| Shivering (N= 6; 3) |
|
| Fever (N= 1; 0) |
|
| Related AEs |
|
| Related MSCs |
|
| A/Wisconsin [Day 0] |
|
| A/Wisconsin [Day 21] |
|
| B/Malaysia [Day 0] |
|
| B/Malaysia [Day 21] |
|
| A/Wisconsin [Day 0] |
|
| A/Wisconsin [Day 21] |
|
| B/Malaysia [Day 0] |
|
| B/Malaysia [Day 21] |
|
| B/Malaysia |
|
| B/Malaysia |
|
| A/Wisconsin [Day 0] |
|
| A/Wisconsin [Day 21] |
|
| B/Malaysia [Day 0] |
|
| B/Malaysia [Day 21] |
|
| All Doubles A/Wisconsin [Day 0] (N= 30; 32) |
|
| All Doubles A/Wisconsin [Day 21] (N= 25; 31) |
|
| All Doubles B/Malaysia [Day 0] (N= 30; 32) |
|
| All Doubles B/Malaysia [Day 21] (N= 25; 31) |
|
| All Doubles Pooled Strains [Day 0] (N= 30; 32) |
|
| All Doubles Pooled Strains [Day 21] (N= 25; 31) |
|
| CD40L A/Solomon Islands [Day 0] (N= 30; 32) |
|
| CD40L A/Solomon Islands [Day 21] (N= 25; 31) |
|
| CD40L A/Wisconsin [Day 0] (N= 30; 32) |
|
| CD40L A/Wisconsin [Day 21] (N= 25; 31) |
|
| CD40L B/Malaysia [Day 0] (N= 30; 32) |
|
| CD40L B/Malaysia [Day 21] (N= 25; 31) |
|
| CD40L Pooled Strains [Day 0] (N= 30; 32) |
|
| CD40L Pooled Strains [Day 21] (N= 25; 31) |
|
| IFN-γ A/Solomon Islands [Day 0] (N= 30; 32) |
|
| IFN-γ A/Solomon Islands [Day 21] (N= 25; 31) |
|
| IFN-γ A/Wisconsin [Day 0] (N= 30; 32) |
|
| IFN-γ A/Wisconsin [Day 21] (N= 25; 31) |
|
| IFN-γ B/Malaysia [Day 0] (N= 30; 32) |
|
| IFN-γ B/Malaysia [Day 21] (N= 25; 31) |
|
| IFN-γ Pooled Strains [Day 0] (N= 30; 32) |
|
| IFN-γ Pooled Strains [Day 21] (N= 25; 31) |
|
| IL-2 A/Solomon Islands [Day 0] (N= 30; 32) |
|
| IL-2 A/Solomon Islands [Day 21] (N= 25; 31) |
|
| IL-2 A/Wisconsin [Day 0] (N= 30; 32) |
|
| IL-2 A/Wisconsin [Day 21] (N= 25; 31) |
|
| IL-2 B/Malaysia [Day 0] (N= 30; 32) |
|
| IL-2 B/Malaysia [Day 21] (N= 25; 31) |
|
| IL-2 Pooled Strains [Day 0] (N= 30; 32) |
|
| IL-2 Pooled Strains [Day 21] (N= 25; 31) |
|
| TNF-α A/Solomon Islands [Day 0] (N= 30; 32) |
|
| TNF-α A/Solomon Islands [Day 21] (N= 25; 31) |
|
| TNF-α A/Wisconsin [Day 0] (N= 30; 32) |
|
| TNF-α A/Wisconsin [Day 21] (N= 25; 31) |
|
| TNF-α B/Malaysia [Day 0] (N= 30; 32) |
|
| TNF-α B/Malaysia [Day 21] (N= 25; 31) |
|
| TNF-α Pooled Strains [Day 0] (N= 30; 32) |
|
| TNF-α Pooled Strains [Day 21] (N= 25; 31) |
|
| All Doubles A/Wisconsin [Day 0] (N= 29; 32) |
|
| All Doubles A/Wisconsin [Day 21] (N= 25; 31) |
|
| All Doubles B/Malaysia [Day 0] (N= 29; 32) |
|
| All Doubles B/Malaysia [Day 21] (N= 25; 31) |
|
| All Doubles Pooled Strains [Day 0] (N= 29; 32) |
|
| All Doubles Pooled Strains [Day 21] (N= 24; 31) |
|
| CD40L A/Solomon Islands [Day 0] (N= 30; 32) |
|
| CD40L A/Solomon Islands [Day 21] (N= 25; 31) |
|
| CD40L A/Wisconsin [Day 0] (N= 29; 32) |
|
| CD40L A/Wisconsin [Day 21] (N= 25; 31) |
|
| CD40L B/Malaysia [Day 0] (N= 29; 32) |
|
| CD40L B/Malaysia [Day 21] (N= 25; 31) |
|
| CD40L Pooled Strains [Day 0] (N= 29; 32) |
|
| CD40L Pooled Strains [Day 21] (N= 24; 31) |
|
| IFN-γ A/Solomon Islands [Day 0] (N= 30; 32) |
|
| IFN-γ A/Solomon Islands [Day 21] (N= 25; 31) |
|
| IFN-γ A/Wisconsin [Day 0] (N= 29; 32) |
|
| IFN-γ A/Wisconsin [Day 21] (N= 25; 31) |
|
| IFN-γ B/Malaysia [Day 0] (N= 29; 32) |
|
| IFN-γ B/Malaysia [Day 21] (N= 25; 31) |
|
| IFN-γ Pooled Strains [Day 0] (N= 29; 32) |
|
| IFN-γ Pooled Strains [Day 21] (N= 24; 31) |
|
| IL-2 A/Solomon Islands [Day 0] (N= 30; 32) |
|
| IL-2 A/Solomon Islands [Day 21] (N= 25; 31) |
|
| IL-2 A/Wisconsin [Day 0] (N= 29; 32) |
|
| IL-2 A/Wisconsin [Day 21] (N= 25; 31) |
|
| IL-2 B/Malaysia [Day 0] (N= 29; 32) |
|
| IL-2 B/Malaysia [Day 21] (N= 25; 31) |
|
| IL-2 Pooled Strains [Day 0] (N= 29; 32) |
|
| IL-2 Pooled Strains [Day 21] (N= 24; 31) |
|
| TNF-α A/Solomon Islands [Day 0] (N= 30; 32) |
|
| TNF-α A/Solomon Islands [Day 21] (N= 25; 31) |
|
| TNF-α A/Wisconsin [Day 0] (N= 29; 32) |
|
| TNF-α A/Wisconsin [Day 21] (N= 25; 31) |
|
| TNF-α B/Malaysia [Day 0] (N= 29; 32) |
|
| TNF-α B/Malaysia [Day 21] (N= 25; 31) |
|
| TNF-α Pooled Strains [Day 0] (N= 29; 32) |
|
| TNF-α Pooled Strains [Day 21] (N= 24; 31) |
|