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The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AREPANRIX-ADJUVANTED F1 2D GROUP | Experimental | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
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| AREPANRIX-ADJUVANTED F2 2D GROUP | Experimental | Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
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| AREPANRIX-ADJUVANTED F2 3D GROUP | Experimental | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
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| AREPANRIX-UNADJUVANTED F2 2D GROUP | Experimental | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' Influenza investigational vaccine GSK2340274A | Biological | One or two doses administered intramuscularly |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre | At Day 21 |
| Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 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 Day 0 and Day 21 |
| HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. | At Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titres were expressed as Geometric mean titers (GMTs). | At Day 0 and Day 42 |
| HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain |
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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 | Tartu | 50106 | Estonia | |||
| GSK Investigational Site |
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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 |
|---|---|---|---|
| 113883 | Clinical Study Report | 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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310 subjects were enrolled in the study, all of which were vaccinated and completed the Day 42 visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arepanrix-adjuvanted F1 2D Group | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| FG001 | Arepanrix-adjuvanted F2 2D Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| GSK Biologicals' Influenza investigational vaccine GSK2340273A | Biological | Two doses intramuscularly |
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| Placebo (saline) | Biological | One dose intramuscularly |
|
Antibody titres were expressed as GMTs.
| At Day 0 and Day 182 |
| HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titres were expressed as Geometric mean titers (GMTs). | At Days 0, 182 and 189 |
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. | At Day 42 |
| HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titers were expressed as GMTs. | At Day 0 and Day 21 |
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. | At Day 182 |
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity. | At Day 189 |
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity. | At Day 189 |
| The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. | At Day 0 and Day 42 |
| Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. | At Day 0 and Day 182 |
| Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | 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 Day 0, Day 182 and Day 189 |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | At Day 42 |
| GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | At Day 182 |
| GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | At Day 189 |
| GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | At Day 189 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity. | During the 7-day (Days 0-6) post-vaccination period following each dose |
| Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity | During the 7-day (Days 0-6) post-vaccination period following booster dose |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C. | During the 7-day (Days 0-6) post-vaccination period following each dose |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C. | During the 7-day (Days 0-6) post-vaccination period following booster dose |
| Number of Subjects Reporting Any Medically Attended Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. | During the entire study period (Days 0-364) following the first vaccination |
| Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. | During the entire study period (Days 0-364) following first vaccination |
| Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs). | At Days 0, 21, 42, 182 and 189 |
| Number of Subjects Reporting Any Unsolicited 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 was defined as any symptom regardless of intensity or relationship to vaccination. | During the 42-day (Days 0-41) follow up period after first vaccination. |
| Number of Subjects Reporting Any Unsolicited 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 was defined as any symptom regardless of intensity or relationship to vaccination. | During the 21-day (Days 0-20) follow-up period after booster vaccination. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs: 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. | During the entire study period (Day 0 to Day 364) |
| Cífer |
| 919 43 |
| Slovakia |
| GSK Investigational Site | Dolný Kubín | 026 01 | Slovakia |
| GSK Investigational Site | Dunajská Streda | 929 01 | Slovakia |
| GSK Investigational Site | Nová Dubnica | 018 51 | Slovakia |
| GSK Investigational Site | Nové Mesto nad Váhom | 915 01 | Slovakia |
| GSK Investigational Site | Púchov | 020 01 | Slovakia |
| GSK Investigational Site | Ružomberok | 034 01 | Slovakia |
| GSK Investigational Site | Trenčín | 911 01 | Slovakia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113883 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113883 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113883 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113883 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113883 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
| FG002 | Arepanrix-adjuvanted F2 3D Group | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
| FG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arepanrix-adjuvanted F1 2D Group | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| BG001 | Arepanrix-adjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| BG002 | Arepanrix-adjuvanted F2 3D Group | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
| BG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre | The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available. | Posted | Number | Subjects | At Day 21 |
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| Primary | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 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 ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available. | Posted | Number | Subjects | At Day 0 and Day 21 |
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| Primary | HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. | The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
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| Secondary | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titres were expressed as Geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 and Day 42 |
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| Secondary | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titres were expressed as GMTs. | The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 and Day 182 |
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| Secondary | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titres were expressed as Geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0, 182 and 189 |
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| Secondary | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. | The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available | Posted | Number | Subjects | At Day 42 |
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| Secondary | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Antibody titers were expressed as GMTs. | The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available. | Posted | Mean | 95% Confidence Interval | Titers | At Day 0 and Day 21 |
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| Secondary | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. | The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available | Posted | Number | Subjects | At Day 182 |
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| Secondary | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity. | The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available | Posted | Number | Subjects | At Day 189 |
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| Secondary | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity. | The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available | Posted | Number | Subjects | At Day 189 |
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| Secondary | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available | Posted | Number | Subjects | At Day 0 and Day 42 |
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| Secondary | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available | Posted | Number | Subjects | At Day 0 and Day 182 |
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| Secondary | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | 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 ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available | Posted | Number | Subjects | At Day 0, Day 182 and Day 189 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 42 |
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| Secondary | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 182 |
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| Secondary | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 189 |
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| Secondary | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. | The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 189 |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During the 7-day (Days 0-6) post-vaccination period following each dose |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During the 7-day (Days 0-6) post-vaccination period following booster dose |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During the 7-day (Days 0-6) post-vaccination period following each dose |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. Note: 1 subject moved out of the study area thereby withdrawing from the study. | Posted | Number | Subjects | During the 7-day (Days 0-6) post-vaccination period following booster dose |
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| Secondary | Number of Subjects Reporting Any Medically Attended Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Days 0-364) following the first vaccination |
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| Secondary | Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. | The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Days 0-364) following first vaccination |
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| Secondary | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs). | The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects. Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189. | Posted | Number | Subjects | At Days 0, 21, 42, 182 and 189 |
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| Secondary | Number of Subjects Reporting Any Unsolicited 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 was defined as any symptom regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During the 42-day (Days 0-41) follow up period after first vaccination. |
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| Secondary | Number of Subjects Reporting Any Unsolicited 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 was defined as any symptom regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects. Note: 1 subject moved out of the study area thereby withdrawing from the study. | Posted | Number | Subjects | During the 21-day (Days 0-20) follow-up period after booster vaccination. |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs: 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. | The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Day 0 to Day 364) |
|
SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arepanrix-adjuvanted F1 2D Group | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. | 2 | 66 | 60 | 66 | ||
| EG001 | Arepanrix-adjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. | 2 | 66 | 59 | 66 | ||
| EG002 | Arepanrix-adjuvanted F2 3D Group | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). | 1 | 68 | 67 | 68 | ||
| EG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. | 5 | 110 | 94 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the primary phase of the study |
|
| Swelling (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the Primary phase of the study |
|
| Redness | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. |
|
| Arthralgia (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study. |
|
| Fatigue (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study. |
|
| Headache (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the Primary phase of the study. |
|
| Myalgia (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study. |
|
| Shivering (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the Primary phase of the study. |
|
| Sweating (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE was reported during the Primary phase of the study. |
|
| Pain (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study |
|
| Swelling (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study. |
|
| Arthralgia (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the Primary phase of the study. |
|
| Fatigue (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE was reported during the Primary phase of the study. |
|
| Headache (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study. |
|
| Myalgia (Primary phase) | General disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the Primary phase of the study. |
|
| Shivering (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study. |
|
| Sweating (Booster phase) | General disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study. |
|
| Gastrointestinal (Primary phase) | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment | AE reported during the Primary phase of the study. |
|
| Gastrointestinal (Booster phase) | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study. |
|
| Fever | Infections and infestations | MedDRA 14.0 | Systematic Assessment | 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 |
| Arepanrix-unadjuvanted F2 2D Group |
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| Arepanrix-unadjuvanted F2 2D Group |
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 |
| Arepanrix-unadjuvanted F2 2D Group |
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| Arepanrix-unadjuvanted F2 2D Group |
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| Arepanrix-unadjuvanted F2 2D Group |
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| Arepanrix-unadjuvanted F2 2D Group |
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
| OG003 | Arepanrix-unadjuvanted F2 2D Group | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
|
|