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| ID | Type | Description | Link |
|---|---|---|---|
| 111470 | |||
| 111471 | |||
| 111472 |
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Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule.
The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1562902A M6 Group | Experimental | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
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| GSK1562902A M12 Group | Experimental | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
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| GSK1562902A M36 Group | Experimental | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandemic influenza vaccine GSK1562902A | Biological | IM administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005. | At Month 12 + 21 days |
| Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005. | At Month 12 + 21 days |
| Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005. | At Month 36 + 21 days |
| Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005. | At Month 36 + 21 days |
| Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1). | At Month 12 + 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects for H5N1 HI Antibodies | Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 18, 24, 30 and 36 |
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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 | Hong Kong | Hong Kong | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24628789 | Derived | Gillard P, Chu DW, Hwang SJ, Yang PC, Thongcharoen P, Lim FS, Drame M, Walravens K, Roman F. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis. 2014 Mar 15;14:142. doi: 10.1186/1471-2334-14-142. |
| 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 |
|---|---|---|---|
| 111443 | 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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One enrolled subject was not administered a booster vaccination and hence not considered to have started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1562902A M6 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| FG001 | GSK1562902A M12 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| FG002 | GSK1562902A M36 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Months 12-18 |
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| Months 24-30 |
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| Months 36-42 |
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| Months 42-48 |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1562902A M6 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| 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 |
| 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 Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 12 + 21 days |
|
SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination.
Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster 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 | GSK1562902A M6 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | 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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| Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 |
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1). |
| At Month 36 + 21 Days |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | GMFR, also known as 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 flu strain assessed was Flu A/Indonesia/05/2005. | At Month 12 + 21 days |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | GMFR, also known as 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 flu strain assessed was Flu A/Indonesia/05/2005. | At Month 36 +21 days |
| Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. | At Month 12 + 21 days |
| Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. | At Month 36 + 21 days |
| Number of Seropositive Subjects for H5N1 HI Antibodies |
Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| At Months 42 and 48 |
| Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 18, 24 and 30 |
| Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | Seroconversion 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 strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 18, 24 and 30 |
| Booster Vaccine Response for H5N1 HI Antibodies | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 36, 42 and 48 |
| Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | GMFR, also known as 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 18, 24, 30 |
| Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | GMFR, also known as 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 36, 42 and 48 |
| Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 18, 24 and 30 |
| Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 36, 42 and 48 |
| Titers for Serum Neutralizing Antibodies | Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 6/12, 6/12 + 21 days, 24, 36 and 48 |
| Booster Vaccine Response for Neutralizing Antibodies | Booster vaccine response was defined as: for pre-booster antibody titer < 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005. | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004. | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 |
| 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. | During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36 |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | 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. | During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36 |
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | During the entire study period (From Month 12 to Month 48) |
| Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005. | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
| Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004. | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
| Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 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 strain assessed was H5N1 A/Indonesia/05/2005. | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
| Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004. | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
| 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. | During the 30-day (Days 0-29) follow-up period after vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (From Month 12 up to Month 48) |
| Singapore |
| 308433 |
| Singapore |
| GSK Investigational Site | Singapore | 529889 | Singapore |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111443 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 111470 are summarised with studies 111443, 111471, and 111472 on the GSK Clinical Study Register. |
| 111443 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111443 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111443 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111443 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| BG001 | GSK1562902A M12 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| BG002 | GSK1562902A M36 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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 | Titers | At Month 12 + 21 days |
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| Primary | Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 36 + 21 days |
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| Primary | Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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 | Titers | At Month 36 + 21 days |
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| Primary | Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 12 + 21 days |
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| Primary | Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 36 + 21 Days |
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| Primary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | GMFR, also known as 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 flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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 | Fold change | At Month 12 + 21 days |
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| Primary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | GMFR, also known as 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 flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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 | Fold change | At Month 36 +21 days |
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| Primary | Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 12 + 21 days |
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| Primary | Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 36 + 21 days |
|
|
|
| Secondary | Number of Seropositive Subjects for H5N1 HI Antibodies | Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for persistence at Month 12-18 (M12-18) and at Month 24-30 (M24-30), which included all evaluable subjects not boosted (M12-18) and boosted (M24-30) at M12, not boosted at M12 but boosted at M6 or neither boosted at M6 nor at M12 (M24-30). | Posted | Count of Participants | Participants | At Months 18, 24, 30 and 36 |
|
|
|
| Secondary | Number of Seropositive Subjects for H5N1 HI Antibodies | Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Months 42 and 48 |
|
|
|
| Secondary | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12. | Posted | Count of Participants | Participants | At Months 18, 24 and 30 |
|
|
|
| Secondary | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | Seroconversion 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 strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12. | Posted | Count of Participants | Participants | At Months 18, 24 and 30 |
|
|
|
| Secondary | Booster Vaccine Response for H5N1 HI Antibodies | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Months 36, 42 and 48 |
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|
|
| Secondary | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | GMFR, also known as 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Months 18, 24, 30 |
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|
|
| Secondary | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | GMFR, also known as 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 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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 | Fold change | At Months 36, 42 and 48 |
|
|
|
| Secondary | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12. | Posted | Count of Participants | Participants | At Months 18, 24 and 30 |
|
|
|
| Secondary | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Months 36, 42 and 48 |
|
|
|
| Secondary | Titers for Serum Neutralizing Antibodies | Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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 | Titers | At Months 6/12, 6/12 + 21 days, 24, 36 and 48 |
|
|
|
| Secondary | Booster Vaccine Response for Neutralizing Antibodies | Booster vaccine response was defined as: for pre-booster antibody titer < 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 |
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|
|
| Secondary | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 |
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|
|
| Secondary | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36 |
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|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | 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. | The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who has their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36 |
|
|
|
| Secondary | Number of Subjects With Adverse Events of Specific Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (From Month 12 to Month 48) |
|
|
|
| Secondary | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | T-cells/million cells | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
|
|
|
| Secondary | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | T-cells/million cells | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
|
|
|
| Secondary | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 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 strain assessed was H5N1 A/Indonesia/05/2005. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | T-cells/million cells | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
|
|
|
| Secondary | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | T-cells/million cells | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 30-day (Days 0-29) follow-up period after vaccination |
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|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (From Month 12 up to Month 48) |
|
|
|
| 0 |
| 219 |
| 14 |
| 219 |
| 0 |
| 0 |
| EG001 | GSK1562902A M12 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. | 0 | 188 | 13 | 188 | 169 | 188 |
| EG002 | GSK1562902A M36 Group | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. | 0 | 437 | 28 | 437 | 336 | 437 |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Chest pain | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Choroidal detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Morton's neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Normal tension glaucoma | Eye disorders | MedDRA | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Salpingo-oophoritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Viith nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Induration | General disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | 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 |
| Male |
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| A/Indonesia/05/2005, Month 24 |
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| A/Indonesia/05/2005, Month 30 |
|
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| A/Indonesia/05/2005, Month 36 |
|
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| A/Vietnam/1194/2004, Month 18 |
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| A/Vietnam/1194/2004, Month 24 |
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| A/Vietnam/1194/2004, Month 30 |
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| A/Vietnam/1194/2004, Month 36 |
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| A/Indonesia/05/2005, Month 48 |
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| A/Vietnam/1194/2004, Month 42 |
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| A/Vietnam/1194/2004, Month 48 |
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| A/Indonesia/05/2005, Month 24 |
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| A/Indonesia/05/2005, Month 30 |
|
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| A/Vietnam/1194/2004, Month 18 |
|
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| A/Vietnam/1194/2004, Month 24 |
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| A/Vietnam/1194/2004, Month 30 |
|
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| A/Indonesia/05/2005, Month 30 |
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| A/Vietnam/1194/2004, Month 18 |
|
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| A/Vietnam/1194/2004, Month 24 |
|
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| A/Vietnam/1194/2004, Month 30 |
|
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| A/Indonesia/05/2005, Month 42 |
|
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| A/Indonesia/05/2005, Month 48 |
|
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| A/Vietnam/1194/2004, Month 36 |
|
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| A/Vietnam/1194/2004, Month 42 |
|
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| A/Vietnam/1194/2004, Month 48 |
|
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| A/Indonesia/05/2005, Month 24 |
|
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| A/Indonesia/05/2005, Month 30 |
|
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| A/Vietnam/1194/2004, Month 18 |
|
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| A/Vietnam/1194/2004, Month 24 |
|
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| A/Vietnam/1194/2004, Month 30 |
|
|
| A/Indonesia/05/2005, Month 42 |
|
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| A/Indonesia/05/2005, Month 48 |
|
|
| A/Vietnam/1194/2004, Month 36 |
|
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| A/Vietnam/1194/2004, Month 42 |
|
|
| A/Vietnam/1194/2004, Month 48 |
|
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| A/Indonesia/05/2005, Month 24 |
|
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| A/Indonesia/05/2005, Month 30 |
|
|
| A/Vietnam/1194/2004, Month 18 |
|
|
| A/Vietnam/1194/2004, Month 24 |
|
|
| A/Vietnam/1194/2004, Month 30 |
|
|
| A/Indonesia/05/2005, Month 42 |
|
|
| A/Indonesia/05/2005, Month 48 |
|
|
| A/Vietnam/1194/2004, Month 36 |
|
|
| A/Vietnam/1194/2004, Month 42 |
|
|
| A/Vietnam/1194/2004, Month 48 |
|
|
| A/Indonesia/05/2005, Month 6/12/36 + 21 days |
|
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| A/Indonesia/05/2005, Month 12 |
|
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| A/Indonesia/05/2005, Month 24 |
|
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| A/Indonesia/05/2005, Month 36 |
|
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| A/Indonesia/05/2005, Month 48 |
|
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| A/Vietnam/1194/2004, Month 6 |
|
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| A/Vietnam/1194/2004, Month 6/12/36 + 21 days |
|
|
| A/Vietnam/1194/2004, Month 12 |
|
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| A/Vietnam/1194/2004, Month 24 |
|
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| A/Vietnam/1194/2004, Month 36 |
|
|
| A/Vietnam/1194/2004, Month 48 |
|
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| A/Indonesia/05/2005, Month 24 |
|
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| A/Indonesia/05/2005, Month 36 |
|
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| A/Indonesia/05/2005, Month 48 |
|
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| A/Indonesia/05/2005, Month 6/12/36 + 21 days |
|
|
| A/Vietnam/1194/2004, Month 12 |
|
|
| A/Vietnam/1194/2004, Month 24 |
|
|
| A/Vietnam/1194/2004, Month 36 |
|
|
| A/Vietnam/1194/2004, Month 48 |
|
|
| A/Vietnam/1194/2004, Month 6/12/36 + 21 days |
|
|
| Month 12, ≥ 1:28 |
|
|
| Month 24, ≥ 1:28 |
|
|
| Month 36, ≥ 1:28 |
|
|
| Month 48, ≥ 1:28 |
|
|
| Month 6/12/36 + 21 days, ≥ 1:28 |
|
|
| Month 6, ≥ 1:56 |
|
|
| Month 12, ≥ 1:56 |
|
|
| Month 24, ≥ 1:56 |
|
|
| Month 36, ≥ 1:56 |
|
|
| Month 48, ≥ 1:56 |
|
|
| Month 6/12/36 + 21 days, ≥ 1:56 |
|
|
| Month 6, ≥ 1:112 |
|
|
| Month 12, ≥ 1:112 |
|
|
| Month 24, ≥ 1:112 |
|
|
| Month 36, ≥ 1:112 |
|
|
| Month 48, ≥ 1:112 |
|
|
| Month 6/12/36 + 21 days, ≥ 1:112 |
|
|
| Month 12, ≥ 1:28 |
|
|
| Month 24, ≥ 1:28 |
|
|
| Month 36, ≥ 1:28 |
|
|
| Month 48, ≥ 1:28 |
|
|
| Month 6/12/36 + 21 days, ≥ 1:28 |
|
|
| Month 6, ≥ 1:56 |
|
|
| Month 12, ≥ 1:56 |
|
|
| Month 24, ≥ 1:56 |
|
|
| Month 36, ≥ 1:56 |
|
|
| Month 48, ≥ 1:56 |
|
|
| Month 6/12/36 + 21 days, ≥ 1:56 |
|
|
| Month 6, ≥ 1:112 |
|
|
| Month 12, ≥ 1:112 |
|
|
| Month 24, ≥ 1:112 |
|
|
| Month 36, ≥ 1:112 |
|
|
| Month 48, ≥ 1:112 |
|
|
| Month 6/12/36 + 21 days, ≥ 1:112 |
|
|
| Any Induration |
|
| Grade 3 Induration |
|
| Any Pain |
|
| Grade 3 Pain |
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Related Arthralgia |
|
| Any Fatigue |
|
| Grade 3 Fatigue |
|
| Related Fatigue |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Myalgia |
|
| Grade 3 Myalgia |
|
| Related Myalgia |
|
| Any Shivering |
|
| Grade 3 Shivering |
|
| Related Shivering |
|
| Any Sweating |
|
| Grade 3 Sweating |
|
| Related Sweating |
|
| Any Temperature |
|
| Grade 3 Temperature |
|
| Related Temperature |
|
| CD4-All doubles, Month 12 |
|
|
| CD4-All doubles, Month 18 |
|
|
| CD4-All doubles, Month 24 |
|
|
| CD4-All doubles, Month 30 |
|
|
| CD4-All doubles, Month 36 |
|
|
| CD4-All doubles, Month 42 |
|
|
| CD4-All doubles, Month 48 |
|
|
| CD4-All doubles, Month 6/12/36 + 21 days |
|
|
| CD4-CD40L, Month 6 |
|
|
| CD4-CD40L, Month 12 |
|
|
| CD4-CD40L, Month 18 |
|
|
| CD4-CD40L, Month 24 |
|
|
| CD4-CD40L, Month 30 |
|
|
| CD4-CD40L, Month 36 |
|
|
| CD4-CD40L, Month 42 |
|
|
| CD4-CD40L, Month 48 |
|
|
| CD4-CD40L, Month 6/12/36 + 21 days |
|
|
| CD4-IFN-γ, Month 6 |
|
|
| CD4-IFN-γ, Month 12 |
|
|
| CD4-IFN-γ, Month 18 |
|
|
| CD4-IFN-γ, Month 24 |
|
|
| CD4-IFN-γ, Month 30 |
|
|
| CD4-IFN-γ, Month 36 |
|
|
| CD4-IFN-γ, Month 42 |
|
|
| CD4-IFN-γ, Month 48 |
|
|
| CD4-IFN-γ, Month 6/12/36 + 21 days |
|
|
| CD4-IL-2, Month 6 |
|
|
| CD4-IL-2, Month 12 |
|
|
| CD4-IL-2, Month 18 |
|
|
| CD4-IL-2, Month 24 |
|
|
| CD4-IL-2, Month 30 |
|
|
| CD4-IL-2, Month 36 |
|
|
| CD4-IL-2, Month 42 |
|
|
| CD4-IL-2, Month 48 |
|
|
| CD4-IL-2, Month 6/12/36 + 21 days |
|
|
| CD4-TNF-α, Month 6 |
|
|
| CD4-TNF-α, Month 12 |
|
|
| CD4-TNF-α, Month 18 |
|
|
| CD4-TNF-α, Month 24 |
|
|
| CD4-TNF-α, Month 30 |
|
|
| CD4-TNF-α, Month 36 |
|
|
| CD4-TNF-α, Month 42 |
|
|
| CD4-TNF-α, Month 48 |
|
|
| CD4-TNF-α, Month 6/12/36 + 21 days |
|
|
| CD4-All doubles, Month 12 |
|
|
| CD4-All doubles, Month 18 |
|
|
| CD4-All doubles, Month 24 |
|
|
| CD4-All doubles, Month 30 |
|
|
| CD4-All doubles, Month 36 |
|
|
| CD4-All doubles, Month 42 |
|
|
| CD4-All doubles, Month 48 |
|
|
| CD4-All doubles, Month 6/12/36 + 21 days |
|
|
| CD4-CD40L, Month 6 |
|
|
| CD4-CD40L, Month 12 |
|
|
| CD4-CD40L, Month 18 |
|
|
| CD4-CD40L, Month 24 |
|
|
| CD4-CD40L, Month 30 |
|
|
| CD4-CD40L, Month 36 |
|
|
| CD4-CD40L, Month 42 |
|
|
| CD4-CD40L, Month 48 |
|
|
| CD4-CD40L, Month 6/12/36 + 21 days |
|
|
| CD4-IFN-γ, Month 6 |
|
|
| CD4-IFN-γ, Month 12 |
|
|
| CD4-IFN-γ, Month 18 |
|
|
| CD4-IFN-γ, Month 24 |
|
|
| CD4-IFN-γ, Month 30 |
|
|
| CD4-IFN-γ, Month 36 |
|
|
| CD4-IFN-γ, Month 42 |
|
|
| CD4-IFN-γ, Month 48 |
|
|
| CD4-IFN-γ, Month 6/12/36 + 21 days |
|
|
| CD4-IL-2, Month 6 |
|
|
| CD4-IL-2, Month 12 |
|
|
| CD4-IL-2, Month 18 |
|
|
| CD4-IL-2, Month 24 |
|
|
| CD4-IL-2, Month 30 |
|
|
| CD4-IL-2, Month 36 |
|
|
| CD4-IL-2, Month 42 |
|
|
| CD4-IL-2, Month 48 |
|
|
| CD4-IL-2, Month 6/12/36 + 21 days |
|
|
| CD4-TNF-α, Month 6 |
|
|
| CD4-TNF-α, Month 12 |
|
|
| CD4-TNF-α, Month 18 |
|
|
| CD4-TNF-α, Month 24 |
|
|
| CD4-TNF-α, Month 30 |
|
|
| CD4-TNF-α, Month 36 |
|
|
| CD4-TNF-α, Month 42 |
|
|
| CD4-TNF-α, Month 48 |
|
|
| CD4-TNF-α, Month 6/12/36 + 21 days |
|
|
| CD8-All doubles, Month 12 |
|
|
| CD8-All doubles, Month 18 |
|
|
| CD8-All doubles, Month 24 |
|
|
| CD8-All doubles, Month 30 |
|
|
| CD8-All doubles, Month 36 |
|
|
| CD8-All doubles, Month 42 |
|
|
| CD8-All doubles, Month 48 |
|
|
| CD8-All doubles, Month 6/12/36 + 21 days |
|
|
| CD8-CD40L, Month 6 |
|
|
| CD8-CD40L, Month 12 |
|
|
| CD8-CD40L, Month 18 |
|
|
| CD8-CD40L, Month 24 |
|
|
| CD8-CD40L, Month 30 |
|
|
| CD8-CD40L, Month 36 |
|
|
| CD8-CD40L, Month 42 |
|
|
| CD8-CD40L, Month 48 |
|
|
| CD8-CD40L, Month 6/12/36 + 21 days |
|
|
| CD8-IFN-γ, Month 6 |
|
|
| CD8-IFN-γ, Month 12 |
|
|
| CD8-IFN-γ, Month 18 |
|
|
| CD8-IFN-γ, Month 24 |
|
|
| CD8-IFN-γ, Month 30 |
|
|
| CD8-IFN-γ, Month 36 |
|
|
| CD8-IFN-γ, Month 42 |
|
|
| CD8-IFN-γ, Month 48 |
|
|
| CD8-IFN-γ, Month 6/12/36 + 21 days |
|
|
| CD8-IL-2, Month 6 |
|
|
| CD8-IL-2, Month 12 |
|
|
| CD8-IL-2, Month 18 |
|
|
| CD8-IL-2, Month 24 |
|
|
| CD8-IL-2, Month 30 |
|
|
| CD8-IL-2, Month 36 |
|
|
| CD8-IL-2, Month 42 |
|
|
| CD8-IL-2, Month 48 |
|
|
| CD8-IL-2, Month 6/12/36 + 21 days |
|
|
| CD8-TNF-α, Month 6 |
|
|
| CD8-TNF-α, Month 12 |
|
|
| CD8-TNF-α, Month 18 |
|
|
| CD8-TNF-α, Month 24 |
|
|
| CD8-TNF-α, Month 30 |
|
|
| CD8-TNF-α, Month 36 |
|
|
| CD8-TNF-α, Month 42 |
|
|
| CD8-TNF-α, Month 48 |
|
|
| CD8-TNF-α, Month 6/12/36 + 21 days |
|
|
| CD8-All doubles, Month 12 |
|
|
| CD8-All doubles, Month 18 |
|
|
| CD8-All doubles, Month 24 |
|
|
| CD8-All doubles, Month 30 |
|
|
| CD8-All doubles, Month 36 |
|
|
| CD8-All doubles, Month 42 |
|
|
| CD8-All doubles, Month 48 |
|
|
| CD8-All doubles, Month 6/12/36 + 21 days |
|
|
| CD8-CD40L, Month 6 |
|
|
| CD8-CD40L, Month 12 |
|
|
| CD8-CD40L, Month 18 |
|
|
| CD8-CD40L, Month 24 |
|
|
| CD8-CD40L, Month 30 |
|
|
| CD8-CD40L, Month 36 |
|
|
| CD8-CD40L, Month 42 |
|
|
| CD8-CD40L, Month 48 |
|
|
| CD8-CD40L, Month 6/12/36 + 21 days |
|
|
| CD8-IFN-γ, Month 6 |
|
|
| CD8-IFN-γ, Month 12 |
|
|
| CD8-IFN-γ, Month 18 |
|
|
| CD8-IFN-γ, Month 24 |
|
|
| CD8-IFN-γ, Month 30 |
|
|
| CD8-IFN-γ, Month 36 |
|
|
| CD8-IFN-γ, Month 42 |
|
|
| CD8-IFN-γ, Month 48 |
|
|
| CD8-IFN-γ, Month 6/12/36 + 21 days |
|
|
| CD8-IL-2, Month 6 |
|
|
| CD8-IL-2, Month 12 |
|
|
| CD8-IL-2, Month 18 |
|
|
| CD8-IL-2, Month 24 |
|
|
| CD8-IL-2, Month 30 |
|
|
| CD8-IL-2, Month 36 |
|
|
| CD8-IL-2, Month 42 |
|
|
| CD8-IL-2, Month 48 |
|
|
| CD8-IL-2, Month 6/12/36 + 21 days |
|
|
| CD8-TNF-α, Month 6 |
|
|
| CD8-TNF-α, Month 12 |
|
|
| CD8-TNF-α, Month 18 |
|
|
| CD8-TNF-α, Month 24 |
|
|
| CD8-TNF-α, Month 30 |
|
|
| CD8-TNF-α, Month 36 |
|
|
| CD8-TNF-α, Month 42 |
|
|
| CD8-TNF-α, Month 48 |
|
|
| CD8-TNF-α, Month 6/12/36 + 21 days |
|
|
| Related AE(s) |
|
|