Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004734-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Experimental | Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
|
| GSK1562902A 12 to 24 M Group | Experimental | Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
|
| GSK1562902A 24 to 36 M Group | Experimental | Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' investigational vaccine GSK1562902A | Biological | Three intramuscular injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192. | At Day 192 |
| Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). | At Day 192 |
| Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. | At Day 192 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall. | At Day 0, Day 42, Day 182, Day 192 and Day 364 |
| Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Garran | Australian Capital Territory | 2606 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24973461 | Background | Nolan T, Izurieta P, Lee BW, Chan PC, Marshall H, Booy R, Drame M, Vaughn DW. Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children<3 years of age. J Infect Dis. 2014 Dec 1;210(11):1800-10. doi: 10.1093/infdis/jiu359. Epub 2014 Jun 27. |
| 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 |
|---|---|---|---|
| 109825 | Annotated Case Report Form | 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.
Not provided
Not provided
Not provided
Not provided
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK1562902A 6 to 12 M Group | Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| FG001 | GSK1562902A 12 to 24 M Group | Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| FG002 | GSK1562902A 24 to 36 M Group | Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK1562902A 6 to 12 M Group | Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| BG001 | GSK1562902A 12 to 24 M Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192. | The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 192 |
|
Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
Not provided
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 | GSK1562902A 6 to 12 M Group | Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
Not provided
Not provided
Not provided
Not provided
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall. |
| At Day 0, Day 182, Day 192 and Day 364 |
| Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10. | At Day 0, Day 42, Day 182, Day 192 and Day 364 |
| Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10. | At Day 0, Day 182, Day 192 and Day 364 |
| Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. | At Day 42, Day 182, Day 192 and Day 364 |
| Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures. | At Day 182 and Day 364 |
| Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. | At Day 0, Day 42, Day 182, Day 192 and Day 364 |
| Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures. | Day 0, Day 182 and Day 364 |
| Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). | At Day 42, Day 182, Day 192 and Day 364 |
| Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures. | Day 182 and Day 364 |
| Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer. | At Day 192 and Day 364 |
| Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer. | At Day 192 and Day 364 |
| Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28 | Day 0, Day 42, Day 182, Day 192 and Day 364 |
| Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28. | Day 0, Day 182, Day 192 and Day 364 |
| Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). | Day 0, Day 42, Day 182, Day 192 and Day 364 |
| Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). | Day 0, Day 182, Day 192 and Day 364 |
| Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0) | At Day 42, Day 182, Day 192 and Day 364 |
| Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0) | At Day 182, Day 192 and Day 364 |
| Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182) | At Day 192 and Day 364 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful. | During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination. | During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) |
| Number of Subjects With 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. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. | During the entire study period (from Day 0 to Day 364) |
| Number of Subjects With Potential Immune-mediated Disease (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | During the entire study period (from day 0 to Day 364) |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination. | During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203) |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination. | During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266) |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed included 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 Day 0 to 364) |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| GSK Investigational Site | North Adelaide | South Australia | 5006 | Australia |
| GSK Investigational Site | Carlton | Victoria | 3053 | Australia |
| GSK Investigational Site | Singapore | 119074 | Singapore |
| GSK Investigational Site | Singapore | 228510 | Singapore |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109825 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109825 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109825 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109825 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109825 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109825 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| BG002 | GSK1562902A 24 to 36 M Group | Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | GSK1562902A 12 to 24 M Group | Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| OG002 | GSK1562902A 24 to 36 M Group | Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| OG003 | GSK1562902A Group | Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
|
|
| Primary | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). | The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 192 |
|
|
|
| Primary | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. | The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 192 |
|
|
|
| Secondary | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0, Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 0, Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 0, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 182 and Day 364 |
|
|
|
| Secondary | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 0, Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0 and Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | Day 0, Day 182 and Day 364 |
|
|
|
| Secondary | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 182 and Day 364 |
|
|
|
| Secondary | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 192 and Day 364 |
|
|
|
| Secondary | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28 | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | Day 0, Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28. | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | Day 0, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 0, Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 0, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0) | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 42, Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0) | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 182, Day 192 and Day 364 |
|
|
|
| Secondary | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182) | The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | At Day 192 and Day 364 |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) |
|
|
|
| Secondary | Number of Subjects With 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. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Day 364) |
|
|
|
| Secondary | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During the entire study period (from day 0 to Day 364) |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203) |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266) |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed included 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 (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to 364) |
|
|
|
| 0 |
| 46 |
| 5 |
| 46 |
| 45 |
| 46 |
| EG001 | GSK1562902A 12 to 24 M Group | Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. | 0 | 34 | 4 | 34 | 32 | 34 |
| EG002 | GSK1562902A 24 to 36 M Group | Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. | 0 | 33 | 0 | 33 | 33 | 33 |
| Bronchiolitis | Infections and infestations | Systematic Assessment |
|
| Gastritis viral | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Body temperature increased | Investigations | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | Systematic Assessment |
|
| Candidiasis | Infections and infestations | Systematic Assessment |
|
| Chalazion | Eye disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Choking sensation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Croup infectious | Infections and infestations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Injection site haematoma | General disorders | Systematic Assessment |
|
| Injection site induration | General disorders | Systematic Assessment |
|
| Injection site rash | General disorders | Systematic Assessment |
|
| Injection site scab | General disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Otitis media | Infections and infestations | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Roseola | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Varicella | Infections and infestations | Systematic Assessment |
|
| Viral rash | Infections and infestations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | 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 |
|
| A/Indonesia/05/2005.HA [Day 42] |
|
|
| A/Indonesia/05/2005.HA [Day 182] |
|
|
| A/Indonesia/05/2005.HA [Day 192] |
|
|
| A/Indonesia/05/2005.HA [Day 364] |
|
|
|
| A/turkey/Turkey/01/2005.HA [Day 182] |
|
|
| A/turkey/Turkey/01/2005.HA [Day 192] |
|
|
| A/turkey/Turkey/01/2005.HA [Day 364] |
|
|
|
| A/Indonesia/05/2005.HA [Day 42] |
|
|
| A/Indonesia/05/2005.HA [Day 182] |
|
|
| A/Indonesia/05/2005.HA [Day 192] |
|
|
| A/Indonesia/05/2005.HA [Day 364] |
|
|
|
| A/turkey/Turkey/01/2005.HA [Day 182] 83 |
|
|
| A/turkey/Turkey/01/2005.HA [Day 192] |
|
|
| A/turkey/Turkey/01/2005.HA [Day 364] |
|
|
|
| A/Indonesia/05/2005.HA [Day 182] |
|
|
| A/Indonesia/05/2005.HA [Day 192] |
|
|
| A/Indonesia/05/2005.HA [Day 364] |
|
|
|
| A/turkey/Turkey/1/2005 H5N1 (Day 364) |
|
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 42] |
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 182] |
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 192] |
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 364] |
|
|
|
| A/turkey/Turkey/1/2005 H5N1.HA [Day 182] |
|
|
| A/turkey/Turkey/1/2005 H5N1.HA [Day 364] |
|
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 182] |
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 192] |
|
|
| A/Indonesia/05/2005 H5N1.HA [Day 364] |
|
|
|
| A/turkey/Turkey/1/2005 H5N1.HA [Day 364] |
|
|
|
| A/turkey/Turkey/01/2005 H5N1.HA [Day 364] |
|
|
|
| A/turkey/Turkey/01/2005 H5N1.HA [Day 364] |
|
|
|
| Flu A/Ind/05/05 (H5N1) [Day 42] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 182] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 192] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 364] |
|
|
|
| Flu A/Turk/01/05 (H5N1) [Day 182] |
|
|
| Flu A/Turk/01/05 (H5N1) [Day 192] |
|
|
| Flu A/Turk/01/05 (H5N1) [Day 364] |
|
|
|
| Flu A/Ind/05/05 (H5N1) [Day 42] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 182] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 192] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 364] |
|
|
|
| Flu A/Turk/01/05 (H5N1) [Day 182] |
|
|
| Flu A/Turk/01/05 (H5N1) [Day 192] |
|
|
| Flu A/Turk/01/05 (H5N1) [Day 364] |
|
|
|
| Flu A/Ind/05/05 (H5N1) [Day 182] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 192] |
|
|
| Flu A/Ind/05/05 (H5N1) [Day 364] |
|
|
|
| Flu A/Turk/01/05 (H5N1) [Day 192] |
|
|
| Flu A/Turk/01/05 (H5N1) [Day 364] |
|
|
|
| Flu A/Turk/01/05 (H5N1) [Day 364] |
|
|
|
| Grade 3 Pain Dose 1 |
|
|
| Any Redness Dose 1 |
|
|
| Grade 3 Redness Dose 1 |
|
|
| Any Swelling Dose 1 |
|
|
| Grade 3 Swelling Dose 1 |
|
|
| Any Pain Dose 2 |
|
|
| Grade 3 Pain Dose 2 |
|
|
| Any Redness Dose 2 |
|
|
| Grade 3 Redness Dose 2 |
|
|
| Any Swelling Dose 2 |
|
|
| Grade 3 Swelling Dose 2 |
|
|
| Any Pain Dose 3 |
|
|
| Grade 3 Pain Dose 3 |
|
|
| Any Redness Dose 3 |
|
|
| Grade 3 Redness Dose 3 |
|
|
| Any Swelling Dose 3 |
|
|
| Grade 3 Swelling Dose 3 |
|
|
| Any Pain Across doses |
|
|
| Grade 3 Pain Across doses |
|
|
| Any Redness Across doses |
|
|
| Grade 3 Redness Across doses |
|
|
| Any Swelling Across doses |
|
|
| Grade 3 Swelling Across doses |
|
|
|
| Grade 3 Diarrhoea/vomiting Dose 1 |
|
|
| Related Diarrhoea/vomiting Dose 1 |
|
|
| Any Drowsiness Dose 1 |
|
|
| Grade 3 Drowsiness Dose 1 |
|
|
| Related Drowsiness Dose 1 |
|
|
| Any Irritability/fussiness Dose 1 |
|
|
| Grade 3 Irritability/fussiness Dose 1 |
|
|
| Related Irritability/fussiness Dose 1 |
|
|
| Any Loss of appetite Dose 1 |
|
|
| Grade 3 Loss of appetite Dose 1 |
|
|
| Related Loss of appetite Dose 1 |
|
|
| Any Fever (Axillary) Dose 1 |
|
|
| Grade 3 Fever (Axillary) Dose 1 |
|
|
| Related Fever (Axillary) Dose 1 |
|
|
| Any Diarrhoea/vomiting Dose 2 |
|
|
| Grade 3 Diarrhoea/vomiting Dose 2 |
|
|
| Related Diarrhoea/vomiting Dose 2 |
|
|
| Any Drowsiness Dose 2 |
|
|
| Grade 3 Drowsiness Dose 2 |
|
|
| Related Drowsiness Dose 2 |
|
|
| Any Irritability/fussiness Dose 2 |
|
|
| Grade 3 Irritability/fussiness Dose 2 |
|
|
| Related Irritability/fussiness Dose 2 |
|
|
| Any Loss of appetite Dose 2 |
|
|
| Grade 3 Loss of appetite Dose 2 |
|
|
| Related Loss of appetite Dose 2 |
|
|
| Any Fever (Axillary) Dose 2 |
|
|
| Grade 3 Fever (Axillary) Dose 2 |
|
|
| Related Fever (Axillary) Dose 2 |
|
|
| Any Diarrhoea/vomiting Dose 3 |
|
|
| Grade 3 Diarrhoea/vomiting Dose 3 |
|
|
| Related Diarrhoea/vomiting Dose 3 |
|
|
| Any Drowsiness Dose 3 |
|
|
| Grade 3 Drowsiness Dose 3 |
|
|
| Related Drowsiness Dose 3 |
|
|
| Any Irritability/fussiness Dose 3 |
|
|
| Grade 3 Irritability/fussiness Dose 3 |
|
|
| Related Irritability/fussiness Dose 3 |
|
|
| Any Loss of appetite Dose 3 |
|
|
| Grade 3 Loss of appetite Dose 3 |
|
|
| Related Loss of appetite Dose 3 |
|
|
| Any Fever (Axillary) Dose 3 |
|
|
| Grade 3 Fever (Axillary) Dose 3 |
|
|
| Related Fever (Axillary) Dose 3 |
|
|
| Any Diarrhoea/vomiting Across doses |
|
|
| Grade 3 Diarrhoea/vomiting Across doses |
|
|
| Related Diarrhoea/vomiting Across doses |
|
|
| Any Drowsiness Across doses |
|
|
| Grade 3 Drowsiness Across doses |
|
|
| Related Drowsiness Across doses |
|
|
| Any Irritability/fussiness Across doses |
|
|
| Grade 3 Irritability/fussiness Across doses |
|
|
| Related Irritability/fussiness Across doses |
|
|
| Any Loss of appetite Across doses |
|
|
| Grade 3 Loss of appetite Across doses |
|
|
| Related Loss of appetite Across doses |
|
|
| Any Fever (Axillary) Across doses |
|
|
| Grade 3 Fever (Axillary) Across doses |
|
|
| Related Fever (Axillary) Across doses |
|
|
| Grade 3 AE(s) |
|
| Related AE(s) |
|
| Grade 3 AE(s) |
|
| Related AE(s) |
|