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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004517-14 | EudraCT Number |
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The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influsplit SSW® 2005/2006 6-9 years Group | Experimental | Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW® 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2). |
|
| Influsplit SSW® 2005/2006 10-13 years Group | Active Comparator | Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW® 2005/2006 vaccine at Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influsplit SSW® 2005/2006 | Biological | Study influenza vaccine was administered intramuscularly in the non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years | Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) |
| Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years | A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. |
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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 | Würzburg | Bavaria | 97070 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18022736 | Background | Schmidt-Ott R, Schwarz T, Haase R, Sander H, Walther U, Fourneau M, Htun-Myint L, Sanger R, Schuster V. Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine. 2007 Dec 21;26(1):32-40. doi: 10.1016/j.vaccine.2007.10.049. Epub 2007 Nov 9. |
| 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 |
|---|---|---|---|
| 106252 | Dataset Specification | 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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This study was conducted by a principal investigator and 22 investigators in 18 centers in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Influsplit SSW 2005/2006 6-9 Years Group | Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2). |
| FG001 | Influsplit SSW 2005/2006 10-13 Years Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| 21 days post-vaccination (Day 21) |
| SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 21 days post-vaccination (Day 21) |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 21 days post-vaccination (Day 21) |
| Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years | Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre < 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 21 days post-vaccination (Day 21) |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | 21 days post-vaccination (Day 21) |
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 4-day (Day 0-3) post-vaccination period following each dose and across doses |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination. | During the 4-day (Day 0-3) post-vaccination period following each dose and across doses |
| Number of Subjects With Unsolicited Adverse Events. | 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. | During 31 days after the study vaccine dose (Day 0-30) |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group |
| Bützow |
| Mecklenburg-Vorpommern |
| 18246 |
| Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18106 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18109 | Germany |
| GSK Investigational Site | Bischofswerda | Saxony | 01877 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01067 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01159 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01169 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04178 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04317 | Germany |
| GSK Investigational Site | Wurzen | Saxony | 04808 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Niebüll | Schleswig-Holstein | 25899 | Germany |
| GSK Investigational Site | Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | 10999 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106252 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106252 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106252 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106252 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106252 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Influsplit SSW 2005/2006 6-9 Years Group | Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2). |
| BG001 | Influsplit SSW 2005/2006 10-13 Years Group | Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years | Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) |
|
|
| |||||||||||||||||||||||||||
| Primary | Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years | A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Count of Participants | Participants | 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) |
|
| |||||||||||||||||||||||||||||
| Secondary | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Geometric Mean | 95% Confidence Interval | Titres | 21 days post-vaccination (Day 21) |
|
| ||||||||||||||||||||||||||||
| Secondary | SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | 21 days post-vaccination (Day 21) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Count of Participants | Participants | 21 days post-vaccination (Day 21) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years | Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre < 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Count of Participants | Participants | 21 days post-vaccination (Day 21) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed. | Posted | Count of Participants | Participants | 21 days post-vaccination (Day 21) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) post-vaccination period following each dose and across doses |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) post-vaccination period following each dose and across doses |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Unsolicited Adverse Events. | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. | Posted | Count of Participants | Participants | During 31 days after the study vaccine dose (Day 0-30) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. | Posted | Count of Participants | Participants | During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group |
|
|
Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.
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 | Influsplit SSW 2005/2006 6-9 Years Group | Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2). | 0 | 110 | 3 | 110 | 100 | 110 |
| EG001 | Influsplit SSW 2005/2006 10-13 Years Group | Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0. | 0 | 114 | 0 | 114 | 90 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hereditary fructose intolerance | Congenital, familial and genetic disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Lice infestation | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Otosalpingitis | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA 9.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
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| Not Specified |
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| A/New York (H3N2), Dose 1 |
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| A/New York (H3N2), Dose 2 |
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| B/Jiangsu, Dose 1 |
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| B/Jiangsu, Dose 2 |
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