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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020312-12 | EudraCT Number |
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The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.
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The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2584786A vaccine 1 dose of Formulation A1 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
|
| GSK2584786A vaccine 2 doses of Formulation A1 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
|
| GSK2584786A vaccine 1 dose of Formulation A2 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
|
| GSK2584786A vaccine 2 doses of Formulation A2 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
|
| GSK2584786A vaccine 1 dose of Formulation A3 Group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Bio's influenza vaccine GSK2584786A, different formulations | Biological | Intramuscular injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Haemagglutination-inhibition (HI) Antibody Titers | Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains. | at Day 28/ Day 56 |
| Serum Neutralizing Antibody Titers | at Day 28/ Day 56 | |
| Geometric Mean Number of All-CD4 Cytokine Positive Cells | Geometric mean of the number of CD4 cytokine positive T cells per million T cells. | at Day 28/ Day 56 |
| Number of Subjects Reporting Fever of at Least Grade 2 or Higher | Grade 2 fever was defined as axillary temperature above 38 degrees Celcius. | Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Serum HI Antibody Titers | Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains. | on Days 0, 28/56 and 180 |
| Serum Neutralising Antibody Titers |
Not provided
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Seville | 41013 | Spain |
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Since this study was prematurely terminated (not because of safety issues or lack of immunogenicity but for logistic reasons) only 4 of 1120 planned subjects were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK2584786A Vaccine 1 Dose of Formulation A1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
| FG001 | GSK2584786A Vaccine 2 Doses of Formulation A1 Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
|
| GSK2584786A vaccine 2 doses of Formulation A3 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
|
| GSK2584786A vaccine 1 dose of Formulation B1 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
|
| GSK2584786A vaccine 2 doses of Formulation B1 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
|
| GSK2584786A vaccine 1 dose of Formulation B2 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
|
| GSK2584786A vaccine 2 doses of Formulation B2 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
|
| GSK2584786A vaccine 1 dose of Formulation B3 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
|
| GSK2584786A vaccine 2 doses of Formulation B3 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
|
| GSK2321138A vaccine Group | Experimental | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
|
| Fluarix Group | Active Comparator | Subjects received 2 doses of Fluarix Vaccine. |
|
| GSK Bio's influenza vaccine GSK2321138A | Biological | Intramuscular injections |
|
| Fluarixâ„¢ | Biological | Intramuscular injections |
|
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
| on Days 0, 28/56 and 180 |
| Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite. | during a 7 day follow-up period (Day 0 to 6) after any vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | within 28 days (Day 0 to Day 27) after any vaccination |
| Number of Subjects Reporting Adverse Events With Medically Attended Visits | A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. | From Day 0 to 179 |
| Number of Subjects Reporting Potential Immune-mediated Diseases | Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. | From Day 0 to 179 |
| Number of Subjects Reporting Serious Adverse Events | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | From Day 0 to 179 |
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
| FG002 | GSK2584786A Vaccine 1 Dose of Formulation A2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| FG003 | GSK2584786A Vaccine 2 Doses of Formulation A2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| FG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| FG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| FG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| FG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| FG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| FG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| FG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| FG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| FG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| FG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK2584786A Vaccine 1 Dose of Formulation A1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
| BG001 | GSK2584786A Vaccine 2 Doses of Formulation A1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
| BG002 | GSK2584786A Vaccine 1 Dose of Formulation A2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| BG003 | GSK2584786A Vaccine 2 Doses of Formulation A2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| BG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| BG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| BG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| BG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| BG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| BG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| BG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| BG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| BG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| BG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
| BG014 | 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 | Months |
| |||||||||||||||
| Sex: Female, Male | 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 | Serum Haemagglutination-inhibition (HI) Antibody Titers | Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | at Day 28/ Day 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Serum Neutralizing Antibody Titers | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | at Day 28/ Day 56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Number of All-CD4 Cytokine Positive Cells | Geometric mean of the number of CD4 cytokine positive T cells per million T cells. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | at Day 28/ Day 56 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Fever of at Least Grade 2 or Higher | Grade 2 fever was defined as axillary temperature above 38 degrees Celcius. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum HI Antibody Titers | Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | on Days 0, 28/56 and 180 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Neutralising Antibody Titers | Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | on Days 0, 28/56 and 180 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | during a 7 day follow-up period (Day 0 to 6) after any vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Posted | Number | Subjects | within 28 days (Day 0 to Day 27) after any vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Adverse Events With Medically Attended Visits | A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | From Day 0 to 179 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Potential Immune-mediated Diseases | Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. | This outcome measure was not assessed for any of the study groups since the study was terminated prematurely. | Posted | From Day 0 to 179 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Serious Adverse Events | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Posted | Number | Subjects | From Day 0 to 179 |
|
Not provided
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 | GSK2584786A Vaccine 1 Dose of Formulation A1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. | 0 | 0 | 0 | 0 | ||
| EG001 | GSK2584786A Vaccine 2 Doses of Formulation A1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. | 0 | 0 | 0 | 0 | ||
| EG002 | GSK2584786A Vaccine 1 Dose of Formulation A2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. | 0 | 0 | 0 | 0 | ||
| EG003 | GSK2584786A Vaccine 2 Doses of Formulation A2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. | 0 | 0 | 0 | 0 | ||
| EG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. | 0 | 1 | 0 | 1 | ||
| EG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. | 0 | 0 | 0 | 0 | ||
| EG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. | 0 | 0 | 0 | 0 | ||
| EG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. | 0 | 1 | 1 | 1 | ||
| EG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. | 0 | 0 | 0 | 0 | ||
| EG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. | 0 | 0 | 0 | 0 | ||
| EG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. | 0 | 0 | 0 | 0 | ||
| EG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. | 0 | 1 | 1 | 1 | ||
| EG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). | 0 | 0 | 0 | 0 | ||
| EG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pyrexia | General disorders | Non-systematic Assessment |
| ||
| bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| herpes zoster | Infections and infestations | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
Not provided
| Male |
|
| OG004 |
| GSK2584786A Vaccine 1 Dose of Formulation A3 Group |
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
|
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
| OG004 | GSK2584786A Vaccine 1 Dose of Formulation A3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG005 | GSK2584786A Vaccine 2 Doses of Formulation A3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| OG006 | GSK2584786A Vaccine 1 Dose of Formulation B1 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG007 | GSK2584786A Vaccine 2 Doses of Formulation B1 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| OG008 | GSK2584786A Vaccine 1 Dose of Formulation B2 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG009 | GSK2584786A Vaccine 2 Doses of Formulation B2 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| OG010 | GSK2584786A Vaccine 1 Dose of Formulation B3 Group | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG011 | GSK2584786A Vaccine 2 Doses of Formulation B3 Group | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| OG012 | GSK2321138A Vaccine Group | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| OG013 | Fluarix Group | Subjects received 2 doses of Fluarix Vaccine. |
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