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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012701-19 | EudraCT Number |
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This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Group 4 | Experimental |
| |
| Control Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine GSK2189242A (formulation 1) | Biological | Three doses will be administered intramuscularly, at Month 0, 2 and 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Fever > 40.0°C (Rectal Temperature) | The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported. | Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose) |
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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 | Chomutov | 43003 | Czechia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24699466 | Background | Prymula R, Pazdiora P, Traskine M, Ruggeberg JU, Borys D. Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: a phase II randomized clinical trial. Vaccine. 2014 May 23;32(25):3025-34. doi: 10.1016/j.vaccine.2014.03.066. Epub 2014 Apr 1. |
| 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 |
|---|---|---|---|
| 113171 | Individual Participant Data Set | 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.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pneumococcal vaccine GSK2189242A (formulation 2) | Biological | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
|
| Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) | Biological | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
|
| Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4) | Biological | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
|
| Pneumococcal vaccine GSK1024850A | Biological | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
|
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose) |
| 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | During the 31-day (Days 0-30) follow-up period after each primary dose |
| 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | During the 31-day (Days 0-30) follow-up period after the booster dose |
| 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 starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7) |
| Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL. | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
| Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL). | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8. | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
| Antibody Concentrations to Protein D (Anti-PD) | Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL). | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
| Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140. | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
| Děčín |
| 405 01 |
| Czechia |
| GSK Investigational Site | Náchod | 547 01 | Czechia |
| GSK Investigational Site | Odolena Voda | 25070 | Czechia |
| GSK Investigational Site | Ostrava - Poruba | 70868 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Pilsen | 305 99 | Czechia |
| GSK Investigational Site | Prague | 140 00 | Czechia |
| GSK Investigational Site | Prague | 1600 | Czechia |
| GSK Investigational Site | Znojmo | 669 00 | Czechia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113171 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113171 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113171 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113171 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| FG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| FG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| FG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| BG001 | GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| BG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| BG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| BG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| BG005 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination |
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| Primary | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose) |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose) |
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| 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) follow-up period after each primary dose |
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| 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) follow-up period after the booster dose |
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| 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, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7) |
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| Secondary | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | LU/mL | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
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| Secondary | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
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| Secondary | Antibody Concentrations to Protein D (Anti-PD) | Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | LU/mL | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
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| Secondary | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
|
Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 0 | 51 | 5 | 51 | 47 | 51 |
| EG001 | GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 0 | 52 | 3 | 52 | 49 | 52 |
| EG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 0 | 52 | 5 | 52 | 49 | 52 |
| EG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 0 | 51 | 0 | 51 | 49 | 51 |
| EG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). | 0 | 51 | 4 | 51 | 49 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngo-tonsillitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Redness Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Swelling Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Redness Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Swelling Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drowsiness Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Irritability Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Loss of appetite Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Temperature/Rectally Primary | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drowsiness Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Irritability Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Loss of appetite Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Temperature/Rectally Booster | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis Primary | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis Booster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis Primary | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis Booster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Varicella | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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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 |
|---|---|
| D013290 | Streptococcal Infections |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
Not provided
Not provided
| Male |
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| White-Arabic/North African heritage |
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| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
|
|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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| OG002 |
| Synflorix/GSK 2189242A-LD Group |
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
|
|
| OG002 | Synflorix/GSK 2189242A-LD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG003 | Synflorix/GSK 2189242A-HD Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
| OG004 | Synflorix Group | Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). |
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