Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000283-23 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimenrix Group | Experimental | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| Mencevax ACWY Group | Active Comparator | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimenrix | Biological | Single dose, intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8). | One month after vaccination (Post-vaccination, study Month 1) |
| Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Grade 3 symptom was defined as symptom that prevented normal, everyday activities. | During the 4-day (Days 0-3) post-vaccination period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. | Pre vaccination (Month 0) and post vaccination (Month 1) |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Goā | 403202 | India | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21278617 | Background | Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02. |
| 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 |
|---|---|---|---|
| 109495 | 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.
Not provided
Not provided
Not provided
Not provided
A total of 1504 subjects were enrolled into the study, and 1501 of them were vaccinated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| FG001 | Mencevax ACWY Group | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG001 | Mencevax ACWY Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Count of Participants | Participants | One month after vaccination (Post-vaccination, study Month 1) |
|
Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
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 | Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (< 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mencevax | Biological | Single dose, subcutaneous injection |
|
Antibody titers were expressed as geometric mean titers (GMTs). |
| Pre vaccination (Month 0) and post vaccination (Month 1) |
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively. | Pre vaccination (Month 0) and post vaccination (Month 1) |
| Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) | Pre vaccination (Month 0) and post vaccination (Month 1) |
| Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | Pre vaccination (Month 0) and post vaccination, (Month 1) |
| Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | Pre vaccination (Month 0) and post vaccination (Month 1) |
| Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after vaccination |
| Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after vaccination |
| Number of Subjects < 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | During the 4-day (Days 0-3) follow-up period after vaccination |
| Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | During the 4-day (Days 0-3) follow-up period after vaccination |
| Number of Subjects Reporting Specific Adverse Events (AEs) | Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits. | From Day 0 up to 6 months after vaccination |
| Number of Subjects Reporting Any Unsolicited Symptoms | Unsolicited symptom covers any symptom 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. | Up to one month (Day 0-Day 30) after vaccination |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 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 up to 6 months after vaccination |
| Indore |
| 452001 |
| India |
| GSK Investigational Site | New Delhi | 110002 | India |
| GSK Investigational Site | Vellore | 632004 | India |
| GSK Investigational Site | Beirut | 1107-2020 | Lebanon |
| GSK Investigational Site | Sampaloc, Manila | 1008 | Philippines |
| GSK Investigational Site | Riyadh | Saudi Arabia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109495 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109495 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109495 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109495 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109495 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109495 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Mencevax ACWY Group | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
|
|
|
| Primary | Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Grade 3 symptom was defined as symptom that prevented normal, everyday activities. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Count of Participants | Participants | Pre vaccination (Month 0) and post vaccination (Month 1) |
|
|
|
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were expressed as geometric mean titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Pre vaccination (Month 0) and post vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Count of Participants | Participants | Pre vaccination (Month 0) and post vaccination (Month 1) |
|
|
|
| Secondary | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Pre vaccination (Month 0) and post vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Count of Participants | Participants | Pre vaccination (Month 0) and post vaccination, (Month 1) |
|
|
|
| Secondary | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Pre vaccination (Month 0) and post vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Specific Adverse Events (AEs) | Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 6 months after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any Unsolicited Symptoms | Unsolicited symptom covers any symptom 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Up to one month (Day 0-Day 30) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 6 months after vaccination |
|
|
|
| 0 |
| 1,125 |
| 15 |
| 1,125 |
| 416 |
| 1,125 |
| EG001 | Mencevax ACWY Group | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. | 0 | 376 | 7 | 376 | 155 | 376 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperchlorhydria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Amoebic dysentery | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Parasitic gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
|
| Redness (< 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age. |
|
| Swelling (< 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age. |
|
| Pain (≥ 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
| Redness (≥ 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
| Swelling (≥ 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
| Drowsiness | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age. |
|
| Fever (Orally) (< 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age. |
|
| Irritability | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age. |
|
| Loss of appetite | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects < 6 years of age. |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
| Fever (Orally) (≥ 6 years of age) | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
| Gastrointestinal | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
| Headache | General disorders | MedDRA 12.0 | Systematic Assessment | Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age. |
|
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.
| D007239 | Infections |
| rSBA-MenA≥ 1:8, M1 |
|
|
| rSBA-MenA ≥ 1:128, M0 |
|
|
| rSBA-MenA≥ 1:128, M1 |
|
|
| rSBA-MenC≥ 1:8, M0 |
|
|
| rSBA-MenC≥ 1:8, M1 |
|
|
| rSBA-MenC ≥ 1:128 M0 |
|
|
| rSBA-MenC ≥ 1:128 M1 |
|
|
| rSBA-MenW-135 ≥ 1:8, M0 |
|
|
| rSBA-MenW-135 ≥ 1:8, M1 |
|
|
| rSBA-MenW-135. ≥ 1:128 M0 |
|
|
| rSBA-MenW-135 ≥ 1:128 M1 |
|
|
| rSBA-MenY ≥ 1:8, M0 |
|
|
| rSBA-MenY ≥ 1:8, M1 |
|
|
| rSBA-MenY≥ 1:128 M0 |
|
|
| rSBA-MenY ≥ 1:128 M1 |
|
|
| rSBA-MenA, M1 |
|
|
| rSBA-MenC, M0 |
|
|
| rSBA-MenC, M1 |
|
|
| rSBA-MenW-135, M0 |
|
|
| rSBA-MenW-135, M1 |
|
|
| rSBA-MenY, M0 |
|
|
| rSBA-MenY, M1 |
|
|
| Anti-TT ≥ 0.1 IU/mL, M1 |
|
|
| Anti-TT ≥ 1.0 IU/mL, M0 |
|
|
| Anti-TT ≥1.0 IU/mL, M1 |
|
|
| Anti-TT, M1 |
|
|
| Anti-PSA ≥ 0.3 μg/mL, M1 |
|
|
| Anti-PSA ≥ 2.0 μg/mL, M0 |
|
|
| Anti-PSA ≥ 2.0 μg/mL, M1 |
|
|
| Anti-PSC ≥ 0.3 μg/mL, M0 |
|
|
| Anti-PSC ≥ 0.3 μg/mL, M1 |
|
|
| Anti-PSC ≥ 2.0 μg/mL, M0 |
|
|
| Anti-PSC ≥ 2.0 μg/mL M1 |
|
|
| Anti-PSW-135 ≥ 0.3 μg/mL, M0 |
|
|
| Anti-PSW-135 ≥ 0.3 μg/mL, M1 |
|
|
| Anti-PSW-135 ≥ 2.0 μg/mL M0 |
|
|
| Anti-PSW-135 ≥ 2.0 μg/mL M1 |
|
|
| Anti-PSY ≥ 0.3 μg/mL, M0 |
|
|
| Anti-PSY ≥ 0.3 μg/mL, M1 |
|
|
| Anti-PSY ≥ 2.0 μg/mL, M0 |
|
|
| Anti-PSY ≥ 2.0 μg/mL, M1 |
|
|
| Anti-PSA, M1 |
|
|
| Anti-PSC, M0 |
|
|
| Anti-PSC, M1 |
|
|
| Anti-PSW-135, M0 |
|
|
| Anti-PSW-135, M1 |
|
|
| Anti-PSY, M0 |
|
|
| Anti-PSY, M1 |
|
|
| Any Swelling |
|
| Any Swelling |
|
| Any Irritability |
|
| Any Loss of apptite |
|
| Any Gastrointestinal |
|
| Any Headache |
|
| ER visit (s) |
|