Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects of 11-17 years of age who will receive GSK134612 |
|
| Group B | Active Comparator | Subjects of 11-17 years of age who will receive MencevaxTM ACWY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine GSK134612 | Biological | One intramuscular dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Vaccine Response to Meningococcal Antigens | Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8]. | One month post-vaccination (At Month 1) |
| Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms | General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C). | During the 4-day (Days 0-3) period after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | Prior to (Month 0) and one month after vaccination (Month 1) |
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 |
|---|---|---|---|
| 21343698 | Derived | Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 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 |
|---|---|---|---|
| 109069 | Statistical Analysis Plan | 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
The target sample size was 1024 enrolled subjects, but a total of 1025 subjects (in all age strata) were actually enrolled and vaccinated in seven study centres in India, Taiwan and the Philippines.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nimenrix Group | Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm. |
| FG001 | Mencevax ACWY Group | Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nimenrix Group | Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, 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 Meningococcal Antigens | Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8]. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Count of Participants | Participants | One month post-vaccination (At Month 1) |
|
Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
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 | Nimenrix Group | Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix™ (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| 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™ ACWY |
| Biological |
One subcutaneous dose |
|
| Meningococcal rSBA Antibody Titers | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs). | Prior to (Month 0) and one month after vaccination (Month 1) |
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL). | Prior to (Month 0) and one month after vaccination (Month 1) |
| Anti-TT Antibody Concentrations | Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | Prior to (Month 0) and one month after vaccination (Month 1) |
| Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. | Prior to (Month 0) and one month after vaccination (Month 1) |
| Anti-meningococcal Polysaccharide Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). | Prior to (Month 0) and one month after vaccination (Month 1) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm). | During the 4-day (Days 0-3) period after vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination. | During the 4-day (Days 0-3) period after vaccination |
| Number of Subjects With Any Unsolicited Adverse Events | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects With Any Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Up to study end (Month 6) |
| Number of Subjects With Specific Adverse Events | These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease). | Up to study end (Month 6) |
| Indore |
| 452001 |
| India |
| GSK Investigational Site | New Delhi | 110002 | India |
| GSK Investigational Site | Pune | 411 011 | India |
| GSK Investigational Site | City of Muntinlupa | 1781 | Philippines |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Tao Yuan County | 333 | Taiwan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109069 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109069 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109069 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109069 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109069 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109069 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
| OG001 | Mencevax ACWY Group | Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm. |
|
|
|
| Primary | Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms | General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) period after vaccination |
|
|
|
|
| Secondary | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Count of Participants | Participants | Prior to (Month 0) and one month after vaccination (Month 1) |
|
|
|
| Secondary | Meningococcal rSBA Antibody Titers | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented 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 data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) and one month after vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Count of Participants | Participants | Prior to (Month 0) and one month after vaccination (Month 1) |
|
|
|
| Secondary | Anti-TT Antibody Concentrations | Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Prior to (Month 0) and one month after vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Count of Participants | Participants | Prior to (Month 0) and one month after vaccination (Month 1) |
|
|
|
| Secondary | Anti-meningococcal Polysaccharide Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Prior to (Month 0) and one month after vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) period after vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) period after vaccination |
|
|
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | Serious adverse events (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 vaccinated subjects. | Posted | Count of Participants | Participants | Up to study end (Month 6) |
|
|
|
| Secondary | Number of Subjects With Specific Adverse Events | These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Up to study end (Month 6) |
|
|
|
| 0 |
| 768 |
| 3 |
| 768 |
| 311 |
| 768 |
| EG001 | Mencevax ACWY Group | Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax™ ACWY vaccine, administered subcutaneously into the non-dominant upper arm. | 0 | 257 | 2 | 257 | 99 | 257 |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Amoebic dysentery | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Redness | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | General disorders | MedDRA 12.0 | 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.
| D007239 | Infections |
| rSBA-MenA, Month 0 ≥ 1:128 |
|
|
| rSBA-MenA, Month 1 ≥ 1:8 |
|
|
| rSBA-MenA, Month 1 ≥ 1:128 |
|
|
| rSBA-MenC, Month 0 ≥ 1:8 |
|
|
| rSBA-MenC, Month 0 ≥ 1:128 |
|
|
| rSBA-MenC, Month 1 ≥ 1:8 |
|
|
| rSBA-MenC, Month 1 ≥ 1:128 |
|
|
| rSBA- MenW-135, Month 0 ≥ 1:8 |
|
|
| rSBA- MenW-135, Month 0 ≥ 1:128 |
|
|
| rSBA- MenW-135, Month 1 ≥ 1:8 |
|
|
| rSBA- MenW-135, Month 1 ≥ 1:128 |
|
|
| rSBA-MenY, Month 0 ≥ 1:8 |
|
|
| rSBA-MenY, Month 0 ≥ 1:128 |
|
|
| rSBA-MenY, Month 1 ≥ 1:8 |
|
|
| rSBA-MenY, Month 1 ≥ 1:128 |
|
|
| rSBA-MenA, Month 1 |
|
|
| rSBA-MenC, Month 0 |
|
|
| rSBA-MenC, Month 1 |
|
|
| rSBA- MenW-135, Month 0 |
|
|
| rSBA- MenW-135, Month 1 |
|
|
| rSBA-MenY, Month 0 |
|
|
| rSBA-MenY, Month 1 |
|
|
| Anti-PSA ≥ 0.3 ug/mL, Month 1 |
|
|
| Anti-PSC ≥ 0.3 ug/mL, Month 0 |
|
|
| Anti-PSC ≥ 0.3 ug/mL, Month 1 |
|
|
| Anti-PSW-135 ≥ 0.3 ug/mL, Month 0 |
|
|
| Anti-PSW-135 ≥ 0.3 ug/mL, Month 1 |
|
|
| Anti-PSY ≥ 0.3 ug/mL, Month 0 |
|
|
| Anti-PSY ≥ 0.3 ug/mL, Month 1 |
|
|
| Anti-PSA ≥ 2 ug/mL, Month 0 |
|
|
| Anti-PSA ≥ 2 ug/mL, Month 1 |
|
|
| Anti-PSC ≥ 2 ug/mL, Month 0 |
|
|
| Anti-PSC ≥ 2 ug/mL, Month 1 |
|
|
| Anti-PSW-135 ≥ 2 ug/mL, Month 0 |
|
|
| Anti-PSW-135 ≥ 2 ug/mL, Month 1 |
|
|
| Anti-PSY ≥ 2 ug/mL, Month 0 |
|
|
| Anti-PSY ≥ 2 ug/mL, Month 1 |
|
|
| Anti-PSA, Month 1 |
|
|
| Anti-PSC, Month 0 |
|
|
| Anti-PSC, Month 1 |
|
|
| Anti-PSW-135, Month 0 |
|
|
| Anti-PSW-135, Month 1 |
|
|
| Anti-PSY, Month 0 |
|
|
| Anti-PSY, Month 1 |
|
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Related Fatigue |
|
| Any Fever (Axillary) |
|
| Grade 3 Fever |
|
| Related Fever |
|
| Any Gastrointestinal symptoms |
|
| Grade 3 Gastrointestinal symptoms |
|
| Related Gastrointestinal symptoms |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any ER visits |
|