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This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine GSK 134612 | Biological | Intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY) | Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination. | One month after vaccination (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. | At Day 0 and Month 1 |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value |
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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 | Beirut | 1107-2020 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23494214 | Background | Dbaibo G, El-Ayoubi N, Ghanem S, Hajar F, Bianco V, Miller JM, Mesaros N. Immunogenicity and safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered to adults aged 56 Years and older: results of an open-label, randomized, controlled trial. Drugs Aging. 2013 May;30(5):309-19. doi: 10.1007/s40266-013-0065-0. |
| 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 |
|---|---|---|---|
| 113807 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Out of the total number of subjects originally enrolled, only 369 subjects were eventually found to be eligible to be included in the Total Vaccinated Cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nimenrix Group | Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0. |
| FG001 | Mencevax Group | Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nimenrix Group | Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0. |
| BG001 | Mencevax Group |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY) | Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination. | The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | Count of Participants | Participants | One month after vaccination (Month 1) |
|
Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (from Day 0 up to Month 1).
All frequent adverse events reported were below the 5% frequency threshold.
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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 | Nimenrix Group | Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| 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 |
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| MencevaxACWY TM |
| Biological |
Subcutaneous injection |
|
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. |
| At Day 0 and Month 1 |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | At Day 0 and Month 1 |
| Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL). | At Day 0 and Month 1 |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL). | At Day 0 and Month 1 |
| Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL). | At Day 0 and Month 1 |
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | At Day 0 and Month 1 |
| Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | At Day 0 and Month 1 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | Within 4 days (Day 0 to 3) post-vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. | Within 4 days (Day 0 to 3) post-vaccination |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | Within 31 days (Day 0 to 30) after vaccination |
| Number of Subjects With 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. | Within 31 days (Day 0 to 30) after vaccination |
| Number of Subjects With New Onset Chronic Illnesses (NOCI) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | Within 31 days (Day 0 to 30) after vaccination |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113807 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113807 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113807 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113807 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113807 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Migrated/moved from study area |
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| Lost to Follow-up |
|
Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| Nimenrix Group |
Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0. |
| OG001 | Mencevax Group | Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0. |
|
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. | The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | Count of Participants | Participants | At Day 0 and Month 1 |
|
|
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| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. | The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | Count of Participants | Participants | At Day 0 and Month 1 |
|
|
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| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 and Month 1 |
|
|
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| Secondary | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL). | The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY. | Posted | Count of Participants | Participants | At Day 0 and Month 1 |
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| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL). | The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY. | Posted | Count of Participants | Participants | At Day 0 and Month 1 |
|
|
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| Secondary | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL). | The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Day 0 and Month 1 |
|
|
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| Secondary | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | Count of Participants | Participants | At Day 0 and Month 1 |
|
|
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| Secondary | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Day 0 and Month 1 |
|
|
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets. | Posted | Count of Participants | Participants | Within 4 days (Day 0 to 3) post-vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. | The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets. | Posted | Count of Participants | Participants | Within 4 days (Day 0 to 3) post-vaccination |
|
|
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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 primary analysis was performed on the Total Vaccinated cohort (TVC), which cohort included all subjects with vaccine administration documented. | Posted | Count of Participants | Participants | Within 31 days (Day 0 to 30) after vaccination |
|
|
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| Secondary | Number of Subjects With 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 primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented. | Posted | Count of Participants | Participants | Within 31 days (Day 0 to 30) after vaccination |
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| Secondary | Number of Subjects With New Onset Chronic Illnesses (NOCI) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented. | Posted | Count of Participants | Participants | Within 31 days (Day 0 to 30) after vaccination |
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| 0 |
| 274 |
| 0 |
| 274 |
| 0 |
| 274 |
| EG001 | Mencevax Group | Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0. | 0 | 95 | 1 | 95 | 0 | 95 |
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 1 |
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| rSBA-MenC, Day 0 |
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| rSBA-MenC, Month 1 |
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| rSBA-MenW-135, Day 0 |
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| rSBA-MenW-135, Month 1 |
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| rSBA-MenY, Day 0 |
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| rSBA-MenY, Month 1 |
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| rSBA-MenA, Month 1 |
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| rSBA-MenC, Day 0 |
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| rSBA-MenC, Month 1 |
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| rSBA-MenW-135, Day 0 |
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| rSBA-MenW-135, Month 1 |
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| rSBA-MenY, PRE Day 0 |
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| rSBA-MenY, Month 1 |
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| rSBA-MenA, Month 1 |
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| rSBA-MenC, Day 0 |
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| rSBA-MenC, Month 1 |
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| rSBA-MenW-135, Day 0 |
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| rSBA-MenW-135, Month 1 |
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| rSBA-MenY, Day 0 |
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| rSBA-MenY, Month 1 |
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| anti-PSA, Month 1 |
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| anti-PSC, Day 0 |
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| anti-PSC, Month 1 |
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| anti-PSW-135, Day 0 |
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| anti-PSW-135, Month 1 |
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| anti-PSY, Day 0 |
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| anti-PSY, Month 1 |
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| anti-PSA, Month 1 |
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| anti-PSC, Day 0 |
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| anti-PSC, Month 1 |
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| anti-PSW-135, Day 0 |
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| anti-PSW-135, Month 1 |
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| anti-PSY, Day 0 |
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| anti-PSY, Month 1 |
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| anti-PSA, Month 1 |
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| anti-PSC, Day 0 |
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| anti-PSC, Month 1 |
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| anti-PSW-135, Day 0 |
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| anti-PSW-135, Month 1 |
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| anti-PSY, Day 0 |
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| anti-PSY, Month 1 |
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| Any Redness |
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| Grade 3 Redness |
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| Any Swelling |
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| Grade 3 Swelling |
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| Related Fatigue |
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| Any Gastrointestinal symptoms |
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| Grade 3 Gastrointestinal symptoms |
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| Related Gastrointestinal symptoms |
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| Any Headache |
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| Grade 3 Headache |
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| Related Headache |
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| Any Temperature (Orally) |
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| Grade 3 Temperature (Orally) |
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| Related Temperature (Orally) |
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