| ID | Type | Description | Link |
|---|---|---|---|
| 107392 (Ext: Y1) | Other Identifier | GSK | |
| 107398 (Ext: Y2) | Other Identifier | GSK | |
| 107402 (Ext: Y3) | Other Identifier | GSK | |
| 107404 (Ext: Y4) | Other Identifier | GSK | |
| 107406 (Ext: Y5) | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives & outcome measures of both the primary & extension phases.
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimenrix Group | Experimental | Subjects receiving GSK Biologicals' meningococcal vaccine 134612 |
|
| Mencevax Group | Active Comparator | Subjects receiving Mencevax™ ACWY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meningococcal ACWY (vaccine) | Biological | One intramuscular dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination. | One month post vaccination |
| Occurrence of Any Grade 3 Systemic Symptoms | Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C. | During the 4-day (Days 0-3) post-vaccination period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (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 and (≥) 1:128. | Prior to and 1 Month after vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Specific criteria to be checked at each study visit for the long term follow-up:
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 | City of Muntinlupa | 1781 | Philippines | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26437712 | Derived | Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y. | |
| 23510357 |
| 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 |
|---|---|---|---|
| 107386 | 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.
Not provided
Not provided
Not provided
Not provided
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nimenrix Group | Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region. |
| FG001 | Mencevax Group | Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Phase |
|
| ||||||||||||||||||
| Year 1 |
| |||||||||||||||||||
| Year 2 |
| |||||||||||||||||||
| Year 3 |
| |||||||||||||||||||
| Year 4 |
| |||||||||||||||||||
| Year 5 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nimenrix Group | Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region. |
| BG001 | Mencevax Group | Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm. |
| 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 | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Number | 95% Confidence Interval | Percentage of subjects | One month post vaccination |
|
Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months 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 who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Pain | General disorders | MedDRA 15.1 | Systematic Assessment | This solicited local symptom was only collected from subjects with their symptom sheets completed. |
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
| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mencevax™ ACWY |
| Biological |
One subcutaneous dose. |
|
| rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | Prior to and 1 Month after vaccination |
| Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. | Prior to and 1 Month after vaccination |
| Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL). | Prior to and 1 Month after vaccination |
| Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | Prior to and 1 Month after vaccination |
| Concentration of Anti-TT Antibodies | Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). | Prior to and 1 Month after vaccination |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128. | At Year 1 |
| rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | At Year 1 |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | At Year 2 |
| rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | At Year 2 |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | At Year 3 |
| rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | At Year 3 |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | At Year 4 |
| rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | At Year 4 |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | At Year 5 |
| rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | At Year 5 |
| Number of Subjects With Anti-PS Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL. | At Year 1 |
| Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL. | At Year 1 |
| Number of Subjects With Anti-PS Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL. | At Year 2 |
| Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL. | At Year 2 |
| Number of Subjects With Anti-PS Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. | At Year 3 |
| Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL. | At Year 3 |
| 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 = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From Day 0 up to 6 Months after vaccination |
| Number of Subjects With Rash | From Day 0 up to 6 Months after vaccination |
| Number of Subjects With AEs Resulting in Emergency Rooms Visits | From Day 0 up to 6 Months after vaccination |
| Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | Up to 31 Days after vaccination |
| 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. | From Day 0 up to 6 Months after vaccination |
| Number of Subjects With SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | At Year 1, Year 2, Year 3, Year 4 and Year 5 |
| Manila |
| 1000 |
| Philippines |
| GSK Investigational Site | Riyadh | Saudi Arabia |
| Derived |
| Borja-Tabora C, Montalban C, Memish ZA, Van der Wielen M, Bianco V, Boutriau D, Miller J. Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study. BMC Infect Dis. 2013 Mar 5;13:116. doi: 10.1186/1471-2334-13-116. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107386 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107386 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107386 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107386 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107386 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Mencevax Group | Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm. |
|
|
|
| Primary | Occurrence of Any Grade 3 Systemic Symptoms | Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
|
| Secondary | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (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 and (≥) 1:128. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from whom immunogenicity data were available. | Posted | Count of Participants | Participants | Prior to and 1 Month after vaccination |
|
|
|
| Secondary | rSBA Antibody Titers | 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 immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to and 1 Month after vaccination |
|
|
|
| Secondary | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | The cut-off value for the anti-PS concentration was 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 immunogenicity data were available. | Posted | Count of Participants | Participants | Prior to and 1 Month after vaccination |
|
|
|
| Secondary | Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Prior to and 1 Month after vaccination |
|
|
|
| Secondary | Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Cut-off values assessed were greater than or equal to (≥) 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 immunogenicity data were available. | Posted | Count of Participants | Participants | Prior to and 1 Month after vaccination |
|
|
|
| Secondary | Concentration of Anti-TT Antibodies | Concentrations are presented as geometric mean concentrations (GMCs) 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 immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Prior to and 1 Month after vaccination |
|
|
|
| Secondary | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point. | Posted | Count of Participants | Participants | At Year 1 |
|
|
|
| Secondary | rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Year 1 |
|
|
|
| Secondary | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point. | Posted | Count of Participants | Participants | At Year 2 |
|
|
|
| Secondary | rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point. | Posted | Geometric Mean | 95% Confidence Interval | Titre | At Year 2 |
|
|
|
| Secondary | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point. | Posted | Count of Participants | Participants | At Year 3 |
|
|
|
| Secondary | rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Year 3 |
|
|
|
| Secondary | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point. | Posted | Count of Participants | Participants | At Year 4 |
|
|
|
| Secondary | rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Year 4 |
|
|
|
| Secondary | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point. | Posted | Count of Participants | Participants | At Year 5 |
|
|
|
| Secondary | rSBA Antibody Titers | Antibody titers are presented as Geometric Mean Titers (GMTs). | The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Year 5 |
|
|
|
| Secondary | Number of Subjects With Anti-PS Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL. | The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point. | Posted | Count of Participants | Participants | At Year 1 |
|
|
|
| Secondary | Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL. | The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Year 1 |
|
|
|
| Secondary | Number of Subjects With Anti-PS Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL. | The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point. | Posted | Count of Participants | Participants | At Year 2 |
|
|
|
| Secondary | Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL. | The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Year 2 |
|
|
|
| Secondary | Number of Subjects With Anti-PS Antibodies | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. | The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point. | Posted | Count of Participants | Participants | At Year 3 |
|
|
|
| Secondary | Concentration of Anti-PS Antibodies | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL. | The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Year 3 |
|
|
|
| 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 = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available and who had the symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 6 Months after vaccination |
|
|
|
| Secondary | Number of Subjects With Rash | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 6 Months after vaccination |
|
|
|
| Secondary | Number of Subjects With AEs Resulting in Emergency Rooms Visits | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 6 Months after vaccination |
|
|
|
| Secondary | Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | Up to 31 Days after vaccination |
|
|
|
| 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 vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to 6 Months after vaccination |
|
|
|
| Secondary | Number of Subjects With 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 vaccinated subjects from whom data were available. | Posted | Count of Participants | Participants | At Year 1, Year 2, Year 3, Year 4 and Year 5 |
|
|
|
| 0 |
| 374 |
| 1 |
| 374 |
| 186 |
| 374 |
| EG001 | Mencevax Group | Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm. | 0 | 126 | 0 | 126 | 53 | 126 |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
|
| Any Redness | General disorders | MedDRA 15.1 | Systematic Assessment | This solicited local symptom was only collected from subjects with their symptom sheets completed. |
|
| Any Swelling | General disorders | MedDRA 15.1 | Systematic Assessment | This solicited local symptom was only collected from subjects with their symptom sheets completed. |
|
| Any Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment | This solicited general symptom was only collected from subjects with their symptom sheets completed. |
|
| Any Headache | General disorders | MedDRA 15.1 | Systematic Assessment | This solicited general symptom was only collected from subjects with their symptom sheets completed. |
|
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 |
| Grade 3 solicited local |
|
| rSBA-MenA (PI [M1]) ≥ 1:8 |
|
|
| rSBA-MenA (PRE) ≥ 1:128 |
|
|
| rSBA-MenA (PI [M1]) ≥ 1:128 |
|
|
| rSBA-MenC (PRE) ≥ 1:8 |
|
|
| rSBA-MenC (PI [M1]) ≥ 1:8 |
|
|
| rSBA-MenC (PRE) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M1]) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PRE) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PI [M1]) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PRE) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PI [M1]) ≥ 1:128 |
|
|
| rSBA-MenY (PRE) ≥ 1:8 |
|
|
| rSBA-MenY (PI [M1]) ≥ 1:8 |
|
|
| rSBA-MenY (PRE) ≥ 1:128 |
|
|
| rSBA-MenY (PI [M1]) ≥ 1:128 |
|
|
| rSBA-MenA (PI [M1]) |
|
|
| rSBA-MenC (PRE) |
|
|
| rSBA-MenC (PI [M1]) |
|
|
| rSBA-MenW-135 (PRE) |
|
|
| rSBA-MenW-135 (PI [M1]) |
|
|
| rSBA-MenY (PRE) |
|
|
| rSBA-MenY (PI [M1]) |
|
|
| Anti-PSA (PI [M1]) ≥ 0.3 μg/mL |
|
|
| Anti-PSA (PRE) ≥ 2.0 μg/mL |
|
|
| Anti-PSA (PI [M1]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PRE) ≥ 0.3 μg/mL |
|
|
| Anti-PSC (PI [M1]) ≥ 0.3 μg/mL |
|
|
| Anti-PSC (PRE) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M1]) ≥ 2.0 μg/mL |
|
|
| Anti-PSW-135 (PRE) ≥ 0.3 μg/mL |
|
|
| Anti-PSW-135 (PI [M1]) ≥ 0.3 μg/mL |
|
|
| Anti-PSW-135 (PRE) ≥ 2.0 μg/mL |
|
|
| Anti-PSW-135 (PI [M1]) ≥ 2.0 μg/mL |
|
|
| Anti-PSY (PRE) ≥ 0.3 μg/mL |
|
|
| Anti-PSY (PI [M1]) ≥ 0.3 μg/mL |
|
|
| Anti-PSY (PRE) ≥ 2.0 μg/mL |
|
|
| Anti-PSY (PI [M1]) ≥ 2.0 μg/mL |
|
|
| Anti-PSA (PI [M1]) |
|
|
| Anti-PSC (PRE) |
|
|
| Anti-PSC (PI [M1]) |
|
|
| Anti-PSW-135 (PRE) |
|
|
| Anti-PSW-135 (PI [M1]) |
|
|
| Anti-PSY (PRE) |
|
|
| Anti-PSY (PI [M1]) |
|
|
| Anti-TT (PI [M1]) |
|
|
| Anti-TT (PI [M1]) |
|
|
| rSBA-MenA (PI [M12]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M12]) ≥ 1:8 |
|
|
| rSBA-MenC (PI [M12]) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PI [M12]) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PI [M12]) ≥ 1:128 |
|
|
| rSBA-MenY (PI [M12]) ≥ 1:8 |
|
|
| rSBA-MenY (PI [M12]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M12]) |
|
|
| rSBA-MenW-135 (PI [M12]) |
|
|
| rSBA-MenY (PI [M12]) |
|
|
| rSBA-MenA (PI [M24]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M24]) ≥ 1:8 |
|
|
| rSBA-MenC (PI [M24]) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PI [M24]) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PI [M24]) ≥ 1:128 |
|
|
| rSBA-MenY (PI [M24]) ≥ 1:8 |
|
|
| rSBA-MenY (PI [M24]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M24]) |
|
|
| rSBA-MenW-135 (PI [M24]) |
|
|
| rSBA-MenY (PI [M24]) |
|
|
| rSBA-MenA (PI [M36]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M36]) ≥ 1:8 |
|
|
| rSBA-MenC (PI [M36]) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PI [M36]) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PI [M36]) ≥ 1:128 |
|
|
| rSBA-MenY (PI [M36]) ≥ 1:8 |
|
|
| rSBA-MenY (PI [M36]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M36]) |
|
|
| rSBA-MenW-135 (PI [M36]) |
|
|
| rSBA-MenY (PI [M36]) |
|
|
| rSBA-MenA (PI [M48]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M48]) ≥ 1:8 |
|
|
| rSBA-MenC (PI [M48]) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PI [M48]) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PI [M48]) ≥ 1:128 |
|
|
| rSBA-MenY (PI [M48]) ≥ 1:8 |
|
|
| rSBA-MenY (PI [M48]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M48]) |
|
|
| rSBA-MenW-135 (PI [M48]) |
|
|
| rSBA-MenY (PI [M48]) |
|
|
| rSBA-MenA (PI [M60]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M60]) ≥ 1:8 |
|
|
| rSBA-MenC (PI [M60]) ≥ 1:128 |
|
|
| rSBA-MenW-135 (PI [M60]) ≥ 1:8 |
|
|
| rSBA-MenW-135 (PI [M60]) ≥ 1:128 |
|
|
| rSBA-MenY (PI [M60]) ≥ 1:8 |
|
|
| rSBA-MenY (PI [M60]) ≥ 1:128 |
|
|
| rSBA-MenC (PI [M60]) |
|
|
| rSBA-MenW-135 (PI [M60]) |
|
|
| rSBA-MenY (PI [M60]) |
|
|
| Anti-PSA (PI [M12]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M12]) ≥ 0.3 μg/mL |
|
|
| Anti-PSC (PI [M12]) ≥ 2.0 μg/mL |
|
|
| Anti-PSW-135 (PI [M12]) ≥ 0.3 μg/mL |
|
|
| Anti-PSW-135 (PI [M12]) ≥ 2.0 μg/mL |
|
|
| Anti-PSY (PI [M12]) ≥ 0.3 μg/mL |
|
|
| Anti-PSY (PI [M12]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M12]) |
|
|
| Anti-PSW-135 (PI [M12]) |
|
|
| Anti-PSY (PI [M12]) |
|
|
| Anti-PSA (PI [M24]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M24]) ≥ 0.3 μg/mL |
|
|
| Anti-PSC (PI [M24]) ≥ 2.0 μg/mL |
|
|
| Anti-PSW-135 (PI [M24]) ≥ 0.3 μg/mL |
|
|
| Anti-PSW-135 (PI [M24]) ≥ 2.0 μg/mL |
|
|
| Anti-PSY (PI [M24]) ≥ 0.3 μg/mL |
|
|
| Anti-PSY (PI [M24]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M24]) |
|
|
| Anti-PSW-135 (PI [M24]) |
|
|
| Anti-PSY (PI [M24]) |
|
|
| Anti-PSA (PI [M36]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M36]) ≥ 0.3 μg/mL |
|
|
| Anti-PSC (PI [M36]) ≥ 2.0 μg/mL |
|
|
| Anti-PSW-135 (PI [M36]) ≥ 0.3 μg/mL |
|
|
| Anti-PSW-135 (PI [M36]) ≥ 2.0 μg/mL |
|
|
| Anti-PSY (PI [M36]) ≥ 0.3 μg/mL |
|
|
| Anti-PSY (PI [M36]) ≥ 2.0 μg/mL |
|
|
| Anti-PSC (PI [M36]) |
|
|
| Anti-PSW-135 (PI [M36]) |
|
|
| Anti-PSY (PI [M36]) |
|
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Related Fatigue |
|
| ≥ 37.5 ˚C Fever |
|
| >39.5 ˚C Fever |
|
| Related Fever |
|
| Any Gastrointestinal |
|
| Grade 3 Gastrointestinal |
|
| Related Gastrointestinal |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any (SAE)s Year 3 |
|
| Any (SAE)s Year 4 |
|
| Any (SAE)s Year 5 |
|