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In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.
These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups.
This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mencevax Primed Group | Experimental | Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
|
| Mencevax Naive Group | Active Comparator | Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine GSK134612 (Nimenrix) | Biological | one dose, as intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs). | One month post-vaccination (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal rSBA Titers | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs). | Prior to vaccination (Day 0) |
| Anti-meningococcal Polysaccharide (PS) Antibody Concentrations |
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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 |
|---|---|---|---|
| 22704725 | Background | Dbaibo G, Van der Wielen M, Reda M, Medlej F, Tabet C, Boutriau D, Sumbul A, Anis S, Miller JM. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine. Int J Infect Dis. 2012 Aug;16(8):e608-15. doi: 10.1016/j.ijid.2012.04.006. Epub 2012 Jun 14. | |
| Background | Dbaibo G et al. One dose of the meningococcal tetravalent tetanus toxoid conjugated vaccine (MenACWY-TT) is immunogenic with an acceptable safety profile in unvaccinated subjects and those previously vaccinated with a MenACWY polysaccharide vaccine. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010. |
| 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 |
|---|---|---|---|
| 107408 | Informed Consent Form | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Mencevax Primed Group | Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| FG001 | Mencevax Naive Group | Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mencevax Primed Group | Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| BG001 |
| 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 | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month post-vaccination (Month 1) |
|
Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
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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 | Mencevax Primed Group | Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| 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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For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs). |
| Prior to (Day 0) and one month post-vaccination (Month 1) |
| Anti-tetanus Toxoid Antibody Concentrations | Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs). | Prior to (Day 0) and one month post-vaccination (Month 1) |
| Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | Vaccine response defined as: For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer | One month post-vaccination (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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | During the 4-day (Day 0 to Day 3) period after vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Day 0 to Day 3) period after vaccination |
| Number of Subjects With Unsolicited Symptoms | An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination. | Up to one month post-vaccination (Month 1) |
| Number of Subjects Reporting Any Serious Adverse Events | 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. | Day 0 to study month 6 |
| Number of Subjects With Any Specific Adverse Events | Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease). Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately. | Day 0 to study month 6 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107408 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107408 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107408 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107408 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107408 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107408 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Mencevax Naive Group |
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Mencevax Naive Group | Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
|
|
| Secondary | Meningococcal rSBA Titers | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to vaccination (Day 0) |
|
|
|
| Secondary | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Prior to (Day 0) and one month post-vaccination (Month 1) |
|
|
|
| Secondary | Anti-tetanus Toxoid Antibody Concentrations | Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Prior to (Day 0) and one month post-vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | Vaccine response defined as: For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available. | Posted | Count of Participants | Participants | One month post-vaccination (Month 1) |
|
|
|
| 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 100 millimeters (mm) of injection site. | This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included. | Posted | Count of Participants | Participants | During the 4-day (Day 0 to Day 3) period after vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included. | Posted | Count of Participants | Participants | During the 4-day (Day 0 to Day 3) period after vaccination |
|
|
|
| Secondary | Number of Subjects With Unsolicited Symptoms | An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination. | This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Up to one month post-vaccination (Month 1) |
|
|
|
| Secondary | Number of Subjects Reporting Any Serious Adverse Events | 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. | This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Day 0 to study month 6 |
|
|
|
| Secondary | Number of Subjects With Any Specific Adverse Events | Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease). Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately. | This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Day 0 to study month 6 |
|
|
|
| 0 |
| 192 |
| 1 |
| 192 |
| 111 |
| 192 |
| EG001 | Mencevax Naive Group | Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. | 0 | 79 | 0 | 79 | 42 | 79 |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | 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-MenC |
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| rSBA-MenW-135 |
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| rSBA-MenY |
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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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| rSBA-MenC |
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| rSBA-MenW-135 |
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| rSBA-MenY |
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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 Fever (oral temperature) |
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| Grade 3 Fever (oral temperature) |
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| Related Fever (oral temperature) |
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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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| Subjects with any ER visit(s) |
|