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This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimenrix + Twinrix Group | Experimental | Subjects received 1 dose of Nimenrixâ„¢ vaccine at Month 0 and 1 dose of Twinrixâ„¢ vaccine at Months 0, 1 and 6. |
|
| Nimenrix Group | Active Comparator | Subjects received 1 dose of Nimenrixâ„¢ vaccine at Month 0. |
|
| Twinrix Group | Active Comparator | Subjects received 1 dose of Twinrixâ„¢ vaccine at Months 0, 1 and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimenrix (Meningococcal vaccine 134612) | Biological | Single dose intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | The rSBA titers were expressed as geometric mean titers (GMTs). | At 1 month after vaccination with Nimenrix vaccine (Month 1) |
| Number of Subjects Seroconverted for Hepatitis A | A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects. | At 1 month after the third dose of Twinrix vaccine (Month 7) |
| Number of Subjects Seroprotected for Hepatitis B | A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL). | At 1 month after the third dose of Twinrix vaccine (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8]. | At 1 month after vaccination with Nimenrix vaccine (Month 1) |
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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 | Aarhus N | 8200 | Denmark | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22107850 | Background | Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19. | |
| Background | Ostergaard L et al. The Candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugated vaccine (MenACWY-TT) co-administered with a combined hepatitis A and B vaccine (HepA/B) is immunogenic with an acceptable safety profile in subjects aged 11-17 Years. 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 |
|---|---|---|---|
| 109063 | Dataset Specification | 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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During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nimenrix + Twinrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6. |
| FG001 | Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. |
| FG002 | Twinrix Group | Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nimenrix + Twinrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6. |
| BG001 | Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. |
| 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 Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | The rSBA titers were expressed as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 1 month after vaccination with Nimenrix vaccine (Month 1) |
|
Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
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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 + Twinrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at the injection site | General disorders | Systematic Assessment | Post-meningococcal vaccination |
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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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| ID | Term |
|---|---|
| C433226 | twinrix |
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| Twinrix | Biological | 3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age. |
|
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128. | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
| Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL). | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL. | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
| Anti-Tetanus Toxoid (TT) Antibody Concentrations | Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL). | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
| Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL). | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | The rSBA titers were expressed as geometric mean titers. | At 7 months after vaccination with Nimenrix (At Month 7) |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128. | At 7 months after vaccination with Nimenrix (At Month 7) |
| Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL). | At 7 months after vaccination with Nimenrix (At Month 7) |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL. | At 7 months after vaccination with Nimenrix (At Month 7) |
| Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL). | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
| Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL). | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
| IgG Anti-HBs Antibody Concentrations | Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL). | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
| Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL). | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
| Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During a 4-day period (Days 0-3) after Nimenrix vaccination |
| Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses |
| Number of Subjects Reporting Any Solicited General Symptoms | Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group. | During a 4-day period (Days 0-3) after each vaccine dose and across doses |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Up to 1 month after each vaccine dose |
| Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses | Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies. | During the entire study (up to Month 7) |
| Number of Subjects Reporting Any Rash | Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae. | During the entire study (up to Month 7) |
| Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits | During the entire study (up to Month 7) |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study (up to Month 7) |
| Karlskrona |
| SE-371 41 |
| Sweden |
| GSK Investigational Site | Linköping | SE-581 85 | Sweden |
| GSK Investigational Site | Malmö | SE-205 02 | Sweden |
| GSK Investigational Site | Örebro | SE-701 16 | Sweden |
| GSK Investigational Site | Umeå | SE-901 85 | Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109063 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109063 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109063 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109063 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109063 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109063 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG002 | Twinrix Group | Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Nimenrix Group |
Subjects received 1 dose of Nimenrix vaccine at Month 0. |
|
|
|
| Primary | Number of Subjects Seroconverted for Hepatitis A | A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects. | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine. | Posted | Count of Participants | Participants | At 1 month after the third dose of Twinrix vaccine (Month 7) |
|
|
|
|
| Primary | Number of Subjects Seroprotected for Hepatitis B | A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine. | Posted | Count of Participants | Participants | At 1 month after the third dose of Twinrix vaccine (Month 7) |
|
|
|
|
| Secondary | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8]. | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Count of Participants | Participants | At 1 month after vaccination with Nimenrix vaccine (Month 1) |
|
|
|
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Count of Participants | Participants | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
|
|
|
| Secondary | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL). | The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies. | Posted | Geometric Mean | 95% Confidence Interval | micrograms per milliliter (µg/mL) | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
|
|
|
| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | The cut-off values assessed include 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 immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies. | Posted | Count of Participants | Participants | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
|
|
|
| Secondary | Anti-Tetanus Toxoid (TT) Antibody Concentrations | Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Geometric Mean | 95% Confidence Interval | International Units per milliliter | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
|
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| Secondary | Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Count of Participants | Participants | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) |
|
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| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | The rSBA titers were expressed as geometric mean titers. | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 7 months after vaccination with Nimenrix (At Month 7) |
|
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| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128. | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine. | Posted | Count of Participants | Participants | At 7 months after vaccination with Nimenrix (At Month 7) |
|
|
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| Secondary | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL). | The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies. | Posted | Geometric Mean | 95% Confidence Interval | micrograms per milliliter (µg/mL) | At 7 months after vaccination with Nimenrix (At Month 7) |
|
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| Secondary | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | The cut-off values assessed include 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 immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies. | Posted | Count of Participants | Participants | At 7 months after vaccination with Nimenrix (At Month 7) |
|
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| Secondary | Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine. | Posted | Geometric Mean | 95% Confidence Interval | milli-Internatinal Units per Milliliter | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
|
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| Secondary | Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine. | Posted | Count of Participants | Participants | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
|
|
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| Secondary | IgG Anti-HBs Antibody Concentrations | Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine. | Posted | Geometric Mean | 95% Confidence Interval | milli-Internatinal Units per Milliliter | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
|
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| Secondary | Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine. | Posted | Count of Participants | Participants | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) |
|
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| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed. | Posted | Count of Participants | Participants | During a 4-day period (Days 0-3) after Nimenrix vaccination |
|
|
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| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed. | Posted | Count of Participants | Participants | During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses |
|
|
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| Secondary | Number of Subjects Reporting Any Solicited General Symptoms | Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group. | The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. | Posted | Count of Participants | Participants | During a 4-day period (Days 0-3) after each vaccine dose and across doses |
|
|
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| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered. | Posted | Count of Participants | Participants | Up to 1 month after each vaccine dose |
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|
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| Secondary | Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses | Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies. | The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered. | Posted | Count of Participants | Participants | During the entire study (up to Month 7) |
|
|
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| Secondary | Number of Subjects Reporting Any Rash | Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae. | The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered. | Posted | Count of Participants | Participants | During the entire study (up to Month 7) |
|
|
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| Secondary | Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits | The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered. | Posted | Count of Participants | Participants | During the entire study (up to Month 7) |
|
|
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| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered. | Posted | Count of Participants | Participants | During the entire study (up to Month 7) |
|
|
|
| 0 |
| 367 |
| 4 |
| 367 |
| 312 |
| 367 |
| EG001 | Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. | 0 | 122 | 0 | 122 | 82 | 122 |
| EG002 | Twinrix Group | Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6. | 0 | 122 | 1 | 122 | 100 | 122 |
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
|
| Swelling at the injection site | General disorders | Systematic Assessment | Post-meningococcal vaccination |
|
| Redness at the injection site | General disorders | Systematic Assessment | Post-meningococcal vaccination |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Pain at the injection site | General disorders | Systematic Assessment | Post-Twinrix vaccination |
|
| Swelling at the injection site | General disorders | Systematic Assessment | Post-Twinrix vaccination |
|
| Redness at the injection site | General disorders | Systematic Assessment | Post-Twinrix vaccination |
|
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 |
|
|
| rSBA-MenW-135 |
|
|
| rSBA-MenY |
|
|
| rSBA-MenA ≥ 1:8 [Month 1] |
|
|
| rSBA-MenC ≥ 1:8 [Month 0] |
|
|
| rSBA-MenC ≥ 1:8 [Month 1] |
|
|
| rSBA-MenW-135 ≥ 1:8 [Month 0] |
|
|
| rSBA-MenW-135 ≥ 1:8 [Month 1] |
|
|
| rSBA-MenY ≥ 1:8 [Month 0] |
|
|
| rSBA-MenY ≥ 1:8 [Month 1] |
|
|
| rSBA-MenA ≥ 1:128 [Month 0] |
|
|
| rSBA-MenA ≥ 1:128 [Month 1] |
|
|
| rSBA-MenC ≥ 1:128 [Month 0] |
|
|
| rSBA-MenC ≥ 1:128 [Month 1] |
|
|
| rSBA-MenW-135 ≥ 1:128 [Month 0] |
|
|
| rSBA-MenW-135 ≥ 1:128 [Month 1] |
|
|
| rSBA-MenY ≥ 1:128 [Month 0] |
|
|
| rSBA-MenY ≥ 1:128 [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] |
|
|
| Anti-PSA ≥ 0.3 µg/mL [Month 1] |
|
|
| Anti-PSC ≥ 0.3 µg/mL [Month 0] |
|
|
| Anti-PSC ≥ 0.3 µg/mL [Month 1] |
|
|
| Anti-PSW-135 ≥ 0.3 µg/mL [Month 0] |
|
|
| Anti-PSW-135 ≥ 0.3 µg/mL [Month 1] |
|
|
| Anti-PSY ≥ 0.3 µg/mL [Month 0] |
|
|
| Anti-PSY ≥ 0.3 µg/mL [Month 1] |
|
|
| Anti-PSA ≥ 2.0 µg/mL [Month 0] |
|
|
| Anti-PSA ≥ 2.0 µg/mL [Month 1] |
|
|
| Anti-PSC ≥ 2.0 µg/mL [Month 0] |
|
|
| Anti-PSC ≥ 2.0 µg/mL [Month 1] |
|
|
| Anti-PSW-135 ≥ 2.0 µg/mL [Month 0] |
|
|
| Anti-PSW-135 ≥ 2.0 µg/mL [Month 1] |
|
|
| Anti-PSY ≥ 2.0 µg/mL [Month 0] |
|
|
| Anti-PSY ≥ 2.0 µg/mL [Month 1] |
|
|
| Month 1 |
|
|
| Month 1 |
|
|
| rSBA-MenC |
|
|
| rSBA-MenW-135 |
|
|
| rSBA-MenY |
|
|
| rSBA-MenC ≥ 1:8 |
|
|
| rSBA-MenW-135 ≥ 1:8 |
|
|
| rSBA-MenY ≥ 1:8 |
|
|
| rSBA-MenA ≥ 1:128 |
|
|
| rSBA-MenC ≥ 1:128 |
|
|
| rSBA-MenW-135 ≥ 1:128 |
|
|
| rSBA-MenY ≥ 1:128 |
|
|
| Anti-PSC |
|
|
| Anti-PSW-135 |
|
|
| Anti-PSY |
|
|
| Anti-PSC ≥ 0.3 µg/mL |
|
|
| Anti-PSW-135 ≥ 0.3 µg/mL |
|
|
| Anti-PSY ≥ 0.3 µg/mL |
|
|
| Anti-PSA ≥ 2.0 µg/mL |
|
|
| Anti-PSC ≥ 2.0 µg/mL |
|
|
| Anti-PSW-135 ≥ 2.0 µg/mL |
|
|
| Anti-PSY ≥ 2.0 µg/mL |
|
|
| Month 7 |
|
|
| Month 7 |
|
|
| Month 7 |
|
|
| Month 7 |
|
|
| Swelling |
|
| Any Redness, Dose 1 |
|
|
| Any Swelling, Dose 1 |
|
|
| Any Pain, Dose 2 |
|
|
| Any Redness, Dose 2 |
|
|
| Any Swelling, Dose 2 |
|
|
| Any Pain, Dose 3 |
|
|
| Any Redness, Dose 3 |
|
|
| Any Swelling, Dose 3 |
|
|
| Any Pain, Across doses |
|
|
| Any Redness, Across doses |
|
|
| Any Swelling, Across doses |
|
|
| Any Temperature (Axillary), Dose 1 |
|
|
| Any Gastrointestinal symptoms, Dose 1 |
|
|
| Any Headache, Dose 1 |
|
|
| Any Fatigue, Dose 2 |
|
|
| Any Temperature (Axillary), Dose 2 |
|
|
| Any Gastrointestinal symptoms, Dose 2 |
|
|
| Any Headache, Dose 2 |
|
|
| Any Fatigue, Dose 3 |
|
|
| Any Temperature (Axillary), Dose 3 |
|
|
| Any Gastrointestinal symptoms, Dose 3 |
|
|
| Any Headache, Dose 3 |
|
|
| Any Fatigue, Across doses |
|
|
| Any Temperature (Axillary), Across doses |
|
|
| Any Gastrointestinal symptoms, Across doses |
|
|
| Any Headache, Across doses |
|
|
| Title | Measurements |
|---|---|
|
| Post Dose 3 |
|