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The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.
Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC primed Group | Experimental |
| |
| AC unprimed Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanrix™- HepB | Biological | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies | Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128. | At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs | Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128. | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
| Anti-rSBA-MenA, C, W-135 Antibody Titers |
Not provided
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 | Brits | 0250 | South Africa | |||
| GSK Investigational Site |
Not provided
| 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 |
|---|---|---|---|
| 104756 | Study Protocol | 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 | Tritanrix-HepB/Hiberix Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| FG001 | Tritanrix-HepB/Hiberix-Mencevax AC Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Tritanrix-HepB/Hiberix Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left 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 | Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies | Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128. | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31) |
|
Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
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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 | Tritanrix-HepB/Hiberix Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
None reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D014917 | Whooping Cough |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
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| ID | Term |
|---|---|
| C514867 | Hiberix |
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| Hiberix™ | Biological | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
|
| Mencevax™ ACW | Biological | One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months |
|
Antibody titers were expressed as geometric mean titers (GMTs). |
| Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
| Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values | Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL). | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
| Anti-PSA and Anti-PSC Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31 |
| Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values | Antibody concentrations were ≥ 0.3 µg/mL. | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
| Anti-PSW Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
| Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values | Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL). | Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine |
| Anti-HBs Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine |
| Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135 | Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination. | At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
| Number of Subjects With Fever | Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade. | During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine |
| Number of Subjects With Solicited Local Symtoms | Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade. | During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination. | During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From Months 15-18 and up to Months 25-31 post vaccination |
| Ga-Rankuwa |
| 0208 |
| South Africa |
| GSK Investigational Site | Rooihuiskraal | 0145 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104756 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104756 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104756 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104756 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104756 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 | Tritanrix-HepB/Hiberix-Mencevax AC Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Tritanrix-HepB/Hiberix-Mencevax AC Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
|
|
| Secondary | Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs | Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128. | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
|
|
|
| Secondary | Anti-rSBA-MenA, C, W-135 Antibody Titers | Antibody titers were expressed as geometric mean titers (GMTs). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
|
|
|
| Secondary | Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values | Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
|
|
|
| Secondary | Anti-PSA and Anti-PSC Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31 |
|
|
|
| Secondary | Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values | Antibody concentrations were ≥ 0.3 µg/mL. | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
|
|
|
| Secondary | Anti-PSW Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
|
|
|
| Secondary | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values | Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine |
|
|
|
| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine |
|
|
|
| Secondary | Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135 | Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination. | The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) |
|
|
|
| Secondary | Number of Subjects With Fever | Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade. | The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines. | Posted | Number | Subjects | During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine |
|
|
|
| Secondary | Number of Subjects With Solicited Local Symtoms | Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade. | The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in. | Posted | Number | Subjects | During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine |
|
|
|
| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination. | The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in. | Posted | Number | Subjects | During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines. | Posted | Number | Subjects | During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines. | Posted | Number | Subjects | From Months 15-18 and up to Months 25-31 post vaccination |
|
|
|
| 2 |
| 82 |
| 56 |
| 84 |
| EG001 | Tritanrix-HepB/Hiberix-Mencevax AC Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. | 1 | 84 | 56 | 84 |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Redness | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fever/(Rectally) (°C) | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Loss of appetite | General disorders | MedDRA 11.1 | 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 |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001885 | Bordetella Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D016871 | Pasteurellaceae Infections |
| rSBA-MenA ≥1:128 (M24-30) [N=58,53] |
|
| rSBA-MenC ≥1:8 (M24-30) [N=67,61] |
|
| rSBA-MenC ≥1:8 (M25-31) [N=59,66] |
|
| rSBA-MenC ≥1:128 (M24-30) [N=67,61] |
|
| rSBA-MenW-135 ≥1:8 (M24-30) [N=67,63] |
|
| rSBA-MenW-135 ≥1:8 (M25-31) [N=64,66] |
|
| rSBA-MenW-135 ≥1:128 (M24-30) [N=67,63] |
|
| rSBA-MenW-135 ≥1:128 (M25-31) [N=64,66] |
|
| rSBA-MenC (M24-30) [N=67,61] |
|
| rSBA-MenC (M25-31) [N=59,66] |
|
| rSBA-MenW-135 (M24-30) [N=67,63] |
|
| rSBA-MenW-135 (M25-31) [N=64,66] |
|
| anti-PSA ≥ 2 µg/mL (M24-30) [N=63,61] |
|
| anti-PSA ≥ 2 µg/mL (M25-31) [N=65,65] |
|
| anti-PSC ≥ 0.3 µg/mL (M24-30) [N=61,64] |
|
| anti-PSC ≥ 0.3 µg/mL (M25-31) [N=65,66] |
|
| anti-PSC ≥ 2 µg/mL (M24-30) [N=61,64] |
|
| anti-PSC ≥ 2 µg/mL (M25-31) [N=65,66] |
|
| anti-PSC (M24-30) [N=61,64] |
|
| anti-PSC (M25-31) [N=65,66] |
|
| rSBA-MenW-135, Total [N=64,62] |
|
| Any Swelling |
|
| Any Irritability |
|
| Any Loss of appetite |
|