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The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INFANRIX HEXA PF GROUP | Experimental | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexaâ„¢ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexaâ„¢ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
|
| INFANRIX HEXA PC GROUP | Experimental | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexaâ„¢ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexaâ„¢ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
|
| CONTROL GROUP | Active Comparator | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexaâ„¢ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexaâ„¢ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrix Hexa | Biological | Vaccine administered as a booster dose at 16-20 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | Before the booster administration (At Month 0) |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. | Before the booster vaccination (At Month 0) |
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8. | Before the booster vaccination (At Month 0) |
| Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL . | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) |
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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 | Jarvenpaa | 04400 | Finland | |||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| 111344 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix Hexa PF Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| FG001 | Infanrix Hexa PC Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| FG002 | Control Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix Hexa PF Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| 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 Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations 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 data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before the booster administration (At Month 0) |
|
Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
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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 | Infanrix Hexa PF Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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|
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8. |
| One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | Before the booster vaccination (At Month 0) |
| Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. | Before the booster vaccination (At Month 0) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. | One month after the booster vaccination (At Month 1) |
| Number of Subjects With a Vaccine Response to PT, FHA and PR | Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).](streamdown:incomplete-link) | One month after the booster vaccination (At Month 1) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | Before the booster vaccination (At Month 0) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | One month after the booster vaccination (At Month 1) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | Before the booster vaccination (At Month 0) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | One month after the booster vaccination (At Month 1) |
| Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | Before the booster vaccination (At Month 0) |
| Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | One month after the booster vaccination (At Month 1) |
| Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | Before the booster vaccination (At Month 0) |
| Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | One month after the booster vaccination (At Month 1) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). | Before the booster vaccination (At Month 0) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | One month after the booster vaccination (At Month 1) |
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. |
| Before (Month 0) and one month after (Month 1) the booster vaccination |
| Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8. | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Number of Seroprotected Subjects Against PT, FHA and PRN | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL . | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | Before (Month 0) and one month after (Month 1) the booster vaccination |
| Number of Subjects With a Vaccine Response to PT, FHA and PR | Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value). | One month after the booster dose (At Month 1) |
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after the booster vaccination |
| Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after the booster vaccination |
| 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 (Day 0-30) follow-up period after the booster vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From Month 0 to Month 1, during the entire study period |
| Number of Subjects Reporting Concomitant Medications | During the 4-day (Days 0-3) follow-up period after the booster vaccination |
| Oulu |
| 90220 |
| Finland |
| GSK Investigational Site | Pori | 28100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Vantaa | 01300 | Finland |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111344 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111344 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111344 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111344 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111344 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111344 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Lost to Follow-up |
|
| BG001 | Infanrix Hexa PC Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| BG002 | Control Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Infanrix Hexa PC Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexaâ„¢ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexaâ„¢ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
|
|
| Primary | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Number of Subjects With a Vaccine Response to PT, FHA and PR | Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).](streamdown:incomplete-link) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before the booster vaccination (At Month 0) |
|
|
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| Primary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | One month after the booster vaccination (At Month 1) |
|
|
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| Primary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before the booster vaccination (At Month 0) |
|
|
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| Primary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after the booster vaccination (At Month 1) |
|
|
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| Primary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | One month after the booster vaccination (At Month 1) |
|
|
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| Primary | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month after the booster vaccination (At Month 1) |
|
|
|
| Primary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before the booster vaccination (At Month 0) |
|
|
|
| Primary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month after the booster vaccination (At Month 1) |
|
|
|
| Secondary | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL . | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Number of Seroprotected Subjects Against PT, FHA and PRN | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL . | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before (Month 0) and one month after (Month 1) the booster vaccination |
|
|
|
| Secondary | Number of Subjects With a Vaccine Response to PT, FHA and PR | Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | One month after the booster dose (At Month 1) |
|
|
|
| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after the booster vaccination |
|
|
|
| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after the booster vaccination |
|
|
|
| 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 was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (Day 0-30) follow-up period after the booster vaccination |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Assessed SAEs 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 subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From Month 0 to Month 1, during the entire study period |
|
|
|
| Secondary | Number of Subjects Reporting Concomitant Medications | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after the booster vaccination |
|
|
|
| 0 |
| 127 |
| 1 |
| 127 |
| 116 |
| 127 |
| EG001 | Infanrix Hexa PC Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 0 | 137 | 2 | 137 | 126 | 137 |
| EG002 | Control Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 0 | 139 | 1 | 139 | 129 | 139 |
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia adenoviral | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Redness | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Fever/(Rectal) | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Loss of appetite | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.1 | 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.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003015 | Clostridium Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Anti-polio 2 |
|
|
| Anti-polio 3 |
|
|
| Anti-polio 2 |
|
|
| Anti-polio 3 |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Anti-PT, S+ |
|
|
| Anti-PT, Total |
|
|
| Anti-FHA, S- |
|
|
| Anti-FHA, S+ |
|
|
| Anti-FHA, Total |
|
|
| Anti-PRN, S- |
|
|
| Anti-PRN, S+ |
|
|
| Anti-PRN, Total |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Anti-polio 2 |
|
|
| Anti-polio 3 |
|
|
| Anti-polio 2 |
|
|
| Anti-polio 3 |
|
|
|
| Anti-T, M0 |
|
|
| Anti-T, M1 |
|
|
|
| Anti HBs ≥ 100 mIU/mL, M0 |
|
|
| Anti HBs ≥ 100 mIU/mL, M1 |
|
|
|
| Anti-polio 2, M0 |
|
|
| Anti-polio 2, M1 |
|
|
| Anti-polio 3, M0 |
|
|
| Anti-polio 3, M1 |
|
|
|
| Anti-FHA, M0 |
|
|
| Anti-FHA, M1 |
|
|
| Anti-PRN, M0 |
|
|
| Anti-PRN, M1 |
|
|
|
| Anti-PRP ≥ 1.0 μg/mL, M0 |
|
|
| Anti-PRP ≥ 1.0 μg/mL, M1 |
|
|
|
| Anti-T, M0 |
|
|
| Anti-T, M1 |
|
|
|
| Anti-FHA, M0 |
|
|
| Anti-FHA, M1 |
|
|
| Anti-PRN, M0 |
|
|
| Anti-PRN, M1 |
|
|
|
|
| Anti-polio 2, M0 |
|
|
| Anti-polio 2, M1 |
|
|
| Anti-polio 3, M0 |
|
|
| Anti-polio 3, M1 |
|
|
|
|
| Anti-PT, Total |
|
|
| Anti-FHA, S- |
|
|
| Anti-FHA, S+ |
|
|
| Anti-FHA, Total |
|
|
| Anti-PRN, S- |
|
|
| Anti-PRN, S+ |
|
|
| Anti-PRN, Total |
|
|
| Title | Measurements |
|---|---|
|
| Any Swelling |
|
| Title | Measurements |
|---|---|
|
| Any Irritability |
|
| Any Loss of Appetite |
|
|