Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01453998 | Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) | PHASE2 | COMPLETED | 657 | — | — | Oct 14, 2011 | Nov 12, 2012 | Jul 17, 2020 | 16 | Dominican Republic, Finland |
| NCT00627458 | Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine | PHASE2 | COMPLETED | 403 | — | — | Feb 1, 2008 | Aug 18, 2008 | Jun 6, 2018 | 6 | Finland |
| NCT00376779 | Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age | PHASE2 | COMPLETED | 450 | — | — | Oct 1, 2006 | May 1, 2007 | Nov 4, 2016 | 6 | Finland |
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
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).
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.
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
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).
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.
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).
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Antibody titers were presented as geometric mean titers (GMTs).
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
| Arm | Type | Description |
|---|---|---|
| GSK217744 Group 1 | EXPERIMENTAL | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| GSK217744 Group 2 | EXPERIMENTAL | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| 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 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. |
| 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 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. |
| 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 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. |
| Name | Type | Description |
|---|---|---|
| Infanrix hexa | BIOLOGICAL | Single dose, licensed formulation, intramuscular into right thigh |
| Prevenar 13 | BIOLOGICAL | Single co-administered dose, intramuscular into left thigh |
| GSK217744 | BIOLOGICAL | Single dose, investigational formulation A or B, intramuscular into right thigh |
| Infanrix hexa Vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine. * A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination. * Subjects who the inves...