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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01449812 | Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine | PHASE3 | COMPLETED | 831 | — | — | Oct 1, 2011 | Jan 16, 2012 | Jun 6, 2018 | 2 | China |
| NCT00696423 | Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children | PHASE3 | COMPLETED | 467 | — | — | Jun 7, 2008 | Jul 26, 2008 | Jun 6, 2018 | 3 | China |
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Geometric mean concentrations are given in microgram per milliliter (μg/mL).
Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
Geometric mean concentrations are given in IU/mL.
Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| INFANRIX+HIB/POLIORIX 1 GROUP | EXPERIMENTAL | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| INFANRIX+HIB/POLIORIX 2 GROUP | EXPERIMENTAL | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| CONTROL GROUP | ACTIVE_COMPARATOR | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| Infanrix/Hib Single Injection Group | EXPERIMENTAL | Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™. |
| Infanrix + Hiberix Separate Injection Group | ACTIVE_COMPARATOR | Subjects received two separate injections, one of Infanrix™ and one of Hiberix™. |
| Name | Type | Description |
|---|---|---|
| Infanrix+Hib™ | BIOLOGICAL | Intramuscular, one dose |
| Poliorix™ | BIOLOGICAL | Intramuscular, one dose |
| Infanrix™ | BIOLOGICAL | Intramuscular injection, one dose |
| Hiberix™ | BIOLOGICAL | Intramuscular injection, one dose |
Inclusion Criteria: * A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination. * Subjects who completed the full three-dose primary vaccination course in study NCT01086423. * Subjects who the investigator believes that their parent(s)/ Legally A...