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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01245049 | Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children | PHASE3 | COMPLETED | 387 | — | — | Apr 1, 2011 | Apr 2, 2012 | Aug 17, 2018 | 13 | United Kingdom |
Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Antibody titers were presented as geometric mean titers (GMTs).
| Arm | Type | Description |
|---|---|---|
| BOOSTRIX POLIO GROUP | EXPERIMENTAL | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. |
| REPEVAX GROUP | ACTIVE_COMPARATOR | Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. |
| Name | Type | Description |
|---|---|---|
| Boostrix PolioTM | BIOLOGICAL | Single dose, intramuscular administration. |
| RepevaxTM | BIOLOGICAL | Single dose, intramuscular administration. |
| PriorixTM | BIOLOGICAL | Single dose, intramuscular or subcutaneous administration. |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female child of 3 or 4 years of age at the time of booster vaccination ...