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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00871000 | Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children. | PHASE3 | COMPLETED | 303 | — | — | Apr 1, 2009 | Nov 18, 2009 | Jun 6, 2018 | 8 | Italy |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.
A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| BOOSTRIX POLIO GROUP | EXPERIMENTAL | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
| TETRAVAC GROUP | ACTIVE_COMPARATOR | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
| Name | Type | Description |
|---|---|---|
| Boostrix Polio™ 711866 | BIOLOGICAL | Single dose, intramuscular administration. |
| Priorix Tetra TM 208136 | BIOLOGICAL | Single dose, subcutaneously. |
| Tetravac TM | BIOLOGICAL | Single dose, intramuscular administration. |
Inclusion Criteria: * A male or female child of 5 and 6 years of age at the time of vaccination. * Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy. * Subjects who received a first dose ...