Approval Probability
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Also known as dTpa-IPV
Boostrix Polio 711866 · 1 trial · 4 indications
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 ...
Boostrix Polio 711866 is an investigational vaccine developed by GSK plc for acellular pertussis. It is studied as a booster dose in young children and targets protection against pertussis along with tetanus, diphtheria, and poliomyelitis. It is in Phase 3 clinical development.
Boostrix Polio 711866 is being developed for acellular pertussis, with the studied use being a booster dose in children aged 5 to 6 years. The completed Phase 3 trial also listed tetanus, diphtheria, and poliomyelitis among the conditions evaluated.
Boostrix Polio 711866 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program studying this vaccine candidate for acellular pertussis and related infectious disease indications.
Boostrix Polio 711866 is in Phase 3 clinical development. It is an investigational vaccine candidate and is not described as approved. One Phase 3 trial has been completed, and no trials are currently active.
Boostrix Polio 711866 has been studied in one completed Phase 3 trial, NCT00871000, titled Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children. It enrolled 303 participants in Italy, was randomized and active controlled, and included healthy volunteers.