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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 a vaccine used for active immunization against acellular pertussis, as well as tetanus, diphtheria, and poliomyelitis. It is intended as a booster dose in children aged 5 to 6 years. The vaccine is being developed by GSK plc for the prevention of these infectious diseases.
Boostrix Polio 711866 is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in clinical development for use as a booster dose against acellular pertussis, tetanus, diphtheria, and poliomyelitis in children.
Boostrix Polio 711866 is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its immunogenicity and safety as a booster dose in children aged 5 to 6 years.
Boostrix Polio 711866 has been studied in one completed Phase 3 clinical trial, identified as NCT00871000. This trial assessed the immunogenicity and safety of the vaccine as a booster dose in 303 children aged 5 to 6 years in Italy. The trial was active-controlled and enrolled healthy volunteers.
Boostrix Polio 711866 is a vaccine that works by stimulating the immune system to produce antibodies against the bacteria and viruses that cause acellular pertussis, tetanus, diphtheria, and poliomyelitis. It is designed to boost immunity in children who have previously received primary vaccination series.