Approval Probability
TA Base Rate
Adjusted LOA
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Boostrix PolioTM · 1 trial · 4 indications
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 ...
Boostrix Polio is a vaccine used for immunization against acellular pertussis, poliomyelitis, tetanus, and diphtheria. It is being developed for use in children, with a Phase 3 clinical trial evaluating its immunogenicity and safety in 3 and 4-year-old children.
Boostrix Polio is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company conducted a Phase 3 clinical trial to evaluate the vaccine's immunogenicity and safety in young children.
Boostrix Polio is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its immunogenicity and safety in children aged 3 and 4 years.
Boostrix Polio has one completed Phase 3 clinical trial, identified as NCT01245049. This trial, titled "Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children," enrolled 387 participants in the United Kingdom and was active-controlled.
Boostrix Polio is a combination vaccine that includes components for acellular pertussis, poliomyelitis, tetanus, and diphtheria. It is developed by GSK plc and is being studied in a Phase 3 trial for children aged 3 and 4 years.