Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | dTPa vaccine |
| Group B | EXPERIMENTAL | Pa vaccine |
| Group C | ACTIVE_COMPARATOR | Tedivax-Adult™/ Td-Rix™ |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine | BIOLOGICAL | Intramuscular, single dose |
| GSK Biologicals' reduced-antigen-content acellular pertussis vaccine | BIOLOGICAL | Intramuscular, single dose |
| Tedivax-Adult™/ Td-Rix™ | BIOLOGICAL | Intramuscular, single dose or 2 doses (in the annex phase) |
Inclusion Criteria: * A male or female aged ≥18 years at the time of vaccination * Free of obvious health problems as established by medical history and clinical examination before entering into the study * Written informed consent obtained from the subject * If the subject is female, she must be o...
It is a vaccine developed by GSK plc (ticker GSK) for protection against diphtheria, tetanus, and pertussis. It is a reduced-antigen-content formulation, meaning it contains lower amounts of antigens than standard formulations. It is an investigational product that has been studied in a Phase 3 clinical trial.
It is intended for immunization against diphtheria, tetanus, and pertussis. The Phase 3 trial enrolled healthy adult volunteers aged 18 years and older. The vaccine is designed to provide protection against these three infectious diseases.
The vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division of GSK plc. The company is responsible for the development and clinical study of this reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine candidate.
The vaccine has been studied in a Phase 3 clinical trial. That trial is listed as completed. It is an investigational vaccine and is not described as approved by the FDA. The Phase 3 study evaluated the vaccine in healthy adult volunteers.
The vaccine was evaluated in a Phase 3 trial registered as NCT01262924, titled Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine. The trial enrolled 116 participants aged 18 years and older, was randomized and active-controlled, and is now completed.