Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine | BIOLOGICAL | Intramuscular, single |
| Boostrix™ | BIOLOGICAL | Intramuscular, single dose |
| GSK Biologicals' IPV vaccine | BIOLOGICAL | Intramuscular, single dose |
| Revaxis® | BIOLOGICAL | Intramuscular, single dose |
Inclusion Criteria: * A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination. * Written informed consent obtained. * Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best...
It is an investigational combination vaccine developed by GSK plc that combines reduced antigen diphtheria and tetanus toxoids, acellular pertussis components, and inactivated poliovirus in a single product. It is being studied for protection against tetanus, diphtheria, acellular pertussis, and poliovirus, and is designed to be given as one injection rather than separate vaccines.
It is being developed for immunization against tetanus, diphtheria, acellular pertussis, and poliovirus. The Phase 3 study enrolled participants aged 15 years and older with these conditions as the target indications. The vaccine is intended to provide combined protection in a single administration rather than requiring separate injections for each component.
The vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the company's vaccines unit associated with this product. The Phase 3 trial compared the combination vaccine against Boostrix and inactivated poliovirus vaccine given separately, and also against Revaxis.
The vaccine is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. It is an investigational product and is not described as approved by the FDA. The completed study enrolled 806 participants and used an active-controlled design.
The vaccine has been studied in one completed Phase 3 trial, NCT01277705. That trial compared the reduced antigen diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine against Boostrix and inactivated poliovirus vaccine administered separately, and with Revaxis. It enrolled 806 participants aged 15 years and older, was randomized, and used an active control.
The vaccine is investigational and is not described as FDA approved. It has completed one Phase 3 trial, NCT01277705, which enrolled 806 participants and compared the combination vaccine with Boostrix plus inactivated poliovirus vaccine given separately and with Revaxis. No active trials are currently listed for this product.