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Engerix · 1 trial · 2 indications
A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).
Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| Cervarix™ & Engerix™ Group | EXPERIMENTAL | Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12). |
| Engerix™ Group | ACTIVE_COMPARATOR | Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12). |
| Name | Type | Description |
|---|---|---|
| Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) | BIOLOGICAL | Intramuscular administration, 3 doses. |
| Engerix™ | BIOLOGICAL | Intramuscular administration, 4 doses. |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 20 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from ...
Engerix is a vaccine studied for use in infections and papillomavirus-related conditions. It was evaluated in a Phase 3 clinical trial for its immunogenicity and safety when co-administered with a GSK HPV vaccine. The study involved healthy female volunteers aged 20 years and older.
Engerix is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted a Phase 3 clinical trial to assess the vaccine's safety and immune response when given alongside another GSK product.
Engerix is in Phase 3 clinical development. A Phase 3 trial, NCT00637195, has been completed. This trial evaluated the vaccine's immunogenicity and safety in healthy female participants. Engerix remains an investigational product and has not been reported as approved.
Engerix has one completed Phase 3 clinical trial, NCT00637195, titled "Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)." The trial enrolled 152 healthy female participants aged 20 years and older in Belgium and was actively controlled.
Engerix is not the same as the GSK HPV vaccine. In the clinical trial NCT00637195, Engerix was co-administered with a GSK HPV vaccine (580299) to evaluate their combined use. The trial assessed the immunogenicity and safety of this co-administration in healthy female volunteers.