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Subjects received 3 doses of GSK Biologicals' HPV vaccine · 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 ...
It is a vaccine developed for the prevention of infections associated with papillomavirus. The Phase 3 trial listed for this asset enrolled healthy female volunteers aged 20 years and older in Belgium, evaluating the vaccine in the context of papillomavirus infections and papillomavirus vaccines.
GSK plc, which trades under the ticker GSK, is the developer of this HPV vaccine. The asset is identified in trial records as GSK Biologicals' HPV vaccine (580299), also known as Cervarix.
This HPV vaccine asset is in Phase 3 development. One Phase 3 trial is recorded for it, and that trial has been completed. It was an active-controlled study, and no trials for this asset are currently listed as active.
The recorded trial is NCT00637195, titled Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299). It was a Phase 3, randomized, active-controlled study that enrolled 152 participants in Belgium and has been completed.
Yes. The asset described as subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) is also known as Cervarix. Both names refer to the same GSK papillomavirus vaccine candidate studied in the Phase 3 trial NCT00637195.
The Phase 3 trial NCT00637195 enrolled 152 participants. It was a randomized, active-controlled study conducted in Belgium in healthy female volunteers aged 20 years and older, and it evaluated immunogenicity and safety when the vaccine was co-administered with another commercially available vaccine.