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Also known as HPV Vaccine (GSK580299) Cervarix TM
HPV Vaccine Cervarix TM · 1 trial · 1 indication
Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.
Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.
Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.
| Arm | Type | Description |
|---|---|---|
| Cervarix & Engerix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) co-administered with Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule. |
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) according to a 0, 1, 6-month schedule. |
| Engerix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule. |
| Name | Type | Description |
|---|---|---|
| HPV Vaccine (GSK580299) Cervarix TM | BIOLOGICAL | IM administration |
| Engerix B | BIOLOGICAL | IM administration |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A fema...
HPV Vaccine Cervarix TM is an investigational vaccine developed by GSK plc for infections and papillomavirus. It is a Phase 3 vaccine candidate studied in healthy female subjects. The clinical program includes one completed Phase 3 trial with 744 participants, conducted in the Netherlands and Sweden.
HPV Vaccine Cervarix TM is being studied for infections and papillomavirus. The completed Phase 3 trial evaluated its immunogenicity and safety when co-administered with another vaccine in healthy female subjects aged 9 years and older. It is an investigational vaccine and is not described as approved.
HPV Vaccine Cervarix TM is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 3 clinical program for this vaccine candidate.
HPV Vaccine Cervarix TM is in Phase 3 development. Its clinical program consists of one completed Phase 3 trial, with no active trials currently listed. The trial enrolled 744 participants and was randomized and active-controlled, though not double-blind.
HPV Vaccine Cervarix TM has been studied in the Phase 3 trial NCT00652938, titled Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects. The trial is completed, enrolled 744 participants, and was conducted in the Netherlands and Sweden.
Yes, HPV Vaccine Cervarix TM is also known as HPV Vaccine (GSK580299) Cervarix TM. GSK580299 is the internal development code for the same vaccine candidate, so both names refer to the same GSK plc Phase 3 product for infections and papillomavirus.