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human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine · 1 trial · 2 indications
CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. |
| Havrix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine | BIOLOGICAL | Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule |
| hepatitis A inactivated virus vaccine | BIOLOGICAL | Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule |
DISEASE CHARACTERISTICS: •Healthy participants * Deemed to be in good general health by history and physical examination •Resident of Guanacaste Province of Costa Rica and surrounding areas * Must remain a resident for ≥ 6 months after the first study vaccination PATIENT CHARACTERISTICS: Age ...
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It is a preventive vaccine developed for cervical cancer and precancerous cervical conditions. It is designed to protect against disease associated with human papillomavirus types 16 and 18. The Phase 3 study enrolled healthy female participants aged 18 years and older in Costa Rica.
GSK plc, which trades under the ticker GSK, is the developer of the human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine. The company sponsored the Phase 3 trial evaluating the vaccine in healthy female participants for the prevention of cervical intraepithelial neoplasia or cervical cancer.
The human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine has been evaluated in Phase 3 clinical development. Its single registered trial, NCT00128661, is completed, and no trials are currently listed as active. It is an investigational vaccine, not a marketed product.
The vaccine was studied in one Phase 3 trial, NCT00128661, titled Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants. The trial enrolled 7,466 healthy female participants aged 18 years and older in Costa Rica, was randomized, double blind, and active controlled, and is now completed.
The vaccine is a virus-like particle vaccine that combines HPV 16 and HPV 18 L1 virus-like particles with the AS04 adjuvant system. It is designed to stimulate an immune response against these two human papillomavirus types, which are associated with cervical cancer and precancerous cervical conditions.