Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Papillomavirus Vaccines; Infections, Papillomavirus

Treatments: Biological: Cervarix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00250276

2005-001667-58 (EudraCT Number)

104772

Details and patient eligibility

About

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

Enrollment: 798 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to enrolment.
• Subject must have a negative urine pregnancy test.
• Healthy subject before entering the study entry as established by medical history and physical examination.
• Subject must be of non-childbearing potential.

Exclusion criteria

• pregnant or breastfeeding subject.
• previous vaccination against human papillomavirus (HPV).
• Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
• History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

798 participants in 4 patient groups

Cervarix Lot1 Group

Experimental group

Description:

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Treatment:

Biological: Cervarix™

Cervarix Lot2 Group

Experimental group

Description:

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Treatment:

Biological: Cervarix™

Cervarix Lot3 Group

Experimental group

Description:

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Treatment:

Biological: Cervarix™

Cervarix Low Group

Experimental group

Description:

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Treatment:

Biological: Cervarix™