Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Papillomavirus

Treatments: Biological: HPV-16/18/31/45 L1 AS04 Formulation 6; Biological: HPV-16/18/31/45 L1 AS04 Formulation 3; Biological: HPV 16/18 L1 AS04; Biological: HPV-16/18/31/45 L1 AS04 Formulation 2; Biological: HPV-16/18/31/45 L1 AS04 Formulation 4; Biological: HPV-16/18/31/45 L1 AS04 Formulation 5; Biological: HPV-16/18/31/45 L1 AS04 Formulation 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231413

2004-003766-14 (EudraCT Number)

102115

Details and patient eligibility

About

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

Enrollment: 383 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A woman between, and including, 18 and 25 years of age at the time of the first vaccination
• Written informed consent from the subject prior to enrolment
• Subject must be free of obvious health problems
• Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion criteria

• Pregnant or breastfeeding
• A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
• Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
• History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
• Previous vaccination against human papillomavirus (HPV)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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383 participants in 7 patient groups

HPV-16/18 Group

Active Comparator group

Description:

Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV 16/18 L1 AS04

HPV-TETRA A Group

Experimental group

Description:

Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV-16/18/31/45 L1 AS04 Formulation 1

HPV-TETRA B Group

Experimental group

Description:

Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV-16/18/31/45 L1 AS04 Formulation 2

HPV-TETRA C Group

Experimental group

Description:

Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV-16/18/31/45 L1 AS04 Formulation 3

HPV-TETRA D Group

Experimental group

Description:

Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV-16/18/31/45 L1 AS04 Formulation 4

HPV-TETRA E Group

Experimental group

Description:

Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV-16/18/31/45 L1 AS04 Formulation 5

HPV-TETRA F Group

Experimental group

Description:

Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Treatment:

Biological: HPV-16/18/31/45 L1 AS04 Formulation 6