Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Papillomavirus Vaccines; Infections, Papillomavirus

Treatments: Biological: HPV investigational vaccine GSK568893A, different formulations; Biological: CervarixTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359619

2004-003766-14 (EudraCT Number)

107921 (Other Identifier)

107918 (Other Identifier)

108052 (FU month 18)

107919 (Other Identifier)

Details and patient eligibility

About

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 383 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female who enrolled in the study 102115 and received three doses of vaccine.
• Written informed consent obtained from the subject prior to enrolment.

Exclusion criteria

• Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
• Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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383 participants in 7 patient groups

Cervarix Group

Active Comparator group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: CervarixTM

Cervarix 1 Group

Experimental group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 2 Group

Experimental group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 3 Group

Experimental group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 4 Group

Experimental group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 5 Group

Experimental group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: HPV investigational vaccine GSK568893A, different formulations

Cervarix 6 Group

Experimental group

Description:

Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Treatment:

Biological: HPV investigational vaccine GSK568893A, different formulations