Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix TM; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456807

109801

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. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.

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

Enrollment: 100 patients

Sex: Female

Ages: 26+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female enrolled in study 104820 and who received three doses of study vaccine/control.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Written informed consent obtained from the subject prior to enrolment in this ancillary study.

Exclusion criteria

• Pregnancy.
• Administration of any HPV vaccine other than that foreseen by the study protocol.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
• Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
• Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Cervarix Group

Experimental group

Description:

Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).

Treatment:

Biological: Cervarix TM

Placebo Group

Placebo Comparator group

Description:

Subjects who received 3 doses of placebo during the primary study (NCT00294047).

Treatment:

Biological: Placebo