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

GlaxoSmithKline100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Infections, Papillomavirus

Interventions

Eligibility

Sex: FEMALEMin age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines

The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.