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

Study Overview
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Brief Summary
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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.

Official Title
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Complementary Testing to Further Evaluate the Immunogenicity of a GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Aged Over 26 Years Enrolled in Study 104820.

Conditions
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Infections, Papillomavirus

Intervention / Treatment
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* Biological: Placebo
* Biological: Cervarix TM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervarix Group<br>Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). | Biological: Cervarix TM<br>* Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.<br>* Other names: GSK Biologicals' HPV-16/18 VLP/AS04 vaccine;|
| Placebo Comparator: Placebo Group<br>Subjects who received 3 doses of placebo during the primary study (NCT00294047). | Biological: Placebo<br>* Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Month 12 and Month 18 after first vaccination | 
| Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18 | The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells. An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification. | At Month 12 and Month 18 after first vaccination | 
| Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values | Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. | At Month 12 and Month 18 after first vaccination | 
| Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers are presented as Geometric Mean Titers (GMTs). | At Month 12 and Month 18 after first vaccination | 
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies | Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification. | At Month 12 and Month 18 after first vaccination | 
| Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples | Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated. | At Month 12 and Month 18 after first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus