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

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.

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 Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Biological: Cervarix TM; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • GSK Investigational Site
  • Delft, Netherlands, 2625 AD
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: April 4, 2007
• First Submitted That Met QC Criteria: April 4, 2007
• First Posted (ESTIMATE): April 5, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 16, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Human Papillomavirus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 109801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 109801
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 109801
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 109801
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 109801
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 109801
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 109801
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register