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

Phase 3

Completed

• Conditions: Infections, Papillomavirus
• Interventions: Biological: Cervarix TM; Biological: Placebo

• Registration Number: NCT00456807
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-05
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-11-12
• Results First Submitted QC: 2010-06-29
• Results First Posted: 2010-07-30
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervarix Group	Cervarix TM	Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Placebo Group	Placebo	Subjects who received 3 doses of placebo during the primary study (NCT00294047).

Primary Outcome Measures

Name	Time	Method
Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines	At Month 12 and Month 18 after first vaccination	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.
Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18	At Month 12 and Month 18 after first vaccination	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.
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values	At Month 12 and Month 18 after first vaccination	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.
Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies	At Month 12 and Month 18 after first vaccination	Titers are presented as Geometric Mean Titers (GMTs).
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies	At Month 12 and Month 18 after first vaccination	Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples	At Month 12 and Month 18 after first vaccination	Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Delft, Netherlands