Trial record 16 of 381 for:    (human papillomavirus OR hpv) AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00456807
First received: April 4, 2007
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus (HPV) Infection
Papillomavirus Vaccines
Cervical Neoplasia
Biological: Placebo
Biological: Cervarix TM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines [ Time Frame: At Month 12 and Month 18 after first vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Month 12 and Month 18 after first vaccination ] [ Designated as safety issue: No ]

    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 [ Time Frame: At Month 12 and Month 18 after first vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Month 12 and Month 18 after first vaccination ] [ Designated as safety issue: No ]
    Titers are presented as Geometric Mean Titers (GMTs).

  • Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies [ Time Frame: At Month 12 and Month 18 after first vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Month 12 and Month 18 after first vaccination ] [ Designated as safety issue: No ]
    Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.


Enrollment: 100
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   26 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456807

Locations
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1007 MB
GSK Investigational Site
Delft, Netherlands, 2625 AD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00456807     History of Changes
Other Study ID Numbers: 109801
Study First Received: April 4, 2007
Results First Received: November 12, 2009
Last Updated: March 17, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Human Papillomavirus

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014