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Evaluation of Long-Term Immunogenicity and Safety of a HPV Vaccine in Healthy Female Subjects.
This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, April 2009
First Received: March 26, 2009   Last Updated: April 30, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00877877
  Purpose

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120.

The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).


Condition Intervention Phase
Human Papillomavirus Infection
 Procedure: Blood sampling
 Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Follow-up Study to Evaluate the Long-Term Immunogenicity and Safety of a HPV Vaccine (580299) in Healthy Female Subjects.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HPV-16/18 antibody titres and seroconversion rates [ Time Frame: Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-HPV-16/18 antibody titres and seroconversion rates from efficacy studies (580299/001, 580299/007, 109616 (Y7), 109624 (Y8) and 109625 (Y9)) [ Time Frame: Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 antibody titres elicited after natural infection (study 580299/008) [ Time Frame: Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study period ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group HPV Procedure: Blood sampling
Blood samples will be collected at Months 60, 72, 84, 96, 108 and 120

Detailed Description:

Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
  • Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
  • Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
  • Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
  • Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877877

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Colombia
GSK Investigational Site
Bogota, Colombia
Germany
GSK Investigational Site
Berlin, Germany, 10967
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Hamburg, Germany, 22307
Germany, Baden-Wuerttemberg
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Germany, Bayern
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
Germany, Mecklenburg-Vorpommern
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Germany, Niedersachsen
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Germany, Nordrhein-Westfalen
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Germany, Rheinland-Pfalz
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Germany, Schleswig-Holstein
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
GSK Investigational Site
Harrislee, Schleswig-Holstein, Germany, 24955
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Germany, Thueringen
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
Panama
GSK Investigational Site
Ciudad de Panama - La Chorrera, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111375
Study First Received: March 26, 2009
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00877877     History of Changes
Health Authority: Colombia: INVIMA;   Germany: Paul-Ehrlich-Institut;   Honduras: UNAH;   Panama: Instituto Conmemorativo Gorgas de Estudios de la Salud. Comité Nacional de Bioética de la Investigación;   Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:
HPV vaccine
cervical cancer

Study placed in the following topic categories:
Virus Diseases
Skin Diseases, Infectious
Warts
Skin Diseases
 DNA Virus Infections
Papillomavirus Infections
Healthy

Additional relevant MeSH terms:
Skin Diseases, Viral
Virus Diseases
Skin Diseases, Infectious
Neoplasms
Warts
 Skin Diseases
Tumor Virus Infections
DNA Virus Infections
Papillomavirus Infections
Infection

ClinicalTrials.gov processed this record on May 07, 2009



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