Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316706
First received: April 19, 2006
Last updated: September 13, 2012
Last verified: September 2012

April 19, 2006
September 13, 2012
October 2005
January 2009   (final data collection date for primary outcome measure)
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At 18, 24, 36 and 48 months ] [ Designated as safety issue: No ]
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Complete list of historical versions of study NCT00316706 on ClinicalTrials.gov Archive Site
  • Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up [ Time Frame: At Months 18 and 24 ] [ Designated as safety issue: No ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
  • Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up [ Time Frame: At Month 36 and 48 ] [ Designated as safety issue: No ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
  • Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up [ Time Frame: From Month 18 to Month 24 ] [ Designated as safety issue: No ]

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.

  • Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up [ Time Frame: From Month 24 to Month 48 ] [ Designated as safety issue: No ]

    Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.

  • "Safety of HPV vaccine in entire study period and long-term follow-up. Vaccine immunogenicity in primary phase and during long-term follow-up phase.
  • "
Not Provided
Not Provided
 
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013

This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cervical Intraepithelial Neoplasia
  • Papillomavirus Infection
  • Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
    Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
  • Biological: Havrix™
    Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
  • Experimental: Cervarix Group
    Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
    Intervention: Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
  • Active Comparator: Havrix Group
    Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
    Intervention: Biological: Havrix™
Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1245
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
  • Written informed assent obtained from the subject and written informed consent 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 (pharmaceutical product or device).
  • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.
Female
10 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia,   Germany,   Honduras,   Panama,   Taiwan
 
NCT00316706
104896 (month 18 FU), 104902, 104904, 104918
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP