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:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316706
First received: April 19, 2006
Last updated: September 13, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Intraepithelial Neoplasia Papillomavirus Infection |
Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) Biological: Havrix™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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.
| Enrollment: | 1245 |
| Study Start Date: | October 2005 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
|
|
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.
|
Biological: Havrix™
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
|
Eligibility| Ages Eligible for Study: | 10 Years to 14 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316706
Locations
| Colombia | |
| GSK Investigational Site | |
| Bogota, Colombia | |
| GSK Investigational Site | |
| Bogota, Colombia, 805 | |
| Germany | |
| GSK Investigational Site | |
| Deggingen, Baden-Wuerttemberg, Germany, 73326 | |
| GSK Investigational Site | |
| Ettenheim, Baden-Wuerttemberg, Germany, 77955 | |
| GSK Investigational Site | |
| Kehl, Baden-Wuerttemberg, Germany, 77694 | |
| GSK Investigational Site | |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| GSK Investigational Site | |
| Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941 | |
| GSK Investigational Site | |
| Weilheim, Bayern, Germany, 82362 | |
| GSK Investigational Site | |
| Wuerzburg, Bayern, Germany, 97070 | |
| GSK Investigational Site | |
| Buetzow, Mecklenburg-Vorpommern, Germany, 18246 | |
| GSK Investigational Site | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18109 | |
| GSK Investigational Site | |
| Wolfenbuettel, Niedersachsen, Germany, 38302 | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44866 | |
| GSK Investigational Site | |
| Willich, Nordrhein-Westfalen, Germany, 47877 | |
| GSK Investigational Site | |
| Trier, Rheinland-Pfalz, Germany, 54290 | |
| GSK Investigational Site | |
| Brunsbuettel, Schleswig-Holstein, Germany, 25541 | |
| GSK Investigational Site | |
| Flensburg, Schleswig-Holstein, Germany, 24937 | |
| GSK Investigational Site | |
| Harrislee, Schleswig-Holstein, Germany, 24955 | |
| GSK Investigational Site | |
| Husum, Schleswig-Holstein, Germany, 25813 | |
| GSK Investigational Site | |
| Niebuell, Schleswig-Holstein, Germany, 25899 | |
| GSK Investigational Site | |
| Weimar, Thueringen, Germany, 99425 | |
| GSK Investigational Site | |
| Berlin, Germany, 10315 | |
| GSK Investigational Site | |
| Berlin, Germany, 10967 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22307 | |
| Honduras | |
| GSK Investigational Site | |
| Comayaguela, Honduras | |
| Panama | |
| GSK Investigational Site | |
| La Chorrera, Panamá, Panama | |
| Taiwan | |
| GSK Investigational Site | |
| Taipei, Taiwan, 100 | |
| GSK Investigational Site | |
| Tao Yuan County, Taiwan, 333 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00316706 History of Changes |
| Other Study ID Numbers: | 104896 (month 18 FU), 104902, 104904, 104918 |
| Study First Received: | April 19, 2006 |
| Results First Received: | November 12, 2009 |
| Last Updated: | September 13, 2012 |
| Health Authority: | Germany: Land Authority for Health and Social Issues Taiwan: Department of Health United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Prophylaxis HPV-16/18 infections and cervical neoplasia |
Additional relevant MeSH terms:
|
Neoplasms Cervical Intraepithelial Neoplasia Carcinoma in Situ Papillomavirus Infections Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type DNA Virus Infections Virus Diseases Tumor Virus Infections |
ClinicalTrials.gov processed this record on May 23, 2013