Cervical Intraepithelial NeoplasiaPhase 3NCT00316706
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
A Phase 3 study testing GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) and Havrix™ in people with Cervical Intraepithelial Neoplasia and Papillomavirus Infection, run by GlaxoSmithKline at 28 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Papillomavirus Infection
- What is being tested?
- GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) and Havrix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,245 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Oct 2005to Jan 2009
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
Germany22 sites
GSK Investigational Site
Berlin, State of Berlin, 10315
GSK Investigational Site
Berlin, State of Berlin, 10967
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22307
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18109
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Weilheim, Bavaria, 82362
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Würzburg, Bavaria, 97070
Colombia2 sites
GSK Investigational Site
Bogotá, 805
GSK Investigational Site
Bogotá
Taiwan2 sites
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Tao Yuan County, 333
About this study
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
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.
- Being tested
- GSK Biologicals' HPV-16/18 Vaccine (Cervarix™), Havrix™
- Keywords
- Prophylaxis HPV-16/18 infections and cervical neoplasia
- Medical subject headings
- Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)Biological
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
Havrix™Biological
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix Group | Experimental | 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. Receives: Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) |
| Havrix Group | Active comparator | 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. Receives: Biological: Havrix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Measured: At 18, 24, 36 and 48 months
Secondary outcomes (4)
Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Measured: At Months 18 and 24
Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Measured: At Month 36 and 48
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
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.
Measured: From Month 18 to Month 24
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
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.
Measured: From Month 24 to Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316706
- Sponsor's protocol ID
- 104896 (month 18 FU)
- Other IDs
- 104902, 104904, 104918
- Status last verified
- Sep 2012
- First submitted
- 19 Apr 2006
- Last updated
- 18 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 22265115