Clinical trial NCT00316706: Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Intraepithelial Neoplasia
Papillomavirus Infection
Keywords: Prophylaxis HPV-16/18 infections and cervical neoplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-21
Enrollment: 1245
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility 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.

Primary outcomes:
measure: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
timeFrame: At 18, 24, 36 and 48 months
Secondary outcomes:
measure: Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up
timeFrame: At Months 18 and 24
measure: Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up
timeFrame: At Month 36 and 48
measure: 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
timeFrame: From Month 18 to Month 24
measure: 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
timeFrame: From Month 24 to Month 48
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Deggingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tauberbischofsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Buetzow
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Brunsbuettel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Harrislee
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Niebuell
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Comayaguela
country: Honduras
facility: GSK Investigational Site
city: La Chorrera
country: Panama
facility: GSK Investigational Site
state: Panamá
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Tao Yuan County
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.