Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Secondary Outcome
Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up
Condition
Cervical Intraepithelial Neoplasia
Intervention
GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Study Arms / Comparison Groups
Cervarix Group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1245
Start Date
October 2005
Completion Date
January 2009
Primary Completion Date
January 2009
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.
Gender
Female
Ages
10 Years - 14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
GSK Clinical Trials, ,
Location Countries
Colombia
Location Countries
Colombia
Administrative Informations
NCT ID
NCT00316706
Organization ID
104896 (month 18 FU)
Secondary IDs
104902
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
September 2012