EUCTR2009-011357-41-PLActive, not recruitingNot Applicable
A long-term, open, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in healthy female subjects up to 10 years after administration of the first vaccine dose in study HPV 014. - HPV-060 EXT 014 Y5-10
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 667
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •A female who enrolled in study HPV-014 and received three doses of HPV-16/18 vaccine.
- •Written informed consent obtained from the subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- •Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. For corticosteroids, this will mean prednisone, >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •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).
- •Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- •Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in study HPV 014.
Investigators
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