EUCTR2009-011357-41-DE
Active, not recruiting
Not 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
DrugsCervarix
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 667
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 647
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
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\.
Outcomes
Primary Outcomes
Not specified
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