EUCTR2008-000369-44-DEActive, not recruitingNot Applicable
A long-term, open follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine in healthy female subjects up to 10 years after administration of the first vaccine dose in study HPV-013. - HPV-025 EXT 013
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 600
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 and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- •A female enrolled in the immunogenicity subset of study HPV-013, who received three doses of HPV-16/18 VLP/AS04 vaccine and participated in the long-term follow-up study Ext HPV-013.
- •Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or LAR and, in addition, the subject should sign a written informed assent form.
- •Are the trial subjects under 18? yes
- •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
- •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.
- •Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/-18 vaccine administered in study HPV-013.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. (For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.)
- •Administration of immunoglobulins and/or any blood products within the three months preceding study entry.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Follow-up study to evaluate the long-term immunogenicity and safety ofGlaxoSmithKline Biologicals' HPV (580299) vaccine in healthy femalesubjects.EUCTR2009-011357-41-DEGlaxoSmithKline Biologicals667
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 Y5-10For active immunization of women from the age of 10 years onwards to prevent cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.EUCTR2009-011357-41-PLGlaxoSmithKline Biologicals667
Active, not recruiting
Phase 1
Administration of 9valent vaccine against papillomavirus in HIV-positive womeEUCTR2018-000228-33-BECHU Saint-Pierre200
Not yet recruiting
Not Applicable
A study on immunity after Covid 19 vaccineCTRI/2021/07/034663ational Centre for Biological Science
Active, not recruiting
Not Applicable
A Long Term Safety and Effectiveness Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)HPVMedDRA version: 18.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862EUCTR2014-005717-23-Outside-EU/EEAMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,575