EUCTR2014-000060-17-DE进行中（未招募）不适用
A phase IIIb, open-label, non-randomised, multicentre study to assess the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to a 2-dose schedule in healthy female adolescents or intramuscularly according to a 3-dose schedule in healthy female adults, 6.5 years after first vaccine dose in study HPV-048 PRI (110659). - HPV-081 EXT:048 Y6.5
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 222
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- •- Subjects who completed their primary vaccination and received either two or three doses of GSK Biologicals’ HPV-16/18 vaccine according to a 0,6-months schedule or a 0,1,6-months schedule in the study HPV-048 PRI (110659) (NCT00541970).
- •- A female between, and including, 9 and 14 years of age or 15 and 25 years of age, at the time of first vaccination, depending on which group they belonged to in the study HPV-048 PRI (110659) (NCT00541970), i.e., 9-14 year old subjects should have received two doses of GSK Biologicals’ HPV-16/18 vaccine according to a 0,6-months schedule and 15-25 year old subjects should have received three doses of GSK Biologicals’ HPV-16/18 vaccine according to a 0,1,6-months schedule.
- •- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form.
- •- Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 207
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Child in care
- •- Use of any investigational or non-registered product (drug or vaccine) other than the HPV-16/18 study vaccine administered in the study HPV-048 PRI (110659) (NCT00541970) from the last visit of the primary study up to the current study visit or planned use during the study period.
- •- Administration of any HPV vaccine from the last visit of the primary study up to the current study visit or planned use during the study period.
- •- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within three months prior to blood sampling. Inhaled and topical steroids are allowed.
- •- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study entry, with the exception of routine meningococcal, inactivated influenza, hepatitis B, diphtheria/tetanus and/or diphtheria/tetanus-containing, poliomyelitis and/or pertussis vaccines up to 8 days before study entry. Enrolment will be deferred until the subject is outside of specified window.
- •- 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 vaccine/product.
- •- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •- Cancer or autoimmune disease under treatment.
- •- Administration of immunoglobulins and/or any blood products within the 3 months preceding the blood sampling.
研究者
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