PER-004-06已完成未知
PHASE III, DOUBLE-BLIND, RANDOMIZED, CONTROLLED STUDY TO EVALUATE THE SECURITY, IMMUNOGENICITY AND EFFICACY OF THE VACCINE VPH-16/18 L1 / AS04 OF GLAXOSMITHKLINE BIOLOGICALS, OF INTRAMUSCULAR ADMINISTRATION, IN ACCORDANCE WITH A THREE-DOSE SCHEME (0, 1 , 6 MONTHS) IN HEALTHY ADULT WOMEN 26 YEARS OF AGE AND OLDER
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 178
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. A woman who can and will comply with the requirements of the protocol.
- •2. A woman of at least 26 years of age at the time of the first vaccination.
- •3. Written informed consent obtained from the subject before being recruited.
- •4. Be free of obvious health problems.
- •5. The subject must have an intact cervix.
- •6. The subject must have a negative urine pregnancy test.
- •7. The subject should not have potential for maternity / fertility or, if the patient has fertility potential, should practice abstinence or should be using an effective method for birth control for 30 days before the first vaccination and should agree to continue with these precautions for two months after completing the vaccination series.
排除标准
- •1. Pregnancy or lactation.
- •2. A woman who intends to become pregnant, who is likely to become pregnant or who plans to discontinue contraceptive precautions during the vaccination phase of the study.
- •3. Use of any investigational or unregistered product other than study vaccines within 30 days prior to the first dose.
- •4. Chronic administration of immunosuppressants or other medications that modify the immune system in the six months prior to the first dose of vaccine.
- •5. Administration of a vaccine not foreseen by the study protocol in the 30 days before and after the administration of the first dose of the study vaccine.
- •6. Previous administration of MPL® or adjuvant AS04.
- •7. Prevaccination against HPV.
- •8. History of infection / previous treatment of HPV or treatment to evaluate an abnormal cervical cytology test.
- •9. Any suspected immunosuppressed or medically diagnosed condition.
- •10. History of allergic disease, suspected allergy or reactions that are likely to be exacerbated by any component of the study vaccines.
- •11. Hypersensitivity to latex.
- •12. Known functional abnormality, acute or chronic, clinically significant, neurological, hepatic or renal.
- •13. History of chronic conditions that require treatment.
- •14. Administration of immunoglobulins and / or any blood product in the three months prior to the first dose of the study vaccine, or its planned administration during the study period.
- •15. Acute disease at the time of recruitment.
- •16. Considerable bleeding or significant vaginal discharge.
研究者
相似试验
进行中（未招募）
1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIPEUCTR2009-009318-41-FRPfizer Inc., 235 East 42nd Street, New York, NY 10017600
进行中（未招募）
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIPOsteoarthritis of the knee or hipMedDRA version: 9.1Level: LLTClassification code 10020108Term: Hips osteoarthritisMedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritisEUCTR2009-009318-41-ATPfizer Inc., 235 East 42nd Street, New York, NY 10017600
进行中（未招募）
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIPEUCTR2009-009318-41-GBPfizer Inc., 235 East 42nd Street, New York, NY 10017600
进行中（未招募）
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIPOsteoarthritis of the knee or hipMedDRA version: 9.1Level: LLTClassification code 10020108Term: Hips osteoarthritisMedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritisEUCTR2009-009318-41-SEPfizer Inc., 235 East 42nd Street, New York, NY 10017600
进行中（未招募）
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIPOsteoarthritis of the knee or hipMedDRA version: 9.1Level: LLTClassification code 10020108Term: Hips osteoarthritisMedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritisEUCTR2009-009318-41-DEPfizer Inc., 235 East 42nd Street, New York, NY 10017600