A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
研究概览
简要总结
This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.
详细描述
This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
- •Temperature less than 100.4 °F on day of vaccination
- •Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
- •In good health
排除标准
- •History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
- •Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
- •Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
- •Prior history of herpes zoster
- •Prior receipt of any varicella or zoster vaccine
- •Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination
- •On immunosuppressive therapy
- •Known or suspected immune dysfunction
- •Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
- •Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
- •Not ambulatory
- •Pregnant or breastfeeding
- •Use of nontopical antiviral therapy with activity against herpes viruses
- •Active untreated tuberculosis
结局指标
主要结局
Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
时间窗: Baseline and 6 weeks following vaccine administration
VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
Number of Participants Reporting an Adverse Experience (AE)
时间窗: Up to 42 days following vaccine administration
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Number of Participants Reporting a Serious Adverse Experience (SAE)
时间窗: Up to 42 days following vaccine administration
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
Number of Participants Reporting a Serious Adverse Experience
时间窗: Within 5 days after the blood draw at approximately 20 months following vaccine administration
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
时间窗: Up to 5 days following vaccine administration
The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
Number of Participants Reporting Systemic Adverse Experiences
时间窗: Up to 42 days following vaccine administration
Systemic AEs included all reported AEs except injection-site AEs
Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
时间窗: Up to 42 days following vaccine administration
Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.
次要结局
未报告次要终点