NCT03183492撤回4 期
Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.
研究概览
简要总结
This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 19 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Written informed consent obtained from the subject prior to performing any study specific procedure
- •A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)
- •Documented administration of 2 doses of Havrix® Junior in the second year of life
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration
排除标准
- •Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
- •Administration of long-acting immune-modifying drugs at any time during the study entry
- •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
- •Administration of any hepatitis A vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
- •Planned enrolment in the Israel Defense Forces within 30 days of study enrolment or activity that would prohibit the subject to return for Visit 2
- •Acute disease and/or fever at the time of enrolment Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity Subjects with a minor illness without fever may be enrolled at the discretion of the investigator
- •Pregnant or lactating female
- •Female planning to become pregnant or planning to discontinue contraceptive precautions
研究组 & 干预措施
HAV Group
Experimental
Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1).
干预措施: Havrix® (Biological)
结局指标
主要结局
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.
时间窗: At the pre-challenge time-point (Day 1)
Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.
Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status.
时间窗: At the pre-challenge time-point (Day 1)
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.
次要结局
- Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose.(30 days (Day 31) after challenge dose)
- Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose.(30 days (Day 31) after challenge dose)
- Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose.(30 days (Day 31) after challenge dose)
- Occurrence of solicited local and general symptoms.(During the 4-day (Days 1-4) follow-up period after the challenge dose)
- Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.(During the 31-day (Days 1-31) follow-up period after the challenge dose)
- Occurrence of Serious Adverse Events (SAEs).(After the challenge dose up to the study end (Days 1-31))
研究者
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