A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Immunogenicity and interchangeability of two inactivated hepatitis A vaccines
研究概览
简要总结
This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated.
详细描述
This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination
- •Provided birth certification or vaccination card
- •Parent(s) or legal guardian(s) are able to understand and sign the informed consent
排除标准
- •Axillary temperature > 37.0 centigrade at the time of dosing
- •Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- •Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •Autoimmune disease or immunodeficiency
- •Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- •History or family history of convulsions, epilepsy, brain disease and psychiatric
- •History of any blood products within 3 months
- •Administration of any other investigational research agents within 30 days
- •Administration of any live attenuated vaccine within 30 days
- •Administration of subunit or inactivated vaccines within 14 days
- •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
研究组 & 干预措施
Group 1: Healive+Healive
75 subjects to receive two doses of Healive 6 months apart
干预措施: Healive+Healive (Biological)
Group 2: Healive+Havrix
75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart
干预措施: Healive+Havrix (Biological)
Group 3: Havrix+Havrix
75 subjects to receive two doses of Havrix 6 months apart
干预措施: Havrix+Havrix (Biological)
Group 4: Havrix+Healive
75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart
干预措施: Havrix+Healive (Biological)
结局指标
主要结局
Immunogenicity and interchangeability of two inactivated hepatitis A vaccines
时间窗: 7 months
次要结局
- safety of two inactivated hepatitis A vaccines(7 months)