A Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine (Human Diploid Cell) in Healthy Adults and Children Aged ≥1 Year
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- Seroconversion rate of anti-HAV antibodies
研究概览
简要总结
This is a Phase Ⅲ, open-label, single arm design combined with randomized, double-blind, active-controlled design trial to assess the immunogenicity and safety of different specifications of Healive® (the 0.5 mL pediatric dosage and the 1 mL adult dosage).
A total of 680 healthy participants aged 1 year and above will be enrolled, including 200 participants aged 16 years and older (adult dose group), and 480 participants aged 1 to less than 16 years (pediatric dose group).
For the adult dose group: open-label, single-arm design, 200 participants aged 16 years and above will be enrolled to receive Healive® (1.0 mL).
For the pediatric dose group: double-blinded, randomized, positive-controlled design, 480 participants aged 1 to less than 16 years will be enrolled, and randomized in a 2:1 ratio to receive either Healive® (0.5 mL) or Avaxim® (0.5 mL). All participants will receive two doses of either Healive® or Avaxim® at 0 and 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged 1 year and older;
- •Participants (and/or their legal guardians) are able to understand and sign the informed consent voluntarily;
- •Participants of reproductive potential and their sexual partners should voluntarily use effective contraception from signing the ICF to 30 days after the second vaccination and avoid donating sperm or eggs.
- •Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
- •Participants should agree to comply with the lifestyle precautions outlined in the protocol.
排除标准
- •Prior vaccination with any hepatitis A vaccine or combined vaccines containing HAV components;
- •Prior history of HAV infection;
- •Female participants of reproductive potential who are pregnant (including a positive urine pregnancy test) or have a pregnancy plan within 30 days after the second vaccination, or who are currently lactating;
- •Known allergy to vaccines or vaccines ingredients;
- •Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- •Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
- •Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
- •Current or history of severe neurological diseases [epilepsy, convulsions or seizures (excluding history of febrile seizures)] or psychiatric disorders, or presence of a family history of psychiatric disorders;
- •Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
- •Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
- •Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
- •Receipt of attenuated live vaccines or nucleic acid vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
- •Fever on vaccination day, with axillary temperature >37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
- •Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
- •Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
- •Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.
研究组 & 干预措施
Adult dose, treatment group (≥16 years)
干预措施: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL) (Biological)
Pediatric dose, treatment group (6~ <16 years)
干预措施: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) (Biological)
Pediatric dose, control group (6~ <16 years)
干预措施: Hepatitis A vaccine (inactivated, adsorbed) (Biological)
Pediatric dose, treatment group (1~ <6 years)
干预措施: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) (Biological)
Pediatric dose, conrol group (1~ <6 years)
干预措施: Hepatitis A vaccine (inactivated, adsorbed) (Biological)
结局指标
主要结局
Seroconversion rate of anti-HAV antibodies
时间窗: 30 days after the second vaccination
The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination
次要结局
- Seropositive rate of anti-HAV antibodies(30 days after the second vaccination)
- Geometric mean concentration (GMC) of anti-HAV antibodies(30 days after the second vaccination)
- Geometric mean fold rise (GMFR) of anti-HAV antibodies(30 days after the second vaccination)
- Incidence of adverse events (AE)/adverse reactions (AR)(30 days after each vaccination)
- Incidence of adverse events (AE)/adverse reactions (AR)(7 days after each vaccination)
- Incidence of serious adverse events (SAE)(From first vaccination to 30 days after second vaccination)