A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age
试验速览
- 阶段
- 3 期
- 入组人数
- 1,560
- 试验地点
- 1
- 主要终点
- Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
研究概览
简要总结
The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.
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
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy permanent residence 2 months to 5 years old.
- •Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- •Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
- •Axillary temperature ≤37.0 ℃.
排除标准
- •History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
- •Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
- •Receipt of blood or blood-derived products in the 3 months preceding vaccination
- •Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
- •Receipt of any live virus vaccine in the 15 days preceding vaccination.
- •Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
- •Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
- •Thrombocytopenia.
- •History of treatment for thyroid gland disease.
- •Functional or anatomic asplenia.
- •History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- •Any condition that, in the judgment of investigator, may affect trial assessment.
研究组 & 干预措施
Act-HIB®
Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.
干预措施: Act-HIB® (Biological)
Minhai-HIB
Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.
干预措施: Minhai-HIB (Biological)
结局指标
主要结局
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
时间窗: 28 days after last dose of primary vaccination
次要结局
- Number of Subjects With Any Solicited Local and General Symptoms(Within 7 days after any vaccination)
- Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations(28 days after last dose of primary vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 28 days after any vaccination)