A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 546
- 主要终点
- The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
研究概览
简要总结
To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Days 至 80 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers
排除标准
- •Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
- •History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
- •Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
- •Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
- •Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
- •Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
- •Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
- •Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits
结局指标
主要结局
The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
时间窗: 11 months (1 month after the third dose)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
时间窗: 11 months (1 month after the third dose)
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
次要结局
- The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences(0-11 months (recorded from first dose until the participant completes or discontinues))
- The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.(11 months (1 month after the third dose))
- The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.(11 months (1 month after the third dose))