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Clinical Trials associated with Haemophilus Influenzae Type b Conjugate Vaccine (Chengda Bio) / Active, not recruitingPhase 1 评价b型流感嗜血杆菌结合疫苗安全性的Ⅰ期和其安全性与免疫原性的随机、盲法、同类疫苗对照的Ⅲ期临床试验
[Translation] Phase I clinical trial to evaluate the safety of Haemophilus influenzae type b conjugate vaccine and a randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate its safety and immunogenicity
Ⅰ期:
评价b型流感嗜血杆菌结合疫苗在2月龄(60~89天)及以上人群中使用的安全性,为Ⅲ期临床试验的开展提供依据。
Ⅲ期:
主要目的:
(1)与对照疫苗比较,评价b型流感嗜血杆菌结合疫苗接种于2月龄(60~89天)(0、1、2月接种程序)、6~11月龄,1~5周岁健康人群后,试验组抗Hib-PRP抗体浓度≥1.0μg/ml的比例是否非劣效于对照组;
(2)与对照疫苗比较,评价b型流感嗜血杆菌结合疫苗的安全性。
[Translation] Phase I:
To evaluate the safety of Haemophilus influenzae type b conjugate vaccine in people aged 2 months (60-89 days) and above, and to provide a basis for the conduct of Phase III clinical trials.
Phase III:
Main objectives:
(1) Compared with the control vaccine, to evaluate whether the proportion of anti-Hib-PRP antibody concentration ≥1.0μg/ml in the test group is non-inferior to that in the control group after Haemophilus influenzae type b conjugate vaccine is administered to healthy people aged 2 months (60-89 days) (0, 1, 2 months vaccination schedule), 6-11 months, and 1-5 years old;
(2) Compared with the control vaccine, to evaluate the safety of Haemophilus influenzae type b conjugate vaccine.
100 Clinical Results associated with Haemophilus Influenzae Type b Conjugate Vaccine (Chengda Bio)
100 Translational Medicine associated with Haemophilus Influenzae Type b Conjugate Vaccine (Chengda Bio)
100 Patents (Medical) associated with Haemophilus Influenzae Type b Conjugate Vaccine (Chengda Bio)
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Literatures (Medical) associated with Haemophilus Influenzae Type b Conjugate Vaccine (Chengda Bio)01 Apr 1992·Archives francaises de pediatrie
Vaccin anti-Haemophilus b.
100 Deals associated with Haemophilus Influenzae Type b Conjugate Vaccine (Chengda Bio)