Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date12 May 2023 |
Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Randomized, Single-arm, Phase Ⅰ Clinical Trial to Evaluate the Safety of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried Vaccinated With Different Immunization Schedule in People Aged 10-60 Years
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies.
Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.
Immunogenicity and Safety of a Quadrivalent Influenza Virus Subunit Vaccine in Subjects Aged 6-35 Months : A Randomized, Double-blind, Active-controlled Phase III Trial
A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months.
A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart.
Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered.
Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection.
Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.
评价四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性的随机、盲法、阳性对照Ⅲ期临床试验
[Translation] A randomized, blinded, positive-controlled phase III clinical trial evaluating the safety and immunogenicity of quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months
主要目的:评价0.5ml/支四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性。次要目的:评价0.25ml/支四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性。探索性目的:1.比较 0.5ml/支与 0.25ml/支四价流感病毒亚单位疫苗在 6-35 月龄健康人群中接种后的安全性和免疫原性的差异;2.探索 0.5ml/支与 0.25ml/支四价流感病毒亚单位疫苗在 6-35 月龄健康人群中全程接种后的 3 个月和 6 个月免疫持久性。
[Translation] Main purpose: To evaluate the safety and immunogenicity of 0.5ml/cartage of quadrivalent influenza virus subunit vaccine after inoculation in healthy people aged 6-35 months. Secondary objective: To evaluate the safety and immunogenicity of 0.25ml/dose of quadrivalent influenza virus subunit vaccine after inoculation in healthy people aged 6-35 months. Exploratory purposes: 1. To compare the safety and immunogenicity of 0.5ml/bottle and 0.25ml/bottle quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months; 2. To explore the difference of 0.5ml/bottle Immunity persistence at 3 months and 6 months after full inoculation with 0.25ml/tube quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months.
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