NCT04056728Unknown4 期
A Prospective, Open-label, Interventional Phase IV Study to Assess the Safety of EupentaTM Inj. {Fully Liquid Pentavalent Vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [Recombinant-deoxyribonucleic Acid])-Haemophilus Influenzae Type b Conjugate Vaccine}
LG Chem0 个研究点目标入组 3,000 人开始时间: 2019年9月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 3,000
- 主要终点
- Incidence of solicited local and systemic adverse events (AEs)
研究概览
简要总结
A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine}
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained from the parents or legally acceptable representatives (LARs) of the subject who have been informed of the purpose, method, effects, etc., of the study
- •A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination
- •In good health as determined by medical history, physical examination, and judgment by the Investigator
- •Body weight 3.2 kg and over at the time of screening
- •Subjects for whom the Investigator believed that their parent(s)/LAR(s) could comply with the requirements of the protocol (e.g., completion of the Subject Diary Cards, return for site visits)
排除标准
- •Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases
- •Any history of allergy to any of the components or excipients of EupentaTM Inj., including aluminum hydroxide, sodium hydrogen phosphate heptahydrate, monobasic sodium phosphate dihydrate, polysorbate and thimerosal
- •Any medical condition which can compromise the infant's safety, as per Investigator's discretion
- •History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality
- •History of bleeding tendencies
- •Household contact and/or intimate exposure with a confirmed case of diphtheria, pertussis, HB, polio and/or Hib diseases within in 30 days prior to screening
- •History of fever ≥ 38°C/ 100.4°F within 3 days prior to screening and/or intake of anti-pyretic/analgesic medication. Subjects who meet this criterion will be rescreened to check the temperature after the temporary condition has resolved and if they are within the window period for age of first vaccination at the time of re-scheduled visit
- •History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses
- •History of previous or concurrent vaccinations other than Bacillus Calmette-Guérin (BCG), HB vaccination at birth, Polio, Rotavirus and Pneumococcal vaccines
- •Known or suspected immune disorders, or, received immunosuppressive therapy
- •Participation 30 days prior to screening in the study or simultaneously in another study and/or received any investigational product
研究组 & 干预措施
Eupenta Inj.
Experimental
干预措施: Eupenta Inj. (Biological)
结局指标
主要结局
Incidence of solicited local and systemic adverse events (AEs)
时间窗: baseline(pre-vaccination) up to 7 days after each vaccination
Incidence of any unsolicited AEs during the entire study
时间窗: through study completion, an average of 1 year
Incidence of SAEs during the entire study period
时间窗: through study completion, an average of 1 year
Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination
时间窗: first 30 minutes after each study vaccination
次要结局
未报告次要终点
研究者
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