NCT04073459Unknown2 期
A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series
LG Chem0 个研究点目标入组 336 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 336
- 主要终点
- seroprotection/seroconversion/vaccine-response rate
研究概览
简要总结
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate 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
- 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
- •A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
- •Born at full term pregnancy (Gestational age ≥ 37 weeks)
- •Body weight ≥ 3.2 kg at the time of screening
- •Received one dose of hepatitis B mono-vaccine within seven days of birth
- •Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
- •Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
- •Written informed consent by subject's parent(s) or LAR
排除标准
- •Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
- •History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
- •Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
- •Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
- •Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
- •Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
- •Known or suspected immune disorder or immunodeficient condition
- •Receipt of immunoglobulin or blood-derived product since birth
- •Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
- •History of bleeding disorder contraindicating intramuscular injection
- •Major congenital defects or serious chronic illness
- •History of any neurological disorders or seizures
- •History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
- •History of allergic reactions to latex
- •Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
- •Plan to leave the area of the study site before the end of the study period
- •Infants who are considered unsuitable for the clinical study by the investigator
研究组 & 干预措施
Pentavalent+IPV
Active Comparator
Co-administration of EupentaTM Inj and Imovax Polio
干预措施: Pentavalent vaccine and Salk IPV (Biological)
H dose of Hexavalent
Experimental
High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).
干预措施: DTwP-HepB-Sabin IPV-Hib (Biological)
L dose of Hexavalent
Experimental
Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)
干预措施: DTwP-HepB-Sabin IPV-Hib (Biological)
M dose of Hexavalent
Experimental
Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)
干预措施: DTwP-HepB-Sabin IPV-Hib (Biological)
结局指标
主要结局
seroprotection/seroconversion/vaccine-response rate
时间窗: 4 weeks after three-dose primary series
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
次要结局
- Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL(4 weeks after three-dose primary series)
- Geometric mean concentration (GMC) or Geometric mean titer (GMT)(4 weeks after three-dose primary series)
- Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL(4 weeks after three-dose primary series)
- Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL(4 weeks after three-dose primary series)
- Seroconversion rate against Salk serotypes(4 weeks after three-dose primary series)
- Seroprotection rate against Sabin and Salk serotypes(4 weeks after three-dose primary series)
研究者
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