CTRI/2014/12/005326已完成3 期
An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of DTwP-Hib vaccine (Easyfour-TT, Panacea Biotec Ltd.) with Quadrovax® (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd.) in Healthy Infants.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 4
- 主要终点
- Proportion of subjects achieving Seroprotection against diphtheria, tetanus, Hib; Seroresponsiveness against pertussis 4 weeks after three dose vaccination series of DTwP-Hib vaccine in the two treatment groups.
研究概览
简要总结
Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of DTwP-Hib vaccine (Easyfour-TT, Panacea Biotec Ltd.) with Quadrovax® (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd.) in Healthy Infants. Primary Objective of this study is to demonstrate non-inferiority of the test vaccine to the reference vaccine, with 90% power and alpha set at 0.025. The study will also evaluate the common local and systemic reactogenicity and safety in the two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 42.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Infants 6-10 weeks of age, whose parents/LAR are willing to give written informed consent prior to the study entry.
- •2.Infants with good health as determined by: •Medical history •Physical examination •Clinical judgment of the investigator 3.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
排除标准
- •1.Infants weighing more than 3.3 Kg at the time of enrollment.
- •2.Infants less than 6 weeks or more than 10 weeks of age.
- •3.Infants having history of immunization with vaccine other than Hep B, IPV or OPV, Pneumococcal, Rotavirus vaccine.
- •4.Infants with history of infection potentially related to any of the agents targeted by the DPT-Hib vaccine 5.Presence of evolving or changing neurological disorder or Infants with history of seizures before receiving the vaccine.
- •Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
- •6.Fever 38o C in past 3 days 7.Any evidence of acute illness or infection within past 7 days.
- •9.Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation.
- •10.Infants who have received any blood products, cytotoxic agents or radiotherapy.
- •11.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •12.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or autoimmune disease under treatment) or major congenital defects, such that it would endanger the volunteer’s well-being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •13.Any evidence of thrombocytopenia or a bleeding disorder.
- •14.Infants who have participated in another trial or received any investigational agent within 30 days of enrolment.
- •15.Infant Parents/LAR Planned participation in another clinical trial during the trial period 16.Infant Parents/LAR is planning to leave the area of study before completion of the study.
结局指标
主要结局
Proportion of subjects achieving Seroprotection against diphtheria, tetanus, Hib; Seroresponsiveness against pertussis 4 weeks after three dose vaccination series of DTwP-Hib vaccine in the two treatment groups.
时间窗: Day 0 and Day 84
次要结局
- unsolicited adverse events (AEs)(Serious Adverse Events (SAEs))
研究者
研究点 (4)
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