TCTR20190201001已完成1 期
Immunogenicity and Safety of recombinant acellular pertusis-containing vaccine (TdaP) and a pedriatric recombinant acellular pertussis-containing vaccine (DTaP) in healthy children
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 151
研究概览
简要总结
Both Boostagen and the recombinant DTaP vaccines are safe and highly immunogenic in children aged 3 to 7 years. These two recombinant vaccines showed similar tolerability and safety profile to the licensed DTaP-IPV vaccine, Tetraxim.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3 Years 至 7 Years（—）
- 性别
- All
入选标准
- •Participants will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
- •1. 3 to 7 years of age (less than 8 years full of age);
- •2. Having completed the 4-dose DTwP vaccination according to Thai EPI;
- •3. Able to provide written informed assent and parents or legal guardians of the participant can provide written informed consent;
- •4. Healthy, as established by pertinent medical history and physical examination;
- •5. Capable of complying with the study protocol within the investigator's judgment.
- •6. Parents or legal guardians must be able to read and write in Thai.
排除标准
- •A participant with ANY of the following criteria at study entry will not be eligible for participation:
- •1. History of any significant medical illness such as, but not limited to, immune deficiency, renal, hepatic, cardiovascular, or endocrine disorder as determined by the investigator based on medical history and physical examination;
- •2. History of allergy or hypersensitivity to any vaccine (including its component);
- •3. History of any serious adverse event or neurological adverse event after vaccination;
- •4. Having received diphtheria or tetanus or pertussis vaccine within 1 year prior to recruitment;
- •5. Having experienced a physician diagnosed diphtheria or tetanus or pertussis illness within 1 year prior to recruitment;
- •6. Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines);
- •7. Planning to receive tetanus, diphtheria or pertussis vaccines or planning to participate in another clinical trial during the study period (approximately 6 months);
- •8. Receipt of blood or blood component or immunoglobulin within 3 months prior to recruitment;
- •9. History of receiving any immunosuppressive drug or systemic corticosteroid (more than 0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment;
- •10. Any bleeding disorder;
- •11. Any abnormality of splenic or thymic function;
- •12. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barr syndrome;
- •13. History of any illness including cognitive impairment and psychiatric disease that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- •14. Fever as defined by body temperature more than 38 degree celsius at the time of enrollment (temporary exclusion criterion).
研究者
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