CTRI/2018/10/015875已完成1 期
A Phase I, Prospective, Open Label Clinical Study to Assess the Safety andImmunogenicity of DTwP-HepB-IPV-Hib Vaccine Manufactured by SIIPL in HealthyToddlers aged 16-24 Months
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subject between 16-24 months of age whose parent has signed the written informed consent.
- •2. Subject with good health as determined by the medical history, physical examination and clinical judgment of the Investigator
- •3. Subject who have completed primary immunization series against Diphtheria, tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b infections and poliomyelitis (OPV and/or IPV) and have not received the booster dose scheduled at 16-18 months of age.
- •4. Subjects with weight-for-length z-score >=-2 SD.
排除标准
- •1. History of Diphtheria/ Tetanus/ Pertussis/ Haemophilus influenzae type b/Hepatitis B/ Poliomyelitis, Infection(s) (confirmed either
- •clinically, serologically or microbiologically).
- •2. Presence of evolving or changing neurological disorder or subject with history of seizures and/or encephalopathy.
- •3. Subject who have received any vaccination during the last 4 weeks
- •4. Subject with history of anaphylaxis, or any serious/life threatening vaccine reaction, or allergy to any vaccine or constituent of study
- •5. Subject having any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) such that it would endanger the well-being or which, in the
- •opinion of the Investigator, might interfere with the evaluation of the study objectives.
- •6. Subject with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or received immunosuppressive therapy within 1 month prior to study entry (For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day or equivalent. However, inhaled or topical steroids are allowed.) or those
- •who have received a parenteral immunoglobulin preparation.
- •7. History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
- •8. Known thrombocytopenia or a bleeding disorder.
- •9. Planned or elective surgery during the course of the study.
- •10. Fever > 38°C/ >100.4°F in past 7 days and/or any evidence of acute illness or infection within past 7 days.
- •11. Receipt any oral or injectable antibiotics from 7 days before the enrolment.
- •12. Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in
- •another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
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