CTRI/2023/08/055993已完成2 期
A prospective multicentre open label randomized active controlled Phase-II study to evaluate safety, tolerability and immunogenicity of inactivated poliomyelitis vaccine (Adsorbed) of Biological E Limited in 6-8 weeks old infants. - None
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
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. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile).
- •2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •3. A male or female healthy infant of either gender between 6-8 weeks of age at the time of 1st vaccination.
- •4. Healthy infants with body weight = 3300 gms at the time of 1st vaccination
- •5. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator.
- •6. Subjects not participating in any other clinical trials.
- •7. Receipt of single birth dose of OPV (within 14 days of birth).
- •8. Infants without contraindications or precautionary circumstances for participating in the trial.
排除标准
- •1.Prior immunization or intent to receive oral/injectable polio vaccine (OPV/IPV) within the study period with an exception of birth dose of oral polio vaccine.
- •2. Current illness (especially fever) or any acute or congenital illness or disability.
- •3. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
- •4.Subjects receiving immunosuppressive therapy
- •5.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •6.Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •7. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
- •8. Known family history of SIDS (Sudden Infant Death Syndrome).
- •9. Planned or elective surgery during the course of the study.
- •10. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
- •11. Subjects and / or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
- •12. Inability or unwillingness of the parent to abide by the requirements of the protocol.
- •13. Family history of congenital or hereditary immunodeficiency.
- •14. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
研究者
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