CTRI/2019/04/018677已完成1 期
An Open Labeled, Single Arm (Non-Comparative), Prospective Phase I Clinical Study To Evaluate The Safety, Tolerability And Immunogenicity Of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11-Valent Of Panacea Biotec Ltd. In Healthy 12-23 Months Old PCV- naïve Toddlers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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.Healthy PCV-naïve toddler between 12-23 months of age (Both Inclusive) on the day of enrollment. PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
- •2.Toddlers whose parents/LAR willing to audio visual consent process and give written informed consent prior to the study entry.
- •3.Toddlers with an up-to-date minimal vaccination status for their age at the time of enrollment (â??minimalâ??defined as single dose of BCG, 3 doses of Polio vaccine, DPT, Hepatitis B and single dose of Measles at the time of enrollment).
- •4.Toddlers with good health as determined by:
- •4.1 Medical history
- •4.2 Physical examination
- •4.3 Clinical judgment of the investigator
- •5.Toddlers judged to be able to attend all scheduled study visits and to comply with trial procedures.
排除标准
- •1.History of culture-proven invasive disease caused by S. pneumoniae.
- •2.Toddler who have received any pneumococcal vaccine prior to enrollment.
- •3.History of Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C in toddler.
- •4.Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drug within the 6 months prior to administration of the study vaccine. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day or equivalent.
- •5.Administration of immunoglobulins and/or any blood products
- •during the period starting three months before the administration of study vaccine or planned administration during the study period.
- •6.Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •7.History of any neurological disorder, meningitis or seizures.
- •8.Axillary temperature >= 38.0°C in past 3 days.
- •9.Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 30 days before the administration of study vaccine or planned use during the study period.
- •10.Planned or elective surgery during the course of the study.
- •11.Toddler with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •12.Toddler with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject.
- •13.The parents or LAR are unwilling or unable to give written informed consent to participate in the study
- •14.Toddlers whose families are planning to leave the area of the study site before the end of the study period.
- •15.Todllers who have participated in another trial or received an investigational agent within 30 days of enrolment.
- •Exclusion criteria for the second dose
- •1.Hypersensitivity to vaccine within 48 hours of administration of previous vaccine dose
- •2.Seizures
- •3.Encephalopathy
- •4.Axillary temperature of > 40oC within 48 hours of previous vaccine dose
- •5.Inconsolable persisting crying (defined as > 3 hours within 48 hours of previous vaccination),
- •6.Generalized cyanosis within 48 hours of previous vaccine dose
- •7.Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial.
研究者
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