CTRI/2010/091/001125已完成1 期
A PHASE I/II (PILOT) RANDOMIZED SINGLE BLIND TRIAL TO COMPARE THE SAFETY AND IMMUNOGENECITY OF TETRABHAY DTwP-H COMBINATION VACCINE WITH SHANTETRA TM IN HEALTHY CHILDRE
Human Biologicals Institute Indian Immunologicals Limited0 个研究点目标入组 33 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
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
- •?Healthy children between 1 to 5 year of age
- •?Mothers of the enrolled child to be serologically negative for HBsAg
- •?Born after a normal gestational period (36 ? 42 weeks) with a birth weight ≥ 2.5 kg
- •?Judged to be in good health on the basis of reported medical history and history-directed physical examination.
- •?Plans to remain in the study area for the length of the trial.
- •?Legally acceptable representative has provided Informed consent as per ICH ?GCP guidelines.
排除标准
- •?Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- •?Planned participation in another clinical trial during the present trial period
- •?Infant born to known HIV I&II seropositive mother (documented laboratory result of HIV assay from the maternal blood sample is available).
- •?Previous evidence of infection with Diphtheria, Tetanus ,Pertussis and hepatitis B
- •?History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics
- •?Children having any intercurrent illness
- •?Evidence of evolving neurological signs and symptoms.
- •?Known or suspected primary or acquired disease of the immune system.
- •?Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (participants who are taking topical and inhaled steroids could be included in the study as would participants on a ?short course? of oral steroids, <7 days, as long as there are not two courses within the previous two weeks prior to vaccination).
- •?Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
- •?Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures.
- •?Receipt of blood products or immunoglobulin by mother in any trimester or infant since birth.
- •?Daily use of non-steroidal anti-inflammatory drugs.
- •?Receipt of any vaccine other than OPV, BCG and or investigational product within the 30 days prior to enrollment, or planning to receive any other vaccine within 28 days after receiving study vaccine.
- •?Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (eg. wheezing, shortness of breath).
- •?Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- •?History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis and Hepatitis B vaccine in a sibling.
- •?Thrombocytopenia or bleeding disorder that would pose a contraindication to an IM vaccination.
研究者
相似试验
进行中（未招募）
1 期
A Clinical Study in Patients with Small Cell Lung CancerExtensive Disease Small Cell Lung CancerMedDRA version: 16.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003174-83-GBEli Lilly and Company26
进行中（未招募）
1 期
CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FISH OIL-BASED INTRAVENOUS LIPID EMULSIONS IN HOSPITALIZED ADULT PATIENTS TREATED WITH TOTAL PARENTERAL NUTRITION WITH HIGH TRIGLYCERIDES IN BLOODEUCTR2018-002715-10-ESElisabet Leiva Badosa. Phamacy Department. Hospital Universitari de Bellvitge30
尚未招募
3 期
A comparative study to ascertain efficacy of oral antifungal therapy and laser in fungal nail infection.CTRI/2020/04/024536Dr Prasenjeet Mohanty
招募中
2 期
A Controlled Trial of InteractiVe Exergames in DiabetesACTRN12611001025921The University of Queensland40
尚未招募
1 期
A CLINICAL TRIAL ON THE EFFECTIVENESS OF ERUKKU ELAI OTTRADAM FOR THANDAGA VADHAMCTRI/2019/06/019865Goverment Siddha Medical College