CTRI/2015/12/006456已完成2 期
â??A Phase 2, Prospective, Multi-Center, Randomized, Two-Arm, Active Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Serum Institute of Indiaâ??s 10-valent PneumococcalConjugate Vaccine (SIILPCV10) in Healthy Indian PCV-Naïve Toddlers (12 to 15 months)â??
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
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
- •Toddlers will be eligible for enrolment if all of the following apply at the time of screening:
- •They are healthy Indian PCV-naïve toddlers who are 12 to 15 months of age inclusive, at Day 0 (randomization and first vaccination).
- •-Toddler subjects will be eligible from the day they reach 12 months of age until the day before they reach 16 months.
- •-â??Healthyâ?? toddlers are those without acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or hematological functional abnormality or illness that requires medical therapy, as determined by medical history or clinical assessment before entering the study.
- •-PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
- •Toddlers must have a weight-for-age Z score of >=-2 at the time of enrolment (WHO child growth standard).
- •Toddlers with an up-to-date minimal vaccination status for their age at the time of enrolment (â??minimalâ?? defined as single dose of BCG, 3 doses of OPV, DPT, and Hepatitis B, and single dose of Measles at the time of enrolment).
- •Toddlerâ??s parent must provide voluntary written informed consent to have the toddler participate in the study and should be capable of comprehending and complying with study requirements and procedures, and be able and willing to complete subject diary and to return with the toddler for all scheduled follow up visits.
- •Toddlerâ??s parent should have expressed availability with no plans to travel outside the study area for the duration of the study, and have a known place of residence, with access to a consistent means of telephone contact, either residential land line or cellular mobile.
- •Toddlerâ??s parent must be willing to avoid giving herbal or other local traditional medications to the toddler for consumption (ingestion) during the course of the study.
排除标准
- •A Toddler who meets, any of the following criteria at screening will not be eligible for enrolment in the study:
- •Use of any investigational or non-registered medicinal product within 90 days prior to administration of study vaccine or planned use during the duration of the study.
- •History of previous vaccination against Streptococcus pneumoniae or history of suspect Streptococcus pneumoniae infection since birth.
- •History of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation.
- •History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- •History of anaphylactic reaction.
- •Any screening laboratory test result outside normal range and deemed by the PI to be clinically significant. Each such assessment may be repeated once during the screening period, with the most recent laboratory value being used for evaluation of exclusion criteria.
- •Any abnormal vital sign deemed by the PI to be clinically significant. Such an abnormal vital sign may be repeated once during the screening period for the toddler to remain eligible for randomization.
- •Acute illness (moderate or severe) and/or fever (axillary temperature >=37.5°C).
- •Note: Subjects with an acute illness/fever may return once for a repeat screening visit within the 2-week screening period and still qualify for randomization if the acute illness has resolved. A minimum of 72 hours following a documented fever must pass before the subject can be re-screened and vaccinated.
- •Receipt of antibiotics (oral or injected) within 5 days of randomization/vaccination.
- •Evidence by history taking alone (mothers will not be tested routinely) of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other blood-borne mechanisms.
- •HIV and/or HBsAg positive serological tests at the time of screening.
- •Note: HIV seropositivity will result in a subject being excluded from the trial even though this may reflect maternal antibody transfer rather than HIV infection in the toddler. In all such cases, standard follow-up measures would be instituted appropriately.
- •Family history of suspected primary immunodeficiency in first-degree relative.
- •Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine, including the use of glucocorticoids. Short term ( <14 days) administration of topical and inhaled steroids is permitted.
- •Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period.
- •Toddler or any first-degree relative (e.g. parent, siblings) with known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g. thalassemia, coagulation factor deficiencies).
- •History of meningitis or seizures or any neurological disorder.
- •Toddler who has had a sibling die of sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life.
- •Evidence of a clinically signific
研究者
相似试验
进行中（未招募）
不适用
A PHASE II PROSPECTIVE, RANDOMIZED, MULTI-CENTER, DIABETIC MACULAR EDEMA DOSE RANGING, COMPARATOR STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04523655 VERSUS LASER THERAPY (DEGAS)EUCTR2008-000349-68-GBPfizer Inc. 235 East 42nd Street, New York NY10017160
进行中（未招募）
不适用
A PHASE II PROSPECTIVE, RANDOMIZED, MULTI-CENTER, DIABETIC MACULAR EDEMA DOSE RANGING, COMPARATOR STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04523655 VERSUS LASER THERAPY (DEGAS)EUCTR2008-000349-68-DKPfizer Inc. 235 East 42nd Street, New York NY10017160
进行中（未招募）
不适用
A PHASE II PROSPECTIVE, RANDOMIZED, MULTI-CENTER, DIABETIC MACULAR EDEMA DOSE RANGING, COMPARATOR STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04523655 VERSUS LASER THERAPY (DEGAS)Diabetic Macular EdemaMedDRA version: 14.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 100000004853EUCTR2008-000349-68-ITPFIZER160
进行中（未招募）
不适用
A PHASE II PROSPECTIVE, RANDOMIZED, MULTI-CENTER, DIABETIC MACULAR EDEMA DOSE RANGING, COMPARATOR STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04523655 VERSUS LASER THERAPY (DEGAS)Diabetic Macular EdemaMedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edemaEUCTR2008-000349-68-DEPfizer Inc. 235 East 42nd Street, New York NY10017160
进行中（未招募）
不适用
A PHASE 2, PROSPECTIVE, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ACTIVE- CONTROL, PARALLEL-GROUP STUDY TO DETERMINE THE SAFETY OF AND TO SELECT A TREATMENT REGIMEN OF CC-4047 EITHER AS SINGLE-AGENT OR IN COMBINATION WITH PREDNISONE TO STUDY FURTHER IN SUBJECTS WITH MYELOFIBROSIS WITH MYELOID METAPLASIA - NDMYELOFIBROSIS WITH MYELOID METAPLASIAMedDRA version: 9.1Level: LLTClassification code 10028537Term: MyelofibrosisEUCTR2006-004553-17-ITCelgene Corporation80