CTRI/2017/11/010387已完成2 期
An open label parallel randomised Phase-II comparative study to evaluate safety, tolerability and immunogenicity of two intramuscular doses of 14-valent pneumococcal polysaccharide conjugate vaccine administered 2 months apart to 12-23 month-old healthy Indian PCV-naïve toddlers. - 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.Subjectsâ?? 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 PCV-naïve child (toddler) between and including 12 and 23 months of age at the time of first dose vaccination. PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
- •4.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).
- •5.Healthy subjects as established by medical history and clinical examination before entering into the study.
- •6.Subjects that are negative for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C to the best of parent(s)/LAR(s) knowledge
排除标准
- •1.Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
- •2.Previous history of pneumococcal vaccination;
- •3.Evidence of previous or intercurrent Streptococcus pneumoniae infection.
- •4.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.
- •5. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •6.Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ï?³ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •7.Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- •8.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •9.Family history of congenital or hereditary immunodeficiency.
- •10.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.
- •11.Major congenital defects as judged by the PI.
- •12.History of any neurological disorders, meningitis or seizures.
- •13.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.
- •14.Toddler is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel).
- •15.Acute disease and/or fever at the time of vaccination.
- •o Fever is defined as the endogenous elevation of at least one measured body temperature of >= 38â?¦C (>= 100.4â?¦F).8
- •16.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
- •17.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.
- •18. Administration of long-acting immune-modifying drugs at any time during the study period.
- •19. Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- •- collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination,
- •- convulsions with or
研究者
相似试验
进行中（未招募）
1 期
A Study of LY3209590 in Participants With Type 1 DiabetesMedDRA version: 21.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 1EUCTR2019-003589-41-DEEli Lilly and Company238
进行中（未招募）
1 期
A Study of LY3209590 in Participants With Type 1 DiabetesDiabetes Mellitus, Type 1EUCTR2019-003589-41-ESilly S.A.357
已完成
2 期
Clinical trial on effectiveness of SIDDHAR YOGAM THERAPY and Siddha Kalpa Medicine Vilampazha karpam [Internal] in the management of â??Vatha Pitham [Systemic Hypertension]CTRI/2019/06/019956Joshi40
进行中（未招募）
1 期
Compare safety and efficacy of BIBF 1120 versus sunitinibEUCTR2009-009516-44-GBBoehringer Ingelheim Limited100
进行中（未招募）
1 期
A randomised, open label, parallel group Phase II study comparing theefficacy and tolerability of BIBF 1120 versus sunitinib in previouslyuntreated patients with Renal Cell Cancer. - BIBF 1120 in 1st line Renal Cell CarcinomaAdvanced unresectable or metastatic Renal Cell Cancer in patients who have received no previous systemic anticancertreatment.MedDRA version: 12.0Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2009-009516-44-HUBoehringer Ingelheim RCV GmbH & Co KG100