NCT03384589已完成2 期
A Randomized Controlled Trial to Compare a 1-dose vs. 2-dose Priming Schedule of 13-valent Pneumococcal Conjugate Vaccine in Canadian Infants; a Canadian Immunization Research Network (CIRN) Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Immunogenicity of PCV13 post-booster
研究概览
简要总结
This study is assessing if a reduced dosing schedule (1+1) of the 13-valent pneumococcal conjugate vaccine (PCV13) is non-inferior to the currently used schedule used in most of Canada.The vaccine is currently usually given as 3 doses at 2, 4 and 12 months of age. This study aims to find out if it is possible to achieve the same protection using just 2 doses, at 2 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant born at ≥37 weeks' gestation
- •Age 2 months (+ up to 14 days) at time of first study visit
- •Parent/guardian or legally authorized representative has given informed consent for their child's participation.
排除标准
- •Already received any routine 2-month immunizations
- •Previous laboratory confirmed pneumococcal disease
- •Previous receipt of any pneumococcal vaccine
- •Confirmed or suspected immunodeficiency, including but not limited to:
- •Congenital or acquired asplenia, or splenic dysfunction
- •B-cell (humoral), T-cell mediated, complement, or phagocytic function deficiency
- •HIV infection
- •Hematopoietic stem cell transplant (recipient)
- •Malignant neoplasms, including leukemia and lymphoma
- •Nephrotic syndrome
- •Solid organ or islet transplant (candidate or recipient)
- •A family history of congenital or hereditary immunodeficiency
- •Use of systemic immunosuppressive medication, including long-term corticosteroids, chemotherapy, radiation therapy, post-organ transplant therapy, intravenous immunoglobulin and/or specific monoclonal antibody therapy
- •Bleeding disorder or thrombocytopenia, that contraindicates intramuscular (IM) injection and/or blood collection or taking any anti-platelet or anti-coagulant medications
- •Any contraindication to vaccination as per the NACI Canadian Immunization Guide (https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html, accessed 16 September 2017). Note these factors will be considered an exclusion if known at the time of trial enrollment, but specific screening and/or testing for these conditions will not be part of the trial):
- •Anaphylaxis to any vaccine or vaccine component being given during the trial, including PCV13 and other routine vaccines
- •Any other previous adverse event which in the opinion of the Investigator is a contraindication to any vaccine being given during the trial
- •Congenital malformation of the gastrointestinal tract or previous intussusception (rotavirus vaccine contraindicated)
- •Active, untreated tuberculosis (MMR, varicella, MMRV contraindicated)
- •Additional factors resulting in increased risk of pneumococcal disease as per the National Advisory Committee on Immunization (NACI) Canadian Immunization Guide (16 September 2017)
- •Chronic cerebrospinal fluid (CSF) leak
- •Chronic neurologic condition that may impair clearance of oral secretions
- •Cochlear implants, including children who are due to receive implants
- •Chronic heart disease
- •Diabetes mellitus
- •Chronic kidney disease
- •Chronic liver disease, including hepatic cirrhosis due to any cause
- •Chronic lung disease
- •Sickle cell disease or other hemoglobinopathy
- •Mother received pneumococcal vaccine during pregnancy
- •Mother using systemic immunosuppressive medication during pregnancy, including intravenous immunoglobulin and/or specific monoclonal antibody therapy
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •Temporary exclusion criteria:
- •- If an infant has a temperature ≥ 38°C, then vaccination (and blood and fecal sampling if due to occur at the same visit) will be postponed until resolution of fever.
研究组 & 干预措施
Group 2: 2 doses of PCV13
Experimental
PCV13, 0.5ml intramuscular at 2 and 12 months of age
干预措施: PCV13 (Biological)
Group 1: 3 doses of PCV13
Active Comparator
PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age
干预措施: PCV13 (Biological)
结局指标
主要结局
Immunogenicity of PCV13 post-booster
时间窗: 13 months of age
Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose
次要结局
- Immunogenicity of PCV13 post-priming(5 months of age)
- Proportion of protected infants post-priming(5 months of age)
- Proportion of protected infants post-booster(13 months of age)
- Incidence of adverse events following PCV13(2, 4 and 12 months of age)
研究者
Manish Sadarangani
Principle Investigator
University of British Columbia
研究点 (1)
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