Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months (P13UK)
A Prospective Study to Evaluate the Immune Response of UK Infants Receiving the 13-valent Pneumococcal Conjugate Vaccine as Part of Their Routine Primary Immunisation Schedule at 2 and 4 Months
研究概览
地位
条件
详细说明
This study will aim to prospectively recruit infants in the first 6 months of life who are either due to receive or in the process of receiving their routine infant immunisation and request one blood sample one month after completing their primary immunisation schedule, which will be at around 5 months of age, if they fulfil the inclusion criteria for the study.
NUMBER OF SUBJECTS AND DURATION OF STUDY
A total of 200 infants will be recruited in two centres - Hertfordshire and Gloucestershire.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Hertfordshire And Gloucstershire、英国
- Multiple GP surgeries
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Male or female infants born at term (at least 37 weeks gestation) aged <6 months:
- With written informed consent obtained from the parent or legal guardian of the infant to participate in the study and to allow the infant's General Practitioner (GP) to be informed of participation in the study and be contacted, if required, for confirmation of the vaccination history
Who have received all their primary immunisations in the 1st 6 months of life, including:
- 3 doses of Pediacel®
- 2 doses of Prevenar13®, with the 1st dose given at 6-12 weeks of age and the 2nd dose at 8-12 weeks after the 1st dose
- 2 doses of any MenC vaccine
- Do not fulfil any of the Exclusion Criteria
Exclusion Criteria:
Participant may not be included in the study if any of the following apply:
- History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
- Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
- Bleeding disorders and/or prolonged bleeding time
- Major congenital defects or chronic disease
- Premature birth (<37 weeks gestation at birth)
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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1. To determine the proportion of infants with pneumococcal serotype-specific IgG antibody concentrations ≥0.35 μg/ml for the 13 serotypes included in Prevenar13 at one month after completion of primary immunisation
大体时间:24 months
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24 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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1. To determine the geometric mean concentrations (GMCs) of pneumococcal serotype-specific IgG antibody concentrations for each of the 13 serotypes in Prevenar13 one month after primary immunisation
大体时间:24 months
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24 months
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2. To determine, using a functional opsonophagocytic assay (OPA), the proportion of infants with geometric mean titres (GMT) ≥1:8 for the 13 serotypes in Prevenar13 one month after primary immunisation
大体时间:24 months
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24 months
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3. To determine serum bactericidal assay (SBA) titres with 95%CI for MenC and the proportion of infants achieving SBA titres ≥8 or ≥128 one month after primary immunisation
大体时间:24 months
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24 months
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4. To determine Hib GMC with 95%CI and proportions of infants with Hib antibody concentrations ≥0.15 μg/ml or ≥1.0 μg/ml one month after primary immunisation
大体时间:24 months
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24 months
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合作者和调查者
调查人员
- 学习椅:Elizabeth Coates, PhD、Public Health England
出版物和有用的链接
一般刊物
- Andrews NJ, Waight PA, Burbidge P, Pearce E, Roalfe L, Zancolli M, Slack M, Ladhani SN, Miller E, Goldblatt D. Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study. Lancet Infect Dis. 2014 Sep;14(9):839-46. doi: 10.1016/S1473-3099(14)70822-9. Epub 2014 Jul 17.
- Ladhani SN, Andrews NJ, Waight P, Hallis B, Matheson M, England A, Findlow H, Bai X, Borrow R, Burbidge P, Pearce E, Goldblatt D, Miller E. Interchangeability of meningococcal group C conjugate vaccines with different carrier proteins in the United Kingdom infant immunisation schedule. Vaccine. 2015 Jan 29;33(5):648-55. doi: 10.1016/j.vaccine.2014.12.018. Epub 2014 Dec 12.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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