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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Hertfordshire And Gloucstershire、イギリス
- Multiple GP surgeries
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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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
時間枠:24 months
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24 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
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
時間枠: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
時間枠: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
時間枠:24 months
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24 months
|
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
時間枠:24 months
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24 months
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Elizabeth Coates, PhD、Public Health England
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- P13UK
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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