Additional Measles Vaccine at 4 Months of Age
A Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality and to Explore the Role of Maternal Measles Antibodies for the Beneficial Non-specific Effects of Measles Vaccine
Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months.
Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls.
Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb.
Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.
調査の概要
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Bissau、ギニアビサウ、1004
- 募集
- Bandim Health Project
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主任研究者：
- Cesario L Martins, MD, PhD
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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
説明
Inclusion Criteria:
- Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier
Exclusion Criteria:
- Malformations
- Severely ill
- Severely malnourished
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
- 主な目的：防止
- 割り当て：ランダム化
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Early measles vaccine
Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age
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Edmonston-Zagreb measles vaccine
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介入なし：No early measles vaccine
Receives only the standard measles vaccine at 9 months of age
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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 |
メジャーの説明 |
|---|---|
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Mortality
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Differences in mortality rates between the intervention and control groups
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二次結果の測定
結果測定 |
メジャーの説明 |
|---|---|
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Morbidity
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Symptoms of infection
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Hospitalisations/consultations
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Visits to health center for consultation due to illness, hospitalisation
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Growth
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Weight, length, arm circumference
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Measles infection
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Measles infection assessed by medical doctor and/or verified by blood samples
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
- Nielsen S, Fisker AB, da Silva I, Byberg S, Biering-Sorensen S, Bale C, Barbosa A, Bjerregaard-Andersen M, Hansen NS, Do VA, Baek O, Rasmussen SM, Damkjaer L, Hvidt S, Baltzersen O, Rodrigues A, Martins C, Jensen KJ, Whittle HC, Smits G, van der Klis F, Aaby P, Benn CS. Effect of early two-dose measles vaccination on childhood mortality and modification by maternal measles antibody in Guinea-Bissau, West Africa: A single-centre open-label randomised controlled trial. EClinicalMedicine. 2022 May 27;49:101467. doi: 10.1016/j.eclinm.2022.101467. eCollection 2022 Jul.
- Hansen NS, Byberg S, Hervig Jacobsen L, Bjerregaard-Andersen M, Jensen AKG, Martins C, Aaby P, Skov Jensen J, Benn CS, Whittle H. Effect of early measles vaccine on pneumococcal colonization: A randomized trial from Guinea-Bissau. PLoS One. 2017 May 17;12(5):e0177547. doi: 10.1371/journal.pone.0177547. eCollection 2017. Erratum In: PLoS One. 2019 Oct 30;14(10):e0224782.
- Christensen LD, Eriksen HB, Biering-Sorensen S, Bale C, Do VA, Andersen A, Martins CL, Sodemann M, Aaby P, Benn CS. The effect of early measles vaccination on thymic size. A randomized study from Guinea-Bissau. Vaccine. 2014 Mar 26;32(15):1641-4. doi: 10.1016/j.vaccine.2014.01.034. Epub 2014 Feb 9.
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- MVurban
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