NL-OMON50356已完成4 期
ong-term memory immunity against Bordetella pertussis in children 9 years of age who have been vaccinated with acellular pertussis vaccines: effect of an extra preadolescent acellular booster vaccination - Pertussis Immunization study
RIVM0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- 年龄范围
- 2 至 11（—）
入选标准
- •Good general health;
- •8-9 years of age;
- •Vaccinated with Infanrix-IPV + Hib (GSK) at 2, 3, 4, and 11 months of age and
- •with Infanrix-IPV (GSK) at 4 years of age;
- •Received all other regular vaccines according to the Dutch NIP;
- •Provision of written informed consent by both parents or legal
- •representatives;
- •Adherent to protocol and available during the study period
排除标准
- •Present evidence of serious disease(s) demanding immunosuppressive medical
- •treatment, like corticosteroids, that might interfere with the results of the
- •study. Treatment within the 3 months before the study (chronic infection,
- •clotting disorder, genetic disorder);
- •Serious infection disease or fever (>38.5°C) within 14 days before the
- •vaccination;
- •Antibiotic use within 14 days before vaccination;
- •Any known primary or secondary immunodeficiency;
- •Previous administration of plasma products (including immunoglobulins) within
- •the last 6 months;
- •Vaccination with any other pertussis vaccine than those described in the
- •inclusion criteria (i.e. vaccinated with Pediacel or Triaxis (both from Sanofi
- •Pasteur MSD));
- •Vaccination other than those used in the NIP within a month before
- •vaccination/ venapuncture;
- •(suspected) Presence of allergy against (one of the) components of het
- •In the past an allergic reactions after vaccination;
- •Neurologic condition (like epilepsy).
研究者
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