Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.An international study in Finland, the Netherlands and the United Kingdom - Booster against pertussis (Bert)

RIVM0 个研究点目标入组 366 人开始时间: 2018年2月12日最近更新: 2020年4月14日

适应症

试验速览

暂无简介。

•normal general health;
•within the right age group for the cohort;
•received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant’s documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked with regulatory agencies / GP. For cohort D this booklet might not be available due to their age;
•provision of written informed consent (see section 11.2 for details);
•willing to adhere to the protocol and be available during the study period.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 216
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study ;
•chronic infection
•known or suspected immune deficiency;
•history of any neurologic disorder, including epilepsy;
•previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling;
•known or suspected allergy to any of the vaccine components (by medical history);
•occurrence of serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history);
•vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. only according to NIP);
•vaccination with any other DT-IPV vaccine in the last 5 years, DT-IPV vaccination according to NIP in cohort B is no exclusion;
•children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to the Dutch NIP around 9 years of age;
•mixed wP and aP priming within a participant, cohort B;

发起方

RIVM