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 - KIM-study

ational Institute for Public Health and the Environment (RIVM, the Netherlands)0 个研究点目标入组 80 人开始时间: 2013年5月31日最近更新: 2021年4月5日

试验速览

暂无简介。

•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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months;
•Antibiotic use within 14 days of enrollment;
•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/ blood sampling;
•Boostrix Polio® must not be given to people with a known hypersensitivity after a previous injection of diphtheria-, tetanus-, pertussis- or poliomyelitis-vaccines or one of the substances of the vaccines;
•Boostrix Polio® is contraindicated to people who suffered from an encephalopathy without a known cause within 7 days after a former pertussis vaccination;
•Boostrix Polio® must not be administered to people who suffered from a temporary trombocytopathia or people who had neurologic complications (convulsions or hypotonehyporesponsive episodes) after a former administration with a diphtheria or tetanus vaccine.

发起方

ational Institute for Public Health and the Environment (RIVM, the Netherlands)