Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.<br>An international study in Finland, the Netherlands and the United Kingdom
- Conditions
- 10004018PertussisWhoping Cough
- Registration Number
- NL-OMON45409
- Lead Sponsor
- RIVM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 134
* normal general health;
* within the right age group for the cohort;
* received all regular vaccines for their age group according to the Dutch National immunisation programme (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 / General practitioner. 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.
* 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 (Diphtheria, Tetanus, whole-cell Pertussis, Polio) vaccination, DTaP-IPV (Diphtheria, Tetanus, acellular Pertussis, Polio) 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 Diphtheria, Tetanus and polio (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 DT-IPV booster vaccination according to the Dutch NIP around 9 years of age;
* mixed whole-cell pertussis (wP) and acellular pertussis (aP) priming within a participant, cohort B;
* Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PT specific IgG antibodies at day 28 (T4). </p><br>
- Secondary Outcome Measures
Name Time Method