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

Phase 1

• Conditions: Pertussis infection; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-003678-42-NL
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

•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

Exclusion Criteria

•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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified