Memory response against Bordetella pertussis in adults: immunological effects of an acellular pertussis booster vaccinatio

Phase 1

• Conditions: The vaccine administered in this study is used to prevent pertussis caused by the bacterium Bordetella pertussis; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2013-005355-32-NL
• Lead Sponsor: ational Institute for Public Health and the Environment (RIVM, the Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-24
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, participants must meet all of the following criteria:
• Good general health;
• 25-29 years of age;
• Vaccinated with DTwP-IPV (RIVM) at 3, 4, 5, and 11 months of age;
• Received all other regular vaccines according to the Dutch NIP;
• Provision of written informed consent;
• Adherent to protocol and available during the study period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the following criteria will exclude a participant from this study:
• Antibiotic use within 14 days of enrollment;
• 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;
• Known or suspected allergy to any of the vaccine components (by medical history);
• Occurrence of serious adverse event after primary DTwP-IPV vaccination or other vaccination (by medical history);
• 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/ saliva sampling;
• Vaccination with any other pertussis vaccine than those described in the inclusion criteria;
• No DT or DT-IPV vaccination at least 5 years before enrollment;
• Vaccination within a month before enrollment;
• Pregnant at start of study (when vaccination is administered);

Study & Design

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