Pertussis immunization study

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: EUCTR2013-001864-50-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: 2013-05-31
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

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