A study exploring whooping cough protection in children and adults

Phase 1

• Conditions: This study is going to focus on the immunisation against pertussis disease in previous healthy participants (adults and children), but the disease itself is not going to be studied.; MedDRA version: 20.0Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10047976Term: Whooping cough due to bordetella pertussis (B. pertussis)System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-003678-42-GB
• Lead Sponsor: CTRG, University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-08
• Last Update Posted: 14 December 2020

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
• Provision of written informed consent
• 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 and/or suspected allergy to any of the vaccine components (by medical history);
• Occurrence of a 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 other 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, a DT-IPV vaccination according to NIP in cohort B is not an exclusion criterion;
• 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 Dutch NIP around 9 years of age;
• Mixed wP and aP priming within a participant, cohort B;
• Pregnancy.

Study & Design

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