Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT03578120
Eligibility Criteria:
Inclusion Criteria:
* Age eligible for routine pre-school booster vaccinations (i.e. from 3 years and 4 months of age)
* Participated in the iMAP2 trial
* Informed consent by a parent or legal guardian
Exclusion Criteria:
* Permanent exclusion criteria:
* Fulfil any of the contraindications to vaccination specified in The Green Book on Immunisation (https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book)
* Received any additional pertussis containing vaccine after the routine 16 week booster
* Previous or concurrent participation in an interventional study other than iMAP2 if, in the opinion of the investigator, this may influence the objectives of this study
* Temporary exclusion criteria:
* If the child has an axillary/aural temperature ≥ 38°C then vaccination and blood sampling will be postponed until resolution of fever. If the child is acutely unwell, vaccination will be postponed until resolution
* If the child is receiving antibiotics (other than long term prophylaxis) vaccination should be postponed until 48 hours after the conclusion of the course
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
4 Years
Study:
NCT03578120
Study Brief:
Protocol Section:
NCT03578120