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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07446166
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to provide informed consent to take part in the study; either directly or from a parent/guardian, where appropriate
* \[Group A\] Aged 5-10 years inclusive, and determined as healthy by a member of the study team
* \[Group B\] Aged 18-25yrs inclusive, and determined as healthy by a member of the study team
* \[Group C\] Currently pregnant at any stage of pregnancy, prior to receipt of a tetanus booster vaccine in pregnancy, and determined as healthy by a member of the study team and safe to provide a blood sample
* \[Group D\] Adults aged 18-45 years with one or more of the medical conditions that may affect antibody response to vaccination.
Exclusion Criteria:
* Participants or parents/guardians unwilling or unable to provide informed consent to take part
* Unwilling or unable to comply with study procedures
* Have a bleeding disorder deemed significant by study doctor
* \[Groups A, B and C only\] Any health condition which, in the opinion of a study physician which could
1. mean blood sampling has the potential for harm and/or
2. affect immune response to a vaccine for example known/suspected impairment of immune function (with the exception of Group D)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
45 Years
Study:
NCT07446166
Study Brief:
Protocol Section:
NCT07446166