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 @ 4:34 AM
Ignite Modification Date:
2025-12-25 @ 4:34 AM
NCT ID:
NCT03489018
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants aged 6-8 weeks of age (HIV positive or negative but with no symptoms of current clinical immunosuppression i.e. HIV infection at WHO clinical stage 1);
* Parents are willing to provide informed consent for their child to participate in the study
* Parents and infant are likely to remain in the study area until the infant is 18 months of age and comply with study requirements including the requirement to return to the same health facility to obtain all other childhood vaccines.
Exclusion Criteria:
* Infants \>8 weeks of age at time of enrolment
* Signs or symptoms of immunosuppression or HIV infection clinical stage 2 or above.
* Acute illness (e.g. febrile disease) on the day of vaccination
* Contraindications precluding vaccination (e.g. hypersensitivity to any component of the vaccine, including diphtheria toxoid)
* Previous PCV vaccination
* Family are planning to migrate out of the study areas before the end of the study follow-up
* Family are planning to obtain the subsequent vaccine doses of the routine immunisation schedule elsewhere and therefore their child may receive a full dose under the routine vaccination programme.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
8 Weeks
Study:
NCT03489018
Study Brief:
Protocol Section:
NCT03489018