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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02943902
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent by the parent/guardian of the child;
2. Born to an HIV-uninfected women, based on testing undertaken as part of standard of care during the last trimester of pregnancy;
3. Had not received any vaccine other than BCG and OPV (routinely given at birth) prior to enrolment;
4. Birth weight \>2499g AND weight of child \>3.5 kg at time of proposed randomization;
5. Aged 42-56 days of age at time of enrolment;
6. Available for the duration of the study;
7. Child is healthy based on medical history and physical examination of the study-staff.
Exclusion Criteria:
1. Any clinically significant major congenital abnormalities;
2. Previous hospitalization for a respiratory illness following discharge from hospital after birth;
3. Receipt of any other investigational drug/vaccine. Co-enrollment into non-investigational studies, including epidemiology studies, is allowed;
4. Any previous PCV vaccination;
5. Known allergy to any of the vaccine components;
6. Febrile illness (axillary temperature ≥37.8°C) at time of enrolment. These participants are eligible if the temperature resolves for at least 48 hours and they remain within the study defined window periods;
7. Planned relocation to outside of the study area during up until age of 2 years;
8. Receipt of blood transfusion or any other blood products (including immunoglobulins) since birth. Receipt of such products during the course of the study, will require withdrawal of the child from the study;
9. History of confirmed pneumococcal disease since birth;
10. Any known or suspected immunodeficiency condition which could affect immune response to vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Weeks
Maximum Age:
18 Months
Study:
NCT02943902
Study Brief:
Protocol Section:
NCT02943902