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:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05721456
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects, 6-12 weeks of age, inclusive, at the time of the first vaccination.
2. Healthy subjects as established by medical history and clinical examination before entering into the study.
3. Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol, including:
1. willing to provide name, address, and telephone number for contact if necessary (e.g., in case of missing a scheduled visit)
2. available for follow-up throughout the study period
3. capable to complete the forms for registration of signs and symptoms at home.
4. Parent(s)/LAR(s) are able to understand and sign the informed consent form.
Exclusion Criteria:
1. Preterm infants (gestation \<36 weeks) or with low birth weight (\<2000g).
2. Use of any investigational or non-registered product other than the study vaccines and allowed co-administered vaccines as outlined in section 3.4.9. during the entire study period. Any other vaccine administration must be discussed and approved by the medical monitor.
3. Medical history of culture- or PCR-confirmed invasive disease caused by S. pneumoniae.
4. Coagulation problems.
5. Chronic administration (more than 14 days in total) of corticosteroids, immunosuppressants or other immune-modifying drugs (except palivizumab) since birth or planned use during the study.
6. Administration of immunoglobulins and/or blood products since birth or planned use during the study period.
7. Participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
8. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
9. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
10. Major congenital defects or serious chronic illness.
11. History of any seizures or any neurological disease
12. Acute disease and/or fever (axillary temperature ≥38ºC) at the time of enrolment.
13. Previous vaccination with any pneumococcal vaccine.
14. Infants born of woman who received any pneumococcal vaccine during pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
4 Months
Study:
NCT05721456
Study Brief:
Protocol Section:
NCT05721456