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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT01200368
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects between 3 to 6 months of age at the enrollment.
* Available for the entire study period and whose parent/legal guardian can be reached by telephone.
* Healthy infant as determined by medical history, physical examination, and judgement of the investigator.
Exclusion Criteria:
* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
* History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
* Infant who is a direct descendant (child, grandchild) of the study site personnel.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
6 Months
Study:
NCT01200368
Study Brief:
Protocol Section:
NCT01200368