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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT02119104
Eligibility Criteria:
Inclusion Criteria:
* Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
* Infants aged 2 months, inclusive, to 7 months, exclusive
* Infants with no history of administration of pneumococcal vaccines including Prevenar 13
* Infants expected to receive 4 vaccinations
Exclusion Criteria:
* Vaccines must not be performed if the vaccinee corresponds to any of the following:
* Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
* Persons with evident pyrexia
* Persons who evidently have serious acute diseases
* Besides the persons listed above, persons who are in a status inappropriate for immunization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
6 Months
Study:
NCT02119104
Study Brief:
Protocol Section:
NCT02119104