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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT04841369
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
* Willing to provide proof of identity;
* Without vaccination history of pneumococcal vaccine;
* None-pregnancy or do not plan to pregnancy recently;;
* Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
* Volunteers of 8-17 years old and their guardians who willing sign informed consent;
* Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
* Able and willing comply with the requirements of the protocol
Exclusion Criteria:
* Volunteers whose axillary body temperature was \>37.0# before vaccination
* Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
* Volunteers who has a history of epilepsy, convulsions or psychosis;
* Allergic person;
* Any prior administration of blood products in last 3 month;
* Any prior administration of other research medicines in last 1 month;
* Plans to participate in or is participating in any other drug clinical study;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Had fever before vaccination, Volunteers with temperature \>37.0°C on axillary setting;
* According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Study:
NCT04841369
Study Brief:
Protocol Section:
NCT04841369