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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06314867
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers aged 18-59;
* Voluntarily participate and sign an informed consent form;
* Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;
* Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);
* Underarm temperature ≤ 37.0 ℃;
* Female participants of childbearing age agree to take effective contraceptive measures within 3 months from the start of the study until the full vaccination period.
Exclusion Criteria:
* Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;
* Has a history of severe allergies to any drugs or vaccines in the past;
* Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);
* Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;
* Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;
* Subjects with known immunological dysfunction or low levels, or HIV infection;
* Any situation leading to splenomegaly, splenectomy, or functional splenomegaly;
* Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period;
* Anti tuberculosis prevention or treatment is under way;
* Subjects who are participating in or planning to participate in clinical trials of other drugs or vaccine clinical trials throughout the entire observation period;
* Women of childbearing age are in pregnancy (positive urine pregnancy test) or lactation period;
* Any situation that the researcher believes may affect the evaluation of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT06314867
Study Brief:
Protocol Section:
NCT06314867