Neonatal Pneumonia, Sepsis, and Meningitis
Conditions
Interventions
Placebo group (single-dose regimen group):Administer one dose of Sodium Chloride Injection, 0.5 ml, according to the immunization schedule on day 0.
Test group (two-dose regimen group):Administer two doses of the 6-valent Group B Streptococcus conjugate vaccine, 0.5 ml/dose, according to the immunization schedule at months 0 and 1.
Calibration group:Administer two doses of the 6-valent Group B Streptococcus conjugate vaccine, 0.5 ml/dose, according to the immunization schedule at months 0 and 1.
Test group (single-dose regimen group):Administer one dose of the 6-valent Group B Streptococcus conjugate vaccine, 0.5 ml, according to the immunization schedule on day 0.
Placebo group (two-dose regimen group):Administer two doses of Sodium Chloride Injection, 0.5 ml/dose, according to the immunization schedule at months 0 and 1.
Sponsors
Hubei Provincial Center for Disease Prevention and Control.
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1.Healthy individuals aged 18–49; 2.The volunteer, after being fully informed and providing consent, voluntarily signs the informed consent form, agrees to provide identification documents, and is able to comply with the requirements of the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1.Axillary temperature >= 37.3 °C before vaccination; 2.History of invasive Group B streptococcal disease; 3.Clinically significant abnormalities in blood routine, blood biochemistry, coagulation function, or urinalysis as determined by the investigator; 4.Positive urine pregnancy test for women of childbearing potential, currently breastfeeding, or planning pregnancy within 12 months after enrollment; male participants planning for pregnancy within 12 months after enrollment; 5.Hypertension (systolic blood pressure >=140 mmHg, diastolic blood pressure >=90 mmHg); 6.Severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc.; 7.History or family history of epilepsy, convulsions, cerebral palsy, or psychiatric disorders; 8.Long-term systemic corticosteroid therapy (>=2 weeks, dose >=2 mg/kg/day or >=20 mg/day prednisone or equivalent) within 3 months before vaccination or planned during the trial; topical use (ointments, eye drops, inhalers, or nasal sprays) is permitted; 9.Use of blood products or immunoglobulins within 3 months before enrollment or planned during the trial (use of hepatitis B immunoglobulin or autologous transfusion is acceptable); 10.Diagnosed congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, juvenile rheumatoid arthritis, or other autoimmune diseases; 11.Asplenia or splenic dysfunction due to any cause; 12.Known or suspected serious chronic diseases, including severe respiratory, cardiovascular, hepatic, renal, or dermatological diseases, malignancies, uncontrolled diabetes and its complications, etc.; 13.Acute illness within 3 days before vaccination, acute exacerbation of chronic diseases, or use of antipyretics, analgesics, antihistamines (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) or antibiotics; 14.History of coagulation disorders (e.g., coagulation factor deficiency, coagulopathy) or bleeding tendency (significant bleeding, hematoma, or bruising after previous intramuscular injection or venipuncture); 15.History of severe allergic reactions, e.g., anaphylactic shock, allergic angioedema, allergic purpura, thrombocytopenic purpura, Arthus reaction, dyspnea, angioneurotic edema, etc.; 16.Allergy to diphtheria or tetanus toxoid-containing vaccines and Group B streptococcal vaccines; 17.Receipt of live attenuated vaccines within 28 days before enrollment or other vaccines within 14 days before enrollment; 18.Participation in other clinical trials within 3 months before enrollment or planned during the study; 19.Plans to relocate or be away from the local area for an extended period during scheduled trial visits before the trial ends; 20.Any condition considered by the investigator as potentially interfering with the evaluation of the trial objectives. 21.In addition to the general exclusion criteria, participants assigned to the calibration group must also not meet the following exclusion criteria:1)Weight 50 U/L; or hemoglobin < 115 g/L (female) / 120 g/L (male);3)A final positive result in any of the following infection marker tests: hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis;4)History of blood donation within 6 months prior to enrollment. 22.Exclusion Criteria for Subsequent Doses:1)Occurrence of a severe allergic reaction following the previous vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood count;AESI ?SAE;MAAE;adverse events/reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titers (GMT) and geometric mean fold rises (GMFR) of six specific Group B Streptococcus OPA antibodies, as well as geometric mean concentrations (GMC) and GMFR of IgG antibodies.; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Prevention and Control.
Outcome results
None listed