Invasive infection caused by Haemophilus influenzae type B (including meningitis, pneumonia, septicemia, cellulitis, arthritis, epiglottis, etc.)
Conditions
Interventions
Control group 1:Four doses of control vaccine (0,1,2 procedure, one dose at the age of 18 months)
Control group 2:Three doses of control vaccine (0,1 procedure, one dose at the age of 18 months)
Control group 3:One dose of control vaccine
Experimental group 1:Four doses of experimental vaccine (0,1,2 procedure, one dose at the age of 18 months)
Experimental group 2:Three doses of experimental vaccine (0,1 procedure, one dose at the age of 18 months)
Experimental group 3:One dose of experimental vaccine
Pre experiment group 1:One dose of experimental vaccine
Pre experiment group 2:One dose of experimental vaccine
Pre experiment group 3:One dose of experimental vaccine
Pre experiment group 4:Three doses of experimental vaccine (0,1 program, one dose for 18 months)
Pre experiment group 5:Four doses of experimental vaccine (0,1,2 procedure, one dose at the age of 18 months)
Sponsors
Hebei Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Basic immune stage: (1) People aged 2 months and above, including 18 years and above and 6-17 years old, are limited to pretest; (2) 2-11 month old infants should be full-term (37-42 weeks of gestation) and the birth weight should reach the standard (weight 2500g to 4000g); (3) Women of childbearing age were not pregnant (negative urine pregnancy test), were not breastfeeding and had no birth plan within the first month after selection; (4) Axillary temperature <=37.0 degree C; (5) I / the legal guardian voluntarily participate and sign the informed consent; (6) According to the opinion of the investigator, the subject and / or the legal guardian of the subject can comply with the requirements of the clinical trial scheme; (7) 2-11 months old has not been vaccinated with any unit price or combined with Haemophilus influenzae B vaccine, 1-5 years old has not been immunized with any unit price or combined with Haemophilus influenzae B vaccine. Strengthening immunity stage: (1) At the age of 2-5 months and 6-11 months, infants and young children who were enrolled in the clinical trial and now aged 18 months were enrolled; (2) Those who have completed basic immunization in this clinical trial; (3) According to the opinion of the investigator, the legal guardian of the subject can comply with the requirements of the clinical trial scheme.
Exclusion criteria
Exclusion criteria: Basic immune stage: (1) Have a history of serious allergic reactions requiring medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock); have a history of allergy to vaccines or vaccine ingredients or other serious adverse reactions to vaccines; (2) Definite diagnosis of thrombocytopenia or other coagulation disorders may lead to the contraindication of intramuscular injection; (3) Abnormal birth process, asphyxia rescue history, or congenital malformations, developmental disorders or serious chronic diseases; (4) Severe cardiovascular, hepatorenal and other diseases, hypertension (systolic blood pressure >=140mmHg and / or diastolic blood pressure >=90mmHg, applicable to the group aged 18 years and over in the pre test stage), or congenital abnormality and HIV infection or parents with HIV infection; (5) Congenital or acquired immune deficiency, and receiving immunosuppressant treatment after birth or within the last 3 months, such as long-term application of systemic glucocorticoid treatment (systemic glucocorticoid treatment, such as prednisone or similar drugs, has been applied for more than 2 weeks); (6) Patients with encephalopathy, epilepsy, convulsion and other progressive nervous system diseases; (7) The subjects had acute disease, severe chronic disease or were in the acute phase of chronic disease; (8) Plans to participate or is participating in any other drug clinical study; (9) Immunoglobulin and / or any blood products were given within 3 months before admission; (10) According to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial. Strengthening immunity stage: (1) After the completion of basic immunization, the subjects were inoculated with any monovalent or combined Haemophilus influenzae type B combined vaccine before blood sampling; (2) After participating in this clinical trial, the subjects have been known or suspected to have immunologic functional defects, including being treated with immunosuppressive drugs (such as radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxic drugs, etc.) and HIV infection; (3) Immunoglobulins and / or any blood products were given within 3 months before the enhancement of immunity; (4) According to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactMa Jingchen
Hebei Center for Disease Control and Prevention
Outcome results
None listed