Pertussis, diphtheria, tetanus, Haemophilus influenzae type b disease
Conditions
Sponsors
Yunnan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Healthy adults aged 18 and above, children aged 3-6, or infants aged 3 months and above with legally recognized identification. 2)Participants voluntarily agree to participate, or legal guardians or authorized representatives voluntarily consent to their children's participation, having understood and signed the informed consent form. 3)Participants/legal guardians or authorized representatives have the ability to comply with the requirements of the clinical trial protocol and complete trial visits. 4)For participants aged 3 months: not vaccinated with any pertussis vaccines, Hib vaccines, or combination vaccines containing pertussis/Hib components. For participants aged 3-6: completed the full course of pertussis vaccination (4 doses) according to the immunization schedule, not received pertussis vaccine, Hib vaccine, or combination vaccine containing pertussis/Hib components in the 6-year immunization plan, with an interval of >12 months from the most recent pertussis combination vaccine. For participants aged 18 and above: an interval of >3 years from the most recent pertussis vaccine, Hib vaccine, or combination vaccine containing pertussis/Hib components. 5)*An interval of =14 days from the most recent live attenuated vaccine and =7 days from other subunit or inactivated vaccines. 6)Female participants of childbearing age should not be pregnant or lactating, have a negative pregnancy test before vaccination (menstrual cessation for at least 1 year or surgical sterilization exempts from pregnancy test), and have taken effective contraceptive measures in the 2 weeks before the trial selection. Female participants of childbearing age from the trial selection until 180 days after vaccination and male participants aged 18 and above from the trial selection until 30 days after vaccination should have no plans for pregnancy and agree to use effective contraception during the trial. Effective contraceptive measures include oral contraceptives (excluding emergency contraceptives), injectable or implanted contraceptives, slow-release local contraceptives, hormone patches, intrauterine devices, sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. 7)No axillary temperature =38.0? in the past 3 days, and axillary temperature on the day of enrollment <37.3?. If the participant does not meet the criteria with a star (), visits can be rescheduled when the criteria are met.
Exclusion criteria
Exclusion criteria: First Dose Exclusion Criteria: Participants meeting any of the following conditions cannot be included in the trial: 1) Participants aged 3 months who are premature infants (born before 37 weeks of gestation), or have low birth weight (girls <2300g, boys <2500g), or macrosomic infants (birth weight =4000g). 2) Participants aged 3 months with congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc. 3) Participants aged 3 months with a history of abnormal delivery (dystocia, instrumental delivery), resuscitation due to asphyxia, or history of neural organ damage. 4) Participants aged 3 months diagnosed with pathological jaundice or a history of pathological jaundice (lasting 2-4 weeks, recurring). 5) *Participants aged 18 and above with uncontrolled hypertension or, during screening, blood pressure measurements: systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg. 6) Abnormal results in pre-vaccination complete blood count, liver function, and kidney function tests, as judged by the investigator and clinically significant. 7) Known allergy to any component of the vaccine used in this clinical trial (including acellular pertussis vaccine, diphtheria and tetanus toxoids, Haemophilus influenzae type b capsular polysaccharide conjugated to tetanus toxoid, and 3-(N-morpholino) propane sulfonic acid). 8) History of severe vaccine or drug allergies (e.g., anaphylactic shock, angioedema, allergic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction), etc.). 9) History of seizures, epilepsy, cerebral diseases, or a family history of these conditions. 10) Diagnosed history of decreased platelets or other coagulation disorders. 11) *Acute illness or acute exacerbation of chronic illness within the past 3 days before vaccination. 12) *Use of drugs containing antipyretic or antiallergic components in the 3 days before vaccination (such as acetaminophen, ibuprofen, aspirin, loratadine, etc.). 13) Known or suspected immunodeficiency (e.g., human immunodeficiency virus (HIV) infection, history of thyroid, pancreatic, hepatic, splenic, or renal disease, or removal). 14) *Within the past 6 months (interval <6 months) or planning to undergo immunomodulatory therapy (including chemotherapy) during the trial, such as prolonged systemic glucocorticoid therapy (continuous use for 2 weeks or more at a dose =2mg/kg/day or =20mg/day prednisone or equivalent to prednisone; local use is allowed (such as ointment, eye drops, inhalers, or nasal sprays, local use should not exceed the recommended dose in the instructions)), thymopeptide, interleukin, interferon, agaricus polysaccharide, BCG-PSN, etc. 15) Current or past history of pertussis, diphtheria, tetanus, or Hib infection (including meningitis, pneumonia, sepsis, cellulitis, arthritis, epiglottitis, etc.). 16) Known or suspected severe diseases such as Down syndrome, uncontrolled diabetes, cardiovascular diseases (heart disease, pulmonary heart disease, heart failure, etc.), severe thalassemia, sickle cell anemia or neurological disorders, Guillain-Barré syndrome, etc., severe respiratory diseases, liver or kidney diseases, malignant tumors, severe infectious or hypersensitivity skin diseases. 17) *Receipt of blood products and immunoglobulins within the past 3 months (<3 months) (use of hepatitis B immunoglobulin is acceptable). 18) Currently participating in or planning to participate in other clinical trials during this
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Anti-diphtheria toxoid (DT);Anti-tetanus toxoid (TT);Anti-pertussis toxin (PT);Anti-filament hemagglutinin (FHA) antibody titers;Anti-filament hemagglutinin (FHA) antibody titers;Complete Blood Count;Liver Function Tests;Kidney Function Tests; | — |
Countries
China
Contacts
Public ContactYan Zheng
Yunnan Provincial Center for Disease Control and Prevention
Outcome results
None listed