Four infectious/infectious diseases: pertussis, diphtheria, tetanus and poliomyelitis
Conditions
Interventions
test group:Adsorbed acellular diphtheria inactivated poliomyelitis combined vaccine
control group:Adsorbed acellular DPT combined vaccine+Sabin strain inactivated polio vaccine (Vero cells)
control group:Adsorbed acellular diphtheria inactivated poliomyelitis and haemophilus influenzae type b (combined) vaccine
Sponsors
Sichuan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age range: normal people aged 4-6, 18-24 months, 3 months and 2 months; 2) Infants aged 2-3 months should be pregnant at term (37-42 weeks) and 2500g = birth weight = 4000g; 3) Children aged 4-6 years have completed the whole course of immunization with DPT vaccine (Category I vaccine) or combination vaccine containing DPT components and polio vaccine according to the immunization planning procedures, and can provide vaccination records, and have not received the adsorbed diphtheria tetanus combined vaccine (dose 5); 4) Children aged 18-24 months have completed the basic immunization (3 doses) of DPT vaccine and polio vaccine according to the immunization planning procedures, and can provide the vaccination records, and have not received the enhanced immunization of DPT vaccine and polio vaccine; 5) Infants aged 2-3 months did not receive poliomyelitis vaccine, DPT vaccine, Hib vaccine, group A and group C meningococcal polysaccharide conjugate vaccine, and 13 valent pneumococcal polysaccharide conjugate vaccine; 6) The legal guardian/authorized trustee voluntarily signed the informed consent form through informed consent, and was able to comply with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose: 1) Have a history of pertussis, diphtheria, tetanus or polio; 2) Have a history of dystocia (2-3 months old), asphyxia rescue and nervous system damage; 3) Congenital malformations (2-3 months old) or developmental disorders, genetic defects, severe malnutrition, etc; 4) Have a history of epilepsy, convulsions or convulsions, or have a family history of psychosis; 5) Those who have received immunoenhancement or inhibitor treatment within 3 months (continuous oral or infusion for more than 14 days); 6) Has been diagnosed with congenital or acquired immunodeficiency, lymphoma, leukemia or other autoimmune diseases; 7) Absence of spleen and deficiency of spleen function caused by any condition; 8) Known or suspected diseases include: serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, serious systemic skin diseases, and malignant tumors; 9) Have received blood products or immunoglobulin within 3 months before enrollment (it is acceptable to have used hepatitis B immunoglobulin), or plan to use it during the test (before blood sample collection after immunization); 10) Vaccine related high fever (armpit temperature = 39.5 ?) with or without convulsion after previous vaccination of other vaccines; 11) History of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); 12) Previous history of vaccination or severe drug allergy; Or allergic to any component of the vaccine used in the test (mainly including pertussis bacillus antigen, diphtheria toxoid, tetanus toxoid, type I poliovirus (inactivated), type II poliovirus (inactivated), type III poliovirus (inactivated), haemophilus influenzae type b capsular polysaccharide, and combined tetanus protein); Or serious adverse reactions occur after injection of pertussis, diphtheria and tetanus vaccines; 13) The laboratory test indexes of children aged 4-6 years before vaccination are abnormal and clinically significant as determined by clinicians; 14) Being or planning to participate in other clinical trials in the near future; 15) The investigator judged that other situations were not suitable for this clinical trial. Exclusion criteria for follow-up agents: 1) Severe hypersensitivity reaction occurred after the previous dose of experimental vaccine was inoculated; 2) Occurrence of serious adverse events related to the previous dose of trial vaccine; 3) Those newly discovered or newly occurred after the vaccination of the previous dose of trial vaccine that meet the first dose exclusion criteria (excluding Articles 5 and 9 of the first dose exclusion criteria); 4) After the first dose of experimental vaccine was inoculated, poliomyelitis vaccine, DPT vaccine, Hib vaccine, group A and group C meningococcal polysaccharide conjugate vaccine, 13 valent pneumococcal polysaccharide conjugate vaccine were inoculated; 5) Any situation that the researcher believes may affect the evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of AE;Incidence rate of SAE;Changes in clinical significance of laboratory test indicators;Occurrence of adverse events leading to subjects' withdrawal from the trial; | — |
Countries
China
Contacts
Public ContactXiaoping Zhu
Sichuan Provincial Center for Disease Control and Prevention
Outcome results
None listed