A Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old Infants

20220102C

The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.

2023-12-21

2025-05-25

2028-12-25

Recruiting

Early phase I

1584

Inclusion Criteria: * Basic immune stage: 1. 3-month-old infants who can provide valid identification documents; 2. Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g); 3. The legal guardian of the subject voluntarily agrees to their child's participation in the trial and signs a written informed consent form; 4. The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits; 5. Has not received a vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine; 6. Active control group 2 has not been vaccinated with any vaccine containing the active ingredients of poliomyelitis vaccine or haemophilus influenzae vaccine; * Enhanced immunity stage: 1. Infants and young children aged 18-24 months who have been enrolled in this clinical trial at the age of 3 months; 2. Basic immunization has been completed in this clinical trial; 3. According to the researcher's opinion, the subjects and their legal guardians are able to comply with the requirements of the clinical trial protocol. Exclusion Criteria: * Basic immune stage: 1. Has a history of pertussis, diphtheria, or tetanus; 2. Has any history of severe allergies to vaccination in the past; 3. Allergy to any component of the experimental vaccine; 4. Has a history or family history of epilepsy, convulsions, encephalopathy, mental illness; 5. Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection; 6. Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the trial including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc; 7. Has the history of severe abnormal production process, suffocation rescue, neurological damage, and current pathological jaundice; 8. Suffering from infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, or HIV infection confirmed by parents; 9. Within 3 months before to enrollment, has received systemic corticosteroid treatment (any route of administration, ≥ 2mg/kg/day) for ≥ 14 days, such as prednisone, inhaled steroids such as budesonide, and fluticasone; Or being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before enrollment; 10. Within 3 months before enrollment，has received treatment with immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) ; 11. Participating in or planning to participate in clinical trials of other drugs in the near future; 12. According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial. * Enhanced immunity stage: 1. Newly discovered severe allergic history to any previous vaccination; 2. Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection; 3. Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the test, including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc; 4. After completing basic immunization, subjects were vaccinated with other vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine before booster immunization; 5. Participating in or planning to participate in clinical trials of other drugs in the near future; 6. According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.

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2024-04-03