This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.
Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment
Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and Pertussis combined vaccine, and not yet received the Diphtheria, Tetanus combined vaccine; (b) Toddlers (aged 18-24 months) enrolled in the study should have received three doses of Diphtheria, Tetanus, and Pertussis combined vaccine as well as three doses of the Polio vaccine, and not yet received the booster dose of Diphtheria, Tetanus, and Pertussis combined vaccine and the Polio vaccine; (c) Infants (aged 3 months) enrolled in the study should not have received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, or meningococcal group A and C polysaccharide conjugate vaccine; (d) Infants (aged 2 months) enrolled in the study should not received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Haemophilus influenzae type b conjugate vaccine.
Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
Previous Diagnosis: Subjects diagnosed with pertussis, tetanus, or diphtheria disease.
Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): Subjects have been with abnormal labor (dystocia, instrumental delivery) or a history of asphyxia, nervous system damage, or clinically confirmed pathological jaundice.
Allergic History: Subjects have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected allergy to any vaccine, or other serious adverse reactions, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria.
Vaccination History: Subjects received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days before vaccination
Sequential
DTacP (one-dose booster)
Biological/VaccineDiphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on Day 0
DTacP (three-dose primary vaccination)
Biological/VaccineDiphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on the M3-M4-M5, M2-M3-M4, or M2-M4-M6 immunization schedule
DT (one-dose booster)
Biological/VaccineDiphtheria-Tetanus Combined Vaccine of 0.5mL on Day 0
DTaP (one-dose booster)
Biological/VaccineDiphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on Day 0
PENTAXIM (one-dose booster)
Biological/VaccineDiphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on Day 0
DTaP (three-dose primary vaccination)
Biological/VaccineDiphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on an M3-M4-M5immunization schedule
PENTAXIM (three-dose primary vaccination)
Biological/VaccineDiphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on the M3-M4-M5 or M2-M3-M4 immunization schedule
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Treatment groupsSee each treatment group below.
Safety index-incidence of adverse events
Incidence of adverse events after the first dose vaccination (Applicable for Infants)
Safety index-incidence of adverse events
Incidence of adverse events after the second dose vaccination (Applicable for Infants)
Safety index-incidence of adverse events
Incidence of adverse events after the third dose vaccination (Applicable for Infants)
Safety index-incidence of adverse events
Incidence of adverse events after the booster dose (Applicable for Toddlers and Children)
Safety index-incidence of serious adverse events
Occurrence of serious adverse events after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against DT
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against TT
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against PT
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.
Immunogenicity index-seropositive rates of neutralizing antibody against DT
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:4.
Immunogenicity index-seropositive rates of neutralizing antibody against PT
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:4.
Immunogenicity index-seropositive rates of neutralizing antibody against FHA
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:4.
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against DT
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
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Institute of Medical Biology, Chinese Academy of Medical Sciences
Lead sponsor
Sichuan Center for Disease Control and Prevention
Collaborator
