Pertussis, Diphtheria, Tetanus, Poliomyelitis, and Haemophilus influenzae type b infection
Conditions
Interventions
6 years(Group A):DTacP-sIPV/Hib(WIBP), Receive a single dose
18~24months(Group B1):DTacP-sIPV/Hib(WIBP), Receive a single dose
18~24months(Group B2):DTacP-IPV/Hib(PENTAXIM)
Receive a single dose
2 months(Group C1):DTacP-sIPV/Hib(WIBP),Administered as one dose each at 2, 4, 6, and 18~24 months of age
2 months(Group C2):DTaP+sIPV,Administer one dose each of DTaP and sIPV concurrently according to the 2, 4, 6, and 18~24 months of age schedule
2 months(Group C3):DTacP-IPV/Hib(PENTAXIM),Administered as one dose each at 2, 4, 6, and 18~24 months of age
2 months(Group C4):DTacP(WIBP),Administered as one dose each at 2, 4, 6, and 18~24 months of age
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the first dose: 1. Age range: children aged 6 years, toddlers aged 18~24 months, and infants aged 2 months; 2. Children aged 6 years have completed the 4-dose primary series of the diphtheria, tetanus, and pertussis vaccine or combined vaccines containing the diphtheria-tetanus-pertussis component according to the national immunization schedule, can provide vaccination records, and have not received the fifth dose of the adsorbed acellular diphtheria, tetanus, and pertussis combined vaccine; 3. Toddlers aged 18~24 months have completed the primary immunization (3 doses) against diphtheria, tetanus, pertussis, and poliomyelitis according to the national immunization schedule, can provide vaccination records, and have not received the booster doses for the diphtheria-tetanus-pertussis vaccine, poliovirus vaccine, or Haemophilus influenzae type b (Hib) vaccine; 4. Infants aged 2 months have not been vaccinated with the poliovirus vaccine, diphtheria-tetanus-pertussis vaccine, Haemophilus influenzae type b (Hib) vaccine, group A and C meningococcal polysaccharide conjugate vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or other conjugate vaccines that use diphtheria or tetanus toxoid as a carrier; 5. The legal guardian or their delegate, after being informed and providing consent, voluntarily signs the informed consent form and is capable of complying with the requirements of the clinical trial protocol; Booster immunization phase inclusion criteria: 1.Participants who received the first dose at 2 months of age must have completed the 3-dose primary vaccination series of this clinical trial, be between 18 and 24 months of age at the time of the booster, and must not have received a booster dose of the diphtheria, tetanus, and pertussis (DTaP) vaccine, the inactivated poliovirus vaccine (IPV) (except for those in Group C4), and the Haemophilus influenzaetype b (Hib) vaccine (except for those in Groups C2 and C4); 2.In the investigator's judgment, the participant's legal guardian or their delegate is capable of complying with the requirements of the clinical trial protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose: 1.History of pertussis, diphtheria, tetanus, poliomyelitis, or Haemophilus influenzae type b infection; or contact with an individual diagnosed with pertussis, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection within the past 30 days; 2. For the 2-month-old infant participants, as per the birth certificate: preterm birth (delivery prior to 37 weeks of gestation), postterm birth (delivery after 42 weeks of gestation), or birth weight =39.5°C), with or without convulsions, following previous vaccination(s); 11. History of severe allergic reactions to vaccines, such as dyspnea, or generalized urticaria; 12. Allergy to any component of the investigational vaccine; 13. For children aged 6 years and toddlers aged 18-24 months: abnormal laboratory test results prior to vaccination deemed clinically significant by the clinical investigator; 14. Currently participating or planning to participate in other clinical trials; 15. Any other condition considered by the investigator as inappropriate for participation in this clinical trial; Note: For all 2-month-old infant participants after enrollment, vaccination with the 13-valent pneumococcal polysaccharide conjugate vaccine and meningococcal conjugate vaccine according to the local immunization schedule is not restricted, provided the intervals between these vaccinations and the investigational vaccine administration comply with the protocol requirements; emergency vaccinations are not restricted. Exclusion criteria for the second and third doses: 1.Participants who experienced severe hypersensitivity reactions after the previous dose of the investigational vaccine. 2.Participants who experienced serious adverse events determined to be causally related to the previous dose of the investigational vaccine. 3.New conditions identified or developed after the first dose that render the participant ineligible according to the initial inclusion criteria or eligible according to the initial exclusion criteria. The investigator will assess whether the participant can continue in the trial. 4.Receipt of poliovirus vaccine (except for participants in Group C4), diphtheria, te
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The positive rate of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP antibody;The seroconversion rate of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP antibody;The GMC/GMT of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP antibody;The GMI of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP antibody; | — |
Countries
China
Contacts
Public ContactXuhua Guan
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed