Pertussis
Conditions
Interventions
Control group 1:DTcP-wIPV/Hib Vaccination
Control group 2:DTaP vaccination
Test group:DTcP vaccination
Sponsors
Hubei Center For Disease Control And Prevention
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: Basic, second and third doses and booster immunizations 1. Resident healthy population aged 2 months old; 2. Obtaining consent from the legal guardian of the study participant and signing the informed consent form; 3. Study participants and legal guardians are able to comply with the requirements of the clinical trial protocol and can provide valid identification documents; 4. Have not been vaccinated with DPT, polio vaccine, Haemophilus influenzae type b (Hib) vaccine; 5. Those with axillary temperature <=37.0°C; Immunization persistence 1. Previous participants in the Phase III clinical trial of this product who received the full course of the test group vaccine; 2. Obtain consent from the volunteer's legal guardian and sign an informed consent form; 3. Volunteers and legal guardians are able to comply with clinical trial protocol requirements;
Exclusion criteria
Exclusion criteria: Basic immunization 1. History of pertussis, diphtheria and tetanus; 2. Preterm infants (delivered before the 37th week of gestation), low birth weight infants (birth weight 37.0°C at the time of vaccination(Vaccination can be postponed within the time window specified in the protocol); Immunization persistence 1. Have received other DPT vaccines or combination vaccines containing its components after enrollment for basic immunization. 2. History of pertussis, diphtheria and tetanus after basic immunization enrollment; 3. Newly diagnosed autoimmune or immunodeficiency diseases, including human immunodeficiency virus (HIV) infection, after enrollment in basic immunization; 4. Absence of spleen, defective spleen function due to any condition after basic immunization enrollment; 5. Individuals treated with immune-enhancing or inhibiti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| geometric mean concentration (GMC);Antibody positivity rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event(AE);serious adverse event(SAE); | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Center For Disease Control And Prevention
Outcome results
None listed