Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine (DT),Diphtheria-tetanus-acellular pertussis vaccine(DTaP) or PENTAXIM(DTaP-IPV-Hib) in participants.
Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
0.5 mL, Intramuscular Other Name: DTcP
2mL, Intramuscular Other Name: DT
0.5 mL, Intramuscular Other Name: DTaP
Changge Center for Disease Control and Prevention
Xuchang, Henan, China
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 30 minutes post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 7 days post-vaccination
Safety items of SAE: Occurrence of SAE
Occurrence of SAE
Time frame: within 360 days post-vaccination
Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures
Occurrence of abnormal changes of laboratory measures
Time frame: the fourth day post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 8-30 days post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 30 days post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.5 mL, Intramuscular Other Name: PENTAXIM