Changge Center for Disease Control and Prevention
Xuchang, Henan, 461500, China
NCT Number: NCT04099303
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.
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Notify Me2 month–6 year
All sexes
Interventional
Phase 1
Xuchang, Henan, 461500, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 mL, Intramuscular Other Name: DTcP
2mL, Intramuscular Other Name: DT
0.5 mL, Intramuscular Other Name: DTaP
0.5 mL, Intramuscular Other Name: PENTAXIM
Time frame: within 30 minutes post-vaccination
Occurrence of adverse reactions
Time frame: within 7 days post-vaccination
Occurrence of adverse reactions
Time frame: within 360 days post-vaccination
Occurrence of SAE
Time frame: the fourth day post-vaccination
Occurrence of abnormal changes of laboratory measures
Time frame: within 8-30 days post-vaccination
Occurrence of adverse reactions
Time frame: within 30 days post-vaccination
Occurrence of adverse reactions
CanSino Biologics Inc.
Industry
A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years
Acronym: PCTDTcP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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