NCT04099303

Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 2 Months – 6 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed	0.5 mL, Intramuscular Other Name: DTcP
BIOLOGICAL	Diphtheria and Tetanus Combined Vaccine, Adsorbed	2mL, Intramuscular Other Name: DT
BIOLOGICAL	Diphtheria-tetanus-acellular pertussis vaccine	0.5 mL, Intramuscular Other Name: DTaP
BIOLOGICAL	Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine	0.5 mL, Intramuscular Other Name: PENTAXIM

Timeline

• Start date: 2020-04-28
• Primary completion: 2021-10-27
• Completion: 2021-11-25
• First posted: 2019-09-23
• Last updated: 2022-10-31

Locations

1 site across 1 country: China