NCT05870618

Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children

Immunogenicity and Safety of Adsorbed Diphtheria, Tetanus, Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Children：a Randomized, Controlled Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 72 Months – 84 Months
• Healthy volunteers: Accepted

Summary

This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.

Detailed description

A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Wuhan Biological Products Co., LTD. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.

Conditions

• Vaccine Reaction

Interventions

Type	Name	Description
BIOLOGICAL	vaccinate with DTap	vaccinate with DTap
BIOLOGICAL	vaccinate with DT	vaccinate with DT

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-01
• Completion: 2024-11-01
• First posted: 2023-05-23
• Last updated: 2023-05-23

Locations

2 sites across 1 country: China