NCT04618640

To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

A Multicenter, Single-group, Phase III Study to Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Who Completed the Primary Vaccination Against Diphtheria, Tetanus, Pertussis, and Poliomyelitis by Participating in the Phase III Study, BR-DTPP-CT-301, or by Receiving Routine Vaccination

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (estimated)
• Sponsor: Boryung Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV combination vaccine	Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years

Timeline

• Start date: 2019-12-26
• Primary completion: 2020-12-31
• Completion: 2021-07-30
• First posted: 2020-11-06
• Last updated: 2020-11-06

Locations

26 sites across 1 country: South Korea