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

NCT04618640 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2020-11-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Boryung Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Byeonguk Eun · Eulji University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-26
Primary Completion
2020-12-31
Completion
2021-07-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618640 on ClinicalTrials.gov