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Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

NCT02458183 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2023-06-28

No results posted yet for this study

Summary

The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis

Interventions

BIOLOGICAL

DTaP-IPV combination vaccine

0.5-mL IM

BIOLOGICAL

DTaP vaccine and IPV vaccine

0.5-mL IM

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • HJ Jung · Boryung Pharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2017-12-19
Completion
2018-05-05

Countries

  • South Korea
  • Thailand

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 NCT02458183 on ClinicalTrials.gov