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Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants

NCT02458183•Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Detailed Description

A multinational, multicenter, randomized, comparative, open-label, phase 3 study Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
•Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
•Male and female infants who are identified to be healthy based on physical examination and medical history.

Exclusion Criteria

•Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
•Subjects who have moderate or severe acute disease (regardless of fever).
•Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
•Subjects who have major congenital defects.
•Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
•Subjects who have abnormalities in the immune system, or congenital/acquired immune deﬁciency.
•Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
•Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
•Subjects who are allergic to the ingredients of the investigational products.
•Subjects who have received immunoglobulins or blood products or plan to get those medications.
+3 more criteria

Locations (20)

Inje University Busan Paik Hospital

Busan, South Korea

KeiMyung University Dongsan Medical Center

Daegu, South Korea

Gwangmyeong Sungae Hospital

Gyeonggi-do, South Korea

Wonkwang University Hospital

Iksan, South Korea

Inha University Hospital

Incheon, South Korea

Pusan National University Yangsan Hospital

Pusan, South Korea

Asan Medical Center

Seoul, South Korea

Cheil General Hospital

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Eulgi General Hospital

Seoul, South Korea

Key Dates

Start Date

February 2, 2015

Primary Completion Date

December 19, 2017

Completion Date

May 5, 2018

Last Updated

June 28, 2023

Enrollment

476

ACTUAL participants

Conditions

DiphtheriaTetanusPertussisPoliomyelitis

Interventions

DTaP-IPV combination vaccine

BIOLOGICAL

DTaP vaccine and IPV vaccine

BIOLOGICAL

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

NCT07203755

Diphtheria, Tetanus and Acellular PertussisEpidemic Meningitis+1 more

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RECRUITINGPHASE3

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

NCT07112144

Prevent Whooping CoughPrevent Diphtheria+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

Inclusion Criteria

Exclusion Criteria

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy