Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

NCT ID: NCT02458183

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 476 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2018-05-05

Brief 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

Conditions

Diphtheria; Tetanus; Pertussis; Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DTaP-IPV combination vaccine

Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of right thigh at the age of 2, 4, and 6 months

Group Type: EXPERIMENTAL

DTaP-IPV combination vaccine

Intervention Type: BIOLOGICAL

0.5-mL IM

DTaP vaccine and IPV vaccine

Product name: : Boryung DTaP Vaccine Inj. (Prefilled syringe) (Absorbed diphtheria, tetanus toxoid, and purified pertussis combination vaccine) Dosage and administration: A 0.5-mL dose is administered 3 times intramuscularly in the anterolateral aspect of right thigh at the age of 2, 4, and 6 months.

Product name: IPVAX INJ. PREFILLED SYRINGE INJ. Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of left thigh at the age of 2, 4, and 6 months.

Group Type: ACTIVE_COMPARATOR

DTaP vaccine and IPV vaccine

Intervention Type: BIOLOGICAL

0.5-mL IM

Interventions

DTaP-IPV combination vaccine

0.5-mL IM

Intervention Type: BIOLOGICAL

DTaP vaccine and IPV vaccine

0.5-mL IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Boryung DTaP Vaccine Inj. (Prefilled syringe); IPVAX INJ. PREFILLED SYRINGE INJ

Eligibility Criteria

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.
• Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
• Subjects who are currently participating or planning to participate in other clinical studies during the study period.
• Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.

• Minimum Eligible Age: 7 Weeks
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HJ Jung

Role: STUDY_DIRECTOR

Boryung Pharmaceutical Co., Ltd

Locations

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

Gangnam Sevrance Christian Hospital

Seoul, , South Korea

Hallym University Medical Center

Seoul, , South Korea

KEPCO Medical Center

Seoul, , South Korea

Korea Cancer Center Hospital

Seoul, , South Korea

KyungHee University Hospital at Gangdong

Seoul, , South Korea

KyungHee University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Wonju Sevrance Christian Hospital

Wŏnju, , South Korea

Siriraj Hospital

Bangkok, , Thailand

Thammasat University

Bangkok, , Thailand

Countries

South Korea; Thailand

Other Identifiers

BR-DTPP-CT-301

Identifier Type: -

Identifier Source: org_study_id