Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

Tetanus Clinical Trial

— Venus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458183
• Other study ID #: BR-DTPP-CT-301
• Status: Completed
• Phase: Phase 3
• Start date: February 2, 2015
• Est. completion date: May 5, 2018

Study information

• Verified date: June 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: May 5, 2018
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Weeks to 10 Weeks

Eligibility

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 de?ciency.

• 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.

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• DTaP-IPV combination vaccine
0.5-mL IM
• DTaP vaccine and IPV vaccine
0.5-mL IM

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	KeiMyung University Dongsan Medical Center	Daegu
Korea, Republic of	Gwangmyeong Sungae Hospital	Gyeonggi-do
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Cheil General Hospital	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Eulgi General Hospital	Seoul
Korea, Republic of	Gangnam Sevrance Christian Hospital	Seoul
Korea, Republic of	Hallym University Medical Center	Seoul
Korea, Republic of	KEPCO Medical Center	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	KyungHee University Hospital at Gangdong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Wonju Sevrance Christian Hospital	Wonju
Thailand	Siriraj Hospital	Bangkok
Thailand	Thammasat University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Countries where clinical trial is conducted

Korea, Republic of,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Solicited adverse event/adverse drug reaction	Incidence of Treatment-Emergent Adverse Events	24~26 weeks after the final vaccination
Other	Unsolicited adverse event/adverse drug reaction	Incidence of Treatment-Emergent Adverse Events	24~26 weeks after the final vaccination
Primary	Vaccine response rate	Vaccine response rate of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination; Criteria of vaccine response rate Anti-diphtheria: Antibody titer after the completion of the final vaccination = 0.1 IU/mL anti-tetanus: Antibody titer after the completion of the final vaccination = 0.1 IU/mL anti-PT, anti-FHA: Antibody titer at 4 weeks after the completion of the final vaccination is at least 4 times the baseline antibody titer anti-poliovirus type 1, 2, 3: Serum neutralizing antibody dilution ratio after the completion of the final vaccination = 1:8	4 weeks after the three-dose primary vaccination
Secondary	Geometric mean titer (GMT)	anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination	4 weeks after the three-dose primary vaccination