Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS
- Conditions
- PertussisTetanusPoliomyelitisDiphtheria
- Interventions
- Biological: DTaP-IPV combination vaccineBiological: DTaP vaccine and IPV vaccine
- Registration Number
- NCT02458183
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 476
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DTaP-IPV combination vaccine 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 DTaP vaccine and IPV vaccine 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.
- Primary Outcome Measures
Name Time Method Vaccine response rate 4 weeks after the three-dose primary vaccination 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
- Secondary Outcome Measures
Name Time Method Geometric mean titer (GMT) 4 weeks after the three-dose primary vaccination 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
Trial Locations
- Locations (20)
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Cheil General Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Sevrance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Gwangmyeong Sungae Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gangnam Sevrance Christian Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
KEPCO Medical Center
🇰🇷Seoul, Korea, Republic of
Siriraj Hospital
🇹🇭Bangkok, Thailand
Thammasat University
🇹🇭Bangkok, Thailand
KeiMyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Pusan, Korea, Republic of
Eulgi General Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Medical Center
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of