Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
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
Interventions
BIOLOGICALDTaP-IPV combination vaccine
0.5-mL IM
BIOLOGICALDTaP vaccine and IPV vaccine
0.5-mL IM
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
7 Weeks to 10 Weeks
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Solicited adverse event/adverse drug reaction | 24~26 weeks after the final vaccination | Incidence of Treatment-Emergent Adverse Events |
| Unsolicited adverse event/adverse drug reaction | 24~26 weeks after the final vaccination | Incidence of Treatment-Emergent Adverse Events |
Countries
South Korea, Thailand
Outcome results
None listed