Polio
Conditions
Interventions
For infants who had received one dose of oral polio vaccine, Doses 2-4 were administered using DPT-IPV.
For infants who had received one dose of oral polio vaccine and DPT vaccines, Doses 2-4 were adm
Sponsors
College of Healthcare Management
Sanofi Pasteur S.A. The Research Foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy infants and children aged 3-74 months without any history of acute poliomyelitis, diphtheria, pertussis, or tetanus.
Exclusion criteria
Exclusion criteria: Obvious history of anaphylaxis caused by food or drugs; receipt of any live vaccine within the preceding 27 days; receipt of any inactivated vaccine within the preceding 6 days; receipt of any blood transfusion or gamma globulin preparation within the preceding 3 months; receipt of immunosuppressants (except for external use), gamma globulin preparation (200 mg/kg or more), prednisolone (2 mg/kg/day or more) as an adrenocorticosteroid preparation (except for external use), or immunosuppressive therapy (including radiotherapy) within the preceding 6 months; congenital or acquired immunodeficiency; participation in a separate clinical trial (including individuals who had completed a clinical trial in the last 6 months); and individuals who pediatricians deemed ineligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the immunogenicity of polio vaccines, geometric mean titer (GMT), fold rise, and seroprotection proportion were calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze descriptive information on safety (post-vaccination adverse reactions), frequencies of each local and systemic reaction were calculated. | — |
Countries
Japan
Contacts
Public ContactMotoki Ishibashi
PS Clinic, Medical Co. LTA Clinical Research Department
Outcome results
None listed