Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis
Conditions
Interventions
5-combined vaccine group:
0.5 mL of 5-combined vaccine is administered subcutaneously in the extensor compartment of the upper arm, or intramuscularly in the anterolateral aspect of the thigh or the
Sponsors
Sugino Shigeto
Uno Shingo
KM Biologics Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet all of the following criteria are eligible for the study: (1)Infants who received 3 doses of 4-combined vaccine and Hib vaccine each as a primary immunization (simultaneous administration is acceptable) and who are in the interval of >= 6 months and < 18 months after the third dose of 4-combined vaccine (2) Those whose legally acceptable representatives have provided written informed consent
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria are excluded from the study: (1) Those who have a medical history of Hib infection (based on interview of their legally acceptable representatives) (2) Those who previously exhibited anaphylaxis to components contained in the investigational product (3) Those who are judged as ineligible for participation in this research by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seropositivity rate (>= 1 ug/mL) against polyribosyl ribitol phosphate | — |
Secondary
| Measure | Time frame |
|---|---|
| -Seropositivity rate (>= 0.15 ug/mL) against polyribosyl ribitol phosphate -The geometric mean antibody titer against polyribosyl ribitol phosphate -Changes in antibody titer against polyribosyl ribitol phosphate | — |
Contacts
Public ContactShingo Uno
KM Biologics Co., Ltd.
Outcome results
None listed