Interchangeability between 5-combined vaccine and 4-combined vaccine + Hib vaccine
- Conditions
- Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis
- Registration Number
- JPRN-jRCTs071230050
- Lead Sponsor
- Sugino Shigeto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seropositivity rate (>= 1 ug/mL) against polyribosyl ribitol phosphate
- Secondary Outcome Measures
Name Time Method -Seropositivity rate (>= 0.15 ug/mL) against polyribosyl ribitol phosphate<br>-The geometric mean antibody titer against polyribosyl ribitol phosphate<br>-Changes in antibody titer against polyribosyl ribitol phosphate