Immunogenicity and Safety Study of NBP606 in Healthy Toddlers
Phase 3
Completed
- Conditions
- Pneumococcal Infections
- Registration Number
- NCT02927444
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief Summary
This study will assess the immunogenicity and safety of booster vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 462
Inclusion Criteria
- Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period.
- The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria
- Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study
- Known hypersensitivity to any components of the pneumococcal vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient conditions
- Coagulation disorder contraindicating IM(intramuscular) vaccination
- Participation to another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of subjects with the targeted antibody concentration 1 month after the booster vaccination
- Secondary Outcome Measures
Name Time Method Geometric mean concentration ratio 1 month after the booster vaccination
Trial Locations
- Locations (1)
Clinical Research Center
🇰🇷Seoul, Korea, Republic of
Clinical Research Center🇰🇷Seoul, Korea, Republic of