Immunogenicity and Safety Study of NBP606 in Healthy Infants
Phase 3
Completed
- Conditions
- Pneumococcal Infections
- Registration Number
- NCT02201030
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief Summary
This study will assess the immunogenicity and safety of primary 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
- 577
Inclusion Criteria
- Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
- The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria
- Known hypersensitivity to any components of the pneumococcal vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient conditions
- Coagulation disorder contraindicating IM(intramuscular) vaccination
- Subject has received any licensed vaccine(not including BCG and Hepatitis B)
- 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 primary vaccination
- Secondary Outcome Measures
Name Time Method Geometric mean concentration ratio 1 month after the primary vaccination
Trial Locations
- Locations (1)
Confidential
🇰🇷Seoul, Korea, Republic of
Confidential🇰🇷Seoul, Korea, Republic of