Status:
COMPLETED
Immunogenicity and Safety Study of NBP606 in Healthy Infants
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
42-98 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2016
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT02201030
Start Date
September 6 2014
End Date
October 21 2016
Last Update
April 20 2020
Active Locations (1)
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1
Confidential
Seoul, South Korea