Pneumococcal Infections
Conditions
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.
Interventions
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with the targeted antibody concentration | 1 month after the primary vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentration ratio | 1 month after the primary vaccination |
Countries
South Korea
Outcome results
None listed