Pneumococcal Infections
Conditions
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.
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
12 Months to 15 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with the targeted antibody concentration | 1 month after the booster vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentration ratio | 1 month after the booster vaccination |
Countries
South Korea
Outcome results
None listed