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The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBVE | Experimental | Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age |
|
| Prevnar13 | Active Comparator | Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBVE | Biological | Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml | 4 weeks after 3rd(last) vaccination | |
| Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios | 4 weeks after 3rd(last) vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer | 4 weeks after 3rd(last) vaccination | |
| Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios | 4 weeks after 3rd(last) vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG chem | Seoul | Gangseo-Gu | 07795 | South Korea |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Prevnar13 | Biological | 13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh |
|
| Solicited adverse events | Baseline(pre-vaccination) up to 7 days after each vaccination |
| Unsolicited adverse events | Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination |
| D007239 | Infections |