Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
3상
완료
NCT00761631
| 대상 질환 | Healthy Subjects |
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| 임상 단계 | 3상 |
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| 스폰서 | Pfizer |
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| 상태 | 완료 |
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| 참여자 수 | 1,200 명 |
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| 중재(약물) | 13 valent pneumococcal conjugate vaccine |
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| 시작일 | 2008년 11월 18일 |
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| 완료일 | 2010년 8월 10일 |
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| 결과 공개일 | 2011년 8월 10일 |
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요약
This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2 · Percentage of participants
| 13vPnC Group 1 (Cohort 1) | 98.2 Percentage of participants |
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| 13vPnC Group 2 (Cohort 1) | 100.0 Percentage of participants |
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| 13vPnC Group 1 (Cohort 1) | 100.0 Percentage of participants |
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| 13vPnC Group 2 (Cohort 1) | 100.0 Percentage of participants |
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| 13vPnC Group 1 (Cohort 1) | 100.0 Percentage of participants |
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| 13vPnC Group 2 (Cohort 1) | 100.0 Percentage of participants |
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
28 to 42 days after dose 1 for Group 3 · mcg/mL
| 13vPnC Group 3 | 8.45 mcg/mL |
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| 13vPnC Group 3 | 53.56 mcg/mL |
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| 13vPnC Group 3 | 9.51 mcg/mL |
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| 13vPnC Group 3 | 29.36 mcg/mL |
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| 13vPnC Group 3 | 8.23 mcg/mL |
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| 13vPnC Group 3 | 17.58 mcg/mL |
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Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
28 to 42 days after dose 1 for Group 3 and 4 · titer
| 13vPnC Group 3 | 6912 titer |
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| 13vPnC Group 4 | 4629 titer |
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| 13vPnC Group 3 | 14224 titer |
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| 13vPnC Group 4 | 14996 titer |
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| 13vPnC Group 3 | 4485 titer |
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| 13vPnC Group 4 | 4733 titer |
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| GMT Ratio | 1.5 (95% CI 1.24–1.80) |
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