| Primary | Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar | Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 1 month after last dose in each group | | | | ID | Title | Description |
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| OG000 | Group 1 | Participants 121 to <212 days of age and received 4 doses of Prevenar. | | OG001 | Group 2 | Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | | OG002 | Group 3 | Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar | | OG003 | Group 4 | Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar. |
| | Units | Counts |
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| Participants | - OG000100
- OG001101
- OG002125
- OG003
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| | Title | Denominators | Categories |
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| Serotype 4 (n= 88, 87, 115, 177) | | | Title | Measurements |
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| - OG0006.90(5.61 to 8.48)
- OG0017.16(6.09 to 8.42)
- OG0027.53(6.70 to 8.46)
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| Primary | Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group | Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Baseline | | | | ID | Title | Description |
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| OG000 | Group 1 | Participants 121 to <212 days of age and received 4 doses of Prevenar. | | OG001 | Group 2 | Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | | OG002 | Group 3 | Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar |
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| Secondary | Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1 | Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 1 month after third dose of Prevenar in Group 1 | | | | ID | Title | Description |
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| OG000 | Group 1 | Participants 121 to <212 days of age and received 4 doses of Prevenar. |
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| Secondary | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1. | GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Pre-vaccination to 1 month after third dose of Prevenar in Group 1 | | | | ID | Title | Description |
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| OG000 | Group 1 | Participants 121 to <212 days of age and received 4 doses of Prevenar. |
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| Secondary | Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2 | Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 1 month after second dose of Prevenar in Group 2 | | | | ID | Title | Description |
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| OG000 | Group 2 | Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. |
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| Secondary | GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2. | GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Pre-vaccination to 1 month after second dose of Prevenar in Group 2 | | | | ID | Title | Description |
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| OG000 | Group 2 | Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. |
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| Secondary | Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3 | Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 1 month after first dose of Prevenar in Group 3 | | | | ID | Title | Description |
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| OG000 | Group 3 | Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar |
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| Secondary | GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3. | GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. | Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Pre-vaccination to 1 month after first dose of Prevenar in Group 3 | | | | ID | Title | Description |
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| OG000 | Group 3 | Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar |
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| Secondary | Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose. | Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 12 months after the last dose | | | | ID | Title | Description |
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| OG000 | Group 1 | Participants 121 to <212 days of age and received 4 doses of Prevenar. | | OG001 | Group 2 | Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | | OG002 | Group 3 | Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar |
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| Secondary | GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose. | GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. | Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Pre-vaccination to 12 months after the last dose | | | | ID | Title | Description |
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| OG000 | Group 1 | Participants 121 to <212 days of age and received 4 doses of Prevenar. | | OG001 | Group 2 | Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | | OG002 | Group 3 | Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar |
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