| Primary | Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series | Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. | | OG002 | 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
| | | Title | Denominators | Categories |
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| Common serotypes - serotype 4 | | | Title | Measurements |
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| - OG000100.0(71.5 to 100.0)
- OG001100.0(54.1 to 100.0)
- OG002100.0(29.2 to 100.0)
|
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| Primary | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Primary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Secondary | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Secondary | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic | Posted | | Number | | Percentage of Participants | | Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Secondary | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic | Posted | | Number | | Percentage of Participants | | Day 1 through Day 7 after vaccination 2 for Group 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. |
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| Secondary | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category. | Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic | Posted | | Number | | Percentage of Participants | | Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Secondary | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category. | Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic | Posted | | Number | | Percentage of Participants | | Day 1 through Day 7 after vaccination 2 for Group 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. |
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| Other Pre-specified | Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC | In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC's AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC. | | Posted | | Number | | Participants | | Baseline to 6 months after last vaccination | | | | ID | Title | Description |
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| OG000 | 13vPnC (All Participants) | All participants 6 weeks to <5 years of age who received at least one single IM 0.5 mL dose of 13vPnC in either the infant series or the toddler dose. |
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| Other Pre-specified | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Other Pre-specified | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw. | Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw. | Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw. | Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Other Pre-specified | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis. | Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) |
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| Other Pre-specified | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis. | Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | |
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| Other Pre-specified | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis. | Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Other Pre-specified | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers. | Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers. | Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers. | Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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| Other Pre-specified | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series | | Correlative analysis output data are only available as figures and were not analyzed or presented statistically. | Posted | | Number | | Participants | | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. | | OG002 | 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose | | Correlative analysis output data are only available as figures and were not analyzed or presented statistically. | Posted | | Number | | Participants | | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose. | | OG001 | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. | | OG002 | 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose. |
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| Other Pre-specified | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose | | Correlative analysis output data are only available as figures and were not analyzed or presented statistically. | Posted | | Number | | Participants | | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | | | | ID | Title | Description |
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| OG000 | 13vPnC Group 4 (2 Catch-Up Doses) | Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart. | | OG001 | 13vPnC Group 5 (1 Catch-Up Dose) | Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC. |
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