13-valent Pneumococcal Vaccine, Pneumococcal Disease
Conditions
Keywords
13 valent Pneumococcal Conjugate Vaccine, Antibody Response, safety, Alaskan Native Children
Brief summary
This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female infants 6 weeks to \< 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures. * Infants who have received Prevnar are eligible to participate, but this is not required. * Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)
Exclusion criteria
* Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | 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. |
| Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | 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. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | 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. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. | 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. |
| Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5. | 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. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. | 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. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Day 1 through Day 7 after vaccination 2 for Group 4 | 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. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Day 1 through Day 7 after vaccination 2 for Group 4 | 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. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | 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. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal OPA GMTs 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3. | 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. |
| Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | 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. |
| Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC | Baseline to 6 months after last vaccination | 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. |
| Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | — |
| Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | — |
| Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | — |
| Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | 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. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | 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. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | 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. |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | 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. |
| GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3. | 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. |
| GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | 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. |
| Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | 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. |
| Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. | 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. |
| Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. | 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. |
| Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. | 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. |
Countries
United States
Participant flow
Recruitment details
Blood sample was optional for subjects living in the Bethel area. Active vaccination stopped when 13-valent pneumococcal conjugate vaccine (13vPnC) was commercially available in Alaska. Study ended after a 6-month follow-up for safety following the last vaccination.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 151 |
| 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. | 51 |
| 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. | 25 |
| 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. | 67 |
| 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. | 79 |
| Total | 373 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Investigator Request | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Parent/Legal Guardian Request | 3 | 2 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 13vPnC Group 4 (2 Catch-Up Doses) | 13vPnC Group 5 (1 Catch-Up Dose) | Total |
|---|---|---|---|---|---|---|
| Age, Customized | 1.4 Months STANDARD_DEVIATION 0.6 | 4.4 Months STANDARD_DEVIATION 0.8 | 7.1 Months STANDARD_DEVIATION 1.6 | 15.2 Months STANDARD_DEVIATION 3.4 | 40.1 Months STANDARD_DEVIATION 11.1 | 12.9 Months STANDARD_DEVIATION 15.9 |
| Sex: Female, Male Female | 73 Participants | 23 Participants | 11 Participants | 36 Participants | 47 Participants | 190 Participants |
| Sex: Female, Male Male | 78 Participants | 28 Participants | 14 Participants | 31 Participants | 32 Participants | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 151 | 4 / 51 | 1 / 25 | 0 / 15 | 0 / 23 | 0 / 16 | 1 / 66 | 0 / 79 |
| serious Total, serious adverse events | 21 / 151 | 2 / 51 | 1 / 25 | 0 / 15 | 0 / 23 | 2 / 16 | 3 / 66 | 0 / 79 |
Outcome results
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.
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 3 | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 23F | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 6A | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 14 | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 6B | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 9V | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 23F | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | 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 | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 9V | 81.8 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 5 | 81.8 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 6A | 72.7 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 14 | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 19A | 72.7 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 4 | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 18C | 63.6 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 23F | 63.6 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 6B | 72.7 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 1 | 81.8 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 3 | 54.5 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 6B | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 18C | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 5 | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 9V | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 6A | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 19F | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 3 | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 7F | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 14 | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 1 | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 19A | 50.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 23F | 50.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 19A | 33.3 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 9V | 66.7 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 5 | 66.7 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 6A | 66.7 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 77.8 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 50.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 50.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 50.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 1 | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 4 | 50.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotype - serotype 18C | 75.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 3 | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 5 | 50.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 7F | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 7F | 33.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotype - serotype 19F | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 6A | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 4 | 50.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotype - serotype 23F | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 6B | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 1 | 12.5 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 9V | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 19A | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotypes - serotype 14 | 88.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Additional serotype - serotype 3 | 37.5 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) | Common serotype - serotype 18C | 33.3 Percentage of Participants |
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.
Time frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Tenderness: Any (n=65,77) | 32.3 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Tenderness: Significant (n=63,77) | 3.2 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Any (n=64,77) | 7.8 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Mild (n=62,76) | 3.2 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Moderate (n=63,77) | 3.2 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Severe (n=63,77) | 1.6 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Any (n=65,77) | 15.4 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Mild (n=63,77) | 11.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Moderate (n=64,77) | 4.7 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Severe (n=63,77) | 1.6 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Mild (n=63,77) | 11.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Tenderness: Any (n=65,77) | 48.1 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Severe (n=63,77) | 2.6 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Tenderness: Significant (n=63,77) | 9.1 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Severe (n=63,77) | 2.6 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Any (n=64,77) | 7.8 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Any (n=65,77) | 13.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Mild (n=62,76) | 2.6 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Redness: Moderate (n=64,77) | 5.2 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 | Swelling: Moderate (n=63,77) | 6.5 Percentage of Participants |
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.
Time frame: Day 1 through Day 7 after vaccination 2 for Group 4
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Tenderness: Any (n=49) | 36.7 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Tenderness: Significant (n=49) | 10.2 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Swelling: Any (n=48) | 10.4 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Swelling: Mild (n=47) | 8.5 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Swelling: Moderate (n=47) | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Swelling: Severe (n=47) | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Redness: Any (n=49) | 6.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Redness: Mild (n=48) | 4.2 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Redness: Moderate (n=48) | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 | Redness: Severe (n=48) | 0.0 Percentage of Participants |
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.
Time frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Fever >39 degrees C but ≤40 degrees C (n=29,43) | 20.7 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Increased sleep (n=66,77) | 33.3 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Decreased appetite (n=66,77) | 31.8 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Decreased sleep (n=66,77) | 24.2 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Fever >40 degrees C (n=28,40) | 7.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Hives (urticaria) (n=66,77) | 3.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Irritability (n=66,77) | 53.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Use of medication to treat symptoms (n=65,77) | 50.8 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Fever ≥38 degrees C but ≤39 degrees C (n=35,47) | 42.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Use of medication to treat symptoms (n=65,77) | 33.8 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Fever ≥38 degrees C but ≤39 degrees C (n=35,47) | 27.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Fever >39 degrees C but ≤40 degrees C (n=29,43) | 11.6 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Fever >40 degrees C (n=28,40) | 0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Decreased appetite (n=66,77) | 24.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Irritability (n=66,77) | 41.6 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Increased sleep (n=66,77) | 22.1 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Decreased sleep (n=66,77) | 11.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 | Hives (urticaria) (n=66,77) | 2.6 Percentage of Participants |
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.
Time frame: Day 1 through Day 7 after vaccination 2 for Group 4
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Fever ≥38 degrees C but ≤39 degrees C (n=26) | 23.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Fever >39 degrees C but ≤40 degrees C (n=22) | 9.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Fever >40 degrees C (n=21) | 0.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Decreased appetite (n=49) | 22.4 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Irritability (n=49) | 57.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Increased sleep (n=49) | 26.5 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Decreased sleep (n=49) | 4.1 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Hives (urticaria) (n=49) | 2.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 | Use of medication to treat symptoms (n=49) | 42.9 Percentage of Participants |
Other Pre-specified
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series | NA Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series | NA Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series | NA Participants |
Other Pre-specified
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose | NA Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose | NA Participants |
Other Pre-specified
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Population: Correlative analysis output data are only available as figures and were not analyzed or presented statistically.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose | NA Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose | NA Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose | NA Participants |
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.
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 3 | 0.79 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 4 | 2.64 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 5 | 2.89 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 14 | 4.78 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 6A | 2.19 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 7F | 3.34 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 19A | 1.87 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 6B | 2.74 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 18C | 1.83 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 19F | 3.55 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 23F | 1.54 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 9V | 1.38 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 1 | 3.33 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 9V | 1.04 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 3 | 1.61 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 23F | 1.03 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 18C | 1.66 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 5 | 1.93 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 6B | 2.59 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 1 | 3.02 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 6A | 2.48 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 14 | 4.08 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 19F | 1.61 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 4 | 2.11 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 19A | 1.35 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 7F | 3.18 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 19A | 0.97 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 7F | 6.21 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 4 | 4.27 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 6B | 28.60 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 9V | 1.60 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotypes - serotype 14 | 10.73 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 18C | 2.99 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 19F | 2.37 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Common serotype - serotype 23F | 3.37 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 1 | 2.87 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 3 | 5.07 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 5 | 1.75 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series | Additional serotype - serotype 6A | 5.41 mcg/mL |
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.
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 4.94 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 4.51 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 9.37 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 9.02 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 1.65 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 4.16 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 4.22 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 7.42 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 16.49 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 8.81 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 3.39 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 4.40 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 3.22 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 5.61 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 22.94 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 5.16 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 16.99 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 5.08 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 6.45 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 5.41 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 1.25 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 1.91 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 2.31 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 4.46 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 3.14 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 4.92 mcg/mL |
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.
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 7.45 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 7.16 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 13.64 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 2.17 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 12.18 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 18C | 2.35 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 19F | 11.00 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 23F | 3.79 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 2.15 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 0.73 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 4.69 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 17.14 mcg/mL |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 10.53 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 3.21 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 18C | 2.22 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 7.79 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 19F | 2.84 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 23F | 2.35 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 5.55 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 4.19 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 1.32 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 2.55 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 12.01 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 3.56 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 2.20 mcg/mL |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 11.42 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 5.85 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 1.63 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 18C | 2.42 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 8.54 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 1.76 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 19F | 3.65 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 3.24 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 8.86 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotype - serotype 23F | 3.96 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 1.30 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 11.32 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 16.70 mcg/mL |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 4.50 mcg/mL |
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.
Time frame: Baseline to 6 months after last vaccination
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC | 0 Participants |
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.
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 75.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 87.5 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 87.5 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 80.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 83.3 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 18C | 80.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 19F | 60.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 50.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 1 | 60.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 19A | 80.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 23F | 88.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 19F | 88.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 5 | 70.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 6A | 90.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 9V | 30.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 4 | 88.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 3 | 90.9 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 19F | 50.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 4 | 75.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 9V | 0.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 14 | 75.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 23F | 66.7 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 1 | 0.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 5 | 60.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 19A | 75.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 1 | 33.3 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 9V | 66.7 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 4 | 66.7 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 5 | 33.3 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 19F | 0.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 14 | 90.9 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 18C | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 19F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotype - serotype 23F | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 100.0 Percentage of Participants |
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.
Time frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 18C | 868 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 7F | 1396 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 3 | 58 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 19F | 151 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 6A | 731 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 5 | 26 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotypes - serotype 4 | 123 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotypes - serotype 9V | 20 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 14 | 332 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 23F | 299 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 19A | 58 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 6B | 1280 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 1 | 41 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 5 | 18 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotypes - serotype 4 | 116 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotypes - serotype 9V | 4 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 19F | 31 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 23F | 81 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 1 | 4 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 3 | 82 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 6A | 1069 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 7F | 1177 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 6B | 1450 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 14 | 71 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 18C | 452 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 19A | 158 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 7F | 3485 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 23F | 566 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 18C | 906 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 6B | 1790 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 19F | 4 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotypes - serotype 4 | 36 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotype - serotype 14 | 449 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 5 | 9 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 3 | 206 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Common serotypes - serotype 9V | 120 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 6A | 984 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 1 | 7 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series | Additional serotype - serotype 19A | 380 Titers |
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.
Time frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 594 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 2870 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 2748 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 402 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 7776 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 218 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 1159 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 128 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 7236 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 9067 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 5910 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 815 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 1584 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 19A | 400 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 6A | 2292 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 4 | 1165 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 6B | 6795 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 9V | 2979 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotypes - serotype 14 | 1547 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 19F | 594 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 23F | 1240 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 1 | 62 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 3 | 202 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 5 | 63 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Additional serotype - serotype 7F | 6086 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose | Common serotype - serotype 18C | 1871 Titers |
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.
Time frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
Population: Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 775 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 23F | 227 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 599 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 428 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 18C | 3311 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 46 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 159 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 87 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 4590 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 1259 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 6B | 1565 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 19F | 397 Titers |
| 13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 3207 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 1688 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 66 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 19F | 73 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 138 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 30 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 23F | 313 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 1575 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 140 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 58 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 6B | 605 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 460 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 551 Titers |
| 13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 18C | 387 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 2765 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 19A | 427 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 1 | 165 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 6A | 6954 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 18C | 4316 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 3 | 402 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 19F | 532 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 220 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 5 | 88 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 779 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 6B | 12470 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Additional serotype - serotype 7F | 6105 Titers |
| 13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) | Pneumococcal OPA GMTs 1 Month After the Toddler Dose | Common serotype - serotype 23F | 1660 Titers |