Pneumococcal Vaccines
Conditions
Keywords
Prevenar 13, 13vPnC, Healthy Subjects
Brief summary
This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation. It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 70 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged 42 to 70 days at enrollment. * Determined by medical history, physical examination, and clinical judgment to be eligible for the study * Weight of 3.5 kg or greater at the time of enrollment
Exclusion criteria
* Previous vaccination with licensed or investigational pneumococcal vaccine. * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Contraindication to vaccination with pneumococcal conjugate vaccine. * Receipt of blood products or gamma-globulin since birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | 1 month after the infant series | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here n= participants with valid and determinate IgG concentration to the given serotype. |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | 1 month after the infant series | Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here n= participants with valid and determinate IgG concentration to the given serotype. |
| Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Within 5 days after Dose 1(Day 2 to Day 6) of the infant series | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category. |
| Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category. |
| Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category. |
| Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Within 5 days after Dose 1 (Day 2 to Day 6) of infant series | Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Within 5 days after Dose 2 (Day 2 to Day 6) of infant series | Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Within 5 days after Dose 3 (Day 2 to Day 6) of infant series | Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | Dose 1 up to 28 to 42 days after dose 3 | An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | Informed consent up to Dose 1 | An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 1 month after the infant series | Percentage of participants achieving OPA Titer \>= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. 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. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here n= Number of participants with an antibody titer ≥ LLOQ for the given serotype. |
| Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | 1 month after the infant series | Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here n= participants evaluable =specified category. |
Countries
The Gambia
Participant flow
Pre-assignment details
Total number of participants screened were 526, out of which 500 were enrolled in the study. The study was conducted in Gambia which started on 09 January 2014 and completed on 01 September 2014.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Multi-dose Vial (MDV) Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age. | 250 |
| 13vPnC Single-Dose Syringe (SDS) Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age. | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | No longer met eligibility criteria | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | 13vPnC Multi-dose Vial (MDV) | 13vPnC Single-Dose Syringe (SDS) | Total |
|---|---|---|---|
| Age, Continuous | 57.3 days STANDARD_DEVIATION 8.6 | 56.9 days STANDARD_DEVIATION 8.8 | 57.1 days STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 129 Participants | 130 Participants | 259 Participants |
| Sex: Female, Male Male | 121 Participants | 120 Participants | 241 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 | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 250 | 0 / 250 | 113 / 250 | 107 / 250 | 114 / 249 | 99 / 248 | 97 / 247 | 102 / 244 | 9 / 26 |
| serious Total, serious adverse events | 0 / 250 | 0 / 250 | 0 / 250 | 0 / 250 | 0 / 249 | 0 / 248 | 1 / 247 | 0 / 244 | 0 / 26 |
Outcome results
Primary
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here n= participants with valid and determinate IgG concentration to the given serotype.
Time frame: 1 month after the infant series
Population: Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 4 (n=245,244) | 5.30 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 9V (n=245,244) | 2.83 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 6A (n=243,244) | 2.25 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 14 (n=245,244) | 4.78 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 3 (n=245,243) | 1.38 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 18C (n=245,244) | 3.47 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 6B (n=245,244) | 3.42 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 19A (n=245,244) | 6.49 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 5 (n=245,244) | 2.00 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 19F (n=245,244) | 5.19 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 7F (n=245,244) | 3.92 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 23F (n=245,244) | 2.61 microgram per milliliter (mcg/mL) |
| 13vPnC Multi-dose Vial (MDV) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 1 (n=245,244) | 4.59 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 23F (n=245,244) | 2.17 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 1 (n=245,244) | 4.45 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 3 (n=245,243) | 1.74 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 4 (n=245,244) | 5.28 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 5 (n=245,244) | 1.98 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 6A (n=243,244) | 2.19 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 6B (n=245,244) | 3.24 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 7F (n=245,244) | 4.18 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 9V (n=245,244) | 2.75 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 14 (n=245,244) | 4.96 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 18C (n=245,244) | 2.72 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 19A (n=245,244) | 6.44 microgram per milliliter (mcg/mL) |
| 13vPnC Single-Dose Syringe (SDS) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Serotype 19F (n=245,244) | 5.00 microgram per milliliter (mcg/mL) |
Comparison: Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.82, 1.08]
Comparison: Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.87, 1.21]
Comparison: Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.75, 1.24]
Comparison: Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.87, 1.22]
Comparison: Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.71, 0.9]
Comparison: Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.86, 1.18]
Comparison: Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.85, 1.19]
Comparison: Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.86, 1.22]
Comparison: Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.82, 1.36]
Comparison: Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [1.09, 1.49]
Comparison: Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.82, 1.24]
Comparison: Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.85, 1.26]
Comparison: Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).97.5% CI: [0.98, 1.48]
Primary
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
Population: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was Yes for any day or No for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Any | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Mild | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Moderate | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Severe | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Any | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Mild | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Moderate | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Severe | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Any | 42 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Mild | 32 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Moderate | 13 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Moderate | 14 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Any | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Moderate | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Mild | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Mild | 37 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Moderate | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Redness: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Any | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Tenderness: Any | 47 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Swelling: Mild | 0 participants |
Primary
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
Population: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was Yes for any day or No for all days and 'n' = participants whose response was Yes for any day or No for all days for specified local reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Moderate (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Any (n=247, 247) | 2 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Mild (n=247, 247) | 2 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Severe (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Any (n=247, 247) | 2 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Mild (n=247, 247) | 2 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Moderate (n=247, 247) | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Severe (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Any (n=248, 247) | 34 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Mild (n=248, 247) | 27 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Moderate (n=247, 247) | 7 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Severe (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Moderate (n=247, 247) | 5 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Moderate (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Any (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Mild (n=248, 247) | 28 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Mild (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Moderate (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Severe (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Redness: Severe (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Severe (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Any (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Tenderness: Any (n=248, 247) | 32 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Swelling: Mild (n=247, 247) | 0 participants |
Primary
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
Population: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was Yes for any day or No for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Any | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Mild | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Moderate | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Severe | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Any | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Mild | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Moderate | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Severe | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Any | 37 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Mild | 30 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Moderate | 9 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Moderate | 4 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Any | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Moderate | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Mild | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Mild | 32 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Moderate | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Redness: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Severe | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Any | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Tenderness: Any | 35 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Swelling: Mild | 0 participants |
Primary
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
Population: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was Yes for any day or No for all days. 'n' included participants whose response was Yes for any day or No for all days for specified systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >=38.0 degree C (n=248, 250) | 9 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >=38.0 but <=39.0 degrees C (n=248, 250) | 9 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >39.0 but <=40.0 degrees C (n=248, 250) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >40.0 degrees C (n=248, 250) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Decreased appetite: Any (n=248, 250) | 17 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Decreased appetite: Moderate (n=248, 250) | 17 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Decreased appetite: Severe (n=248, 250) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Any (n=249, 250) | 103 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Mild (n=249, 250) | 86 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Moderate (n=248, 250) | 19 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Severe (n=248, 250) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Any (n=248, 250) | 16 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Mild (n=248, 250) | 11 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Moderate (n=248, 250) | 6 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Severe (n=248, 250) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Use of antipyretic medication (n=248, 250) | 55 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Use of antipyretic medication (n=248, 250) | 58 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >=38.0 degree C (n=248, 250) | 7 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Mild (n=249, 250) | 77 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >=38.0 but <=39.0 degrees C (n=248, 250) | 7 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Mild (n=248, 250) | 10 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >39.0 but <=40.0 degrees C (n=248, 250) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Moderate (n=248, 250) | 17 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Fever: >40.0 degrees C (n=248, 250) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Severe (n=248, 250) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Decreased appetite: Any (n=248, 250) | 26 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Severe (n=248, 250) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Decreased appetite: Moderate (n=248, 250) | 26 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Moderate (n=248, 250) | 4 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Decreased appetite: Severe (n=248, 250) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Increased sleep: Any (n=248, 250) | 14 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Irritability: Any (n=249, 250) | 93 participants |
Primary
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
Population: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was Yes for any day or No for all days. 'n' included participants whose response was Yes for any day or No for all days for specified systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >=38.0 degree C (n=247, 247) | 7 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >=38.0 but <=39.0 degrees C (n=247, 247) | 7 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >39.0 but <=40.0 degrees C (n=247, 247) | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >40.0 degrees C (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Decreased appetite: Any(n=247, 247) | 28 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Decreased appetite: Moderate (n=247, 247) | 28 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Decreased appetite: Severe (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Any (n=248, 247) | 93 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Mild (n=248, 247) | 75 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Moderate (n=247, 247) | 23 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Severe (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Any (n=247, 247) | 24 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Mild (n=247, 247) | 20 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Moderate (n=247, 247) | 4 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Severe (n=247, 247) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Use of antipyretic medication (n=248, 247) | 46 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Use of antipyretic medication (n=248, 247) | 43 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >=38.0 degree C (n=247, 247) | 7 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Mild (n=248, 247) | 67 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >=38.0 but <=39.0 degrees C (n=247, 247) | 7 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Mild (n=247, 247) | 12 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >39.0 but <=40.0 degrees C (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Moderate (n=247, 247) | 17 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Fever: >40.0 degrees C (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Severe (n=247, 247) | 1 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Decreased appetite: Any(n=247, 247) | 18 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Severe (n=247, 247) | 3 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Decreased appetite: Moderate (n=247, 247) | 18 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Moderate (n=247, 247) | 1 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Decreased appetite: Severe (n=247, 247) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Increased sleep: Any (n=247, 247) | 14 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Irritability: Any (n=248, 247) | 83 participants |
Primary
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
Population: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was Yes for any day or No for all days. 'n' included participants whose response was Yes for any day or No for all days for specified systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >=38.0 degree C (n=246, 241) | 3 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >=38.0 but <=39.0 degrees C (n=246, 241) | 3 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >39.0 but <=40.0 degrees C (n=246, 241) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >40.0 degrees C (n=246, 241) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Decreased appetite: Any (n=246, 242) | 24 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Decreased appetite: Moderate (n=246, 242) | 24 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Decreased appetite: Severe (n=246, 241) | 0 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Any (n=246, 243) | 83 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Mild (n=246, 242) | 71 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Moderate (n=246, 242) | 15 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Severe (n=246, 241) | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Any (n=246, 241) | 12 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Mild (n=246, 241) | 10 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Moderate (n=246, 241) | 2 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Severe (n=246, 241) | 1 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Use of antipyretic medication (n=246, 241) | 34 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Use of antipyretic medication (n=246, 241) | 36 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >=38.0 degree C (n=246, 241) | 8 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Mild (n=246, 242) | 74 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >=38.0 but <=39.0 degrees C (n=246, 241) | 7 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Mild (n=246, 241) | 11 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >39.0 but <=40.0 degrees C (n=246, 241) | 1 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Moderate (n=246, 242) | 18 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Fever: >40.0 degrees C (n=246, 241) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Severe (n=246, 241) | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Decreased appetite: Any (n=246, 242) | 20 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Severe (n=246, 241) | 5 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Decreased appetite: Moderate (n=246, 242) | 19 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Moderate (n=246, 241) | 1 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Decreased appetite: Severe (n=246, 241) | 1 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Increased sleep: Any (n=246, 241) | 12 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Irritability: Any (n=246, 243) | 92 participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
Time frame: Dose 1 up to 28 to 42 days after dose 3
Population: Safety population included all participants who received at least 1 dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | AEs | 123 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | SAEs | 1 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | AEs | 127 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | SAEs | 0 participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.
Time frame: Informed consent up to Dose 1
Population: Safety population: participants who received at least 1 dose of study vaccine. Here N= participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | AEs | 2 participants |
| 13vPnC Multi-dose Vial (MDV) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | SAEs | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | AEs | 0 participants |
| 13vPnC Single-Dose Syringe (SDS) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | SAEs | 0 participants |
| Screened Only | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | AEs | 9 participants |
| Screened Only | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | SAEs | 0 participants |
Primary
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here n= participants with valid and determinate IgG concentration to the given serotype.
Time frame: 1 month after the infant series
Population: Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 4 (n=245,244) | 99.6 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 9V (n=245,244) | 98.0 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 6A (n=243,244) | 96.3 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 14 (n=245,244) | 97.6 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 3 (n=245,243) | 98.8 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 18C (n=245,244) | 99.2 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 6B (n=245,244) | 95.1 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 19A (n=245,244) | 99.6 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 5 (n=245,244) | 95.9 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 19F (n=245,244) | 96.7 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 7F (n=245,244) | 99.6 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 23F (n=245,244) | 95.9 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 1 (n=245,244) | 99.2 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 23F (n=245,244) | 95.9 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 1 (n=245,244) | 100.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 3 (n=245,243) | 99.6 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 4 (n=245,244) | 99.6 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 5 (n=245,244) | 97.1 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 6A (n=243,244) | 97.5 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 6B (n=245,244) | 95.1 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 7F (n=245,244) | 100.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 9V (n=245,244) | 98.4 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 14 (n=245,244) | 98.4 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 18C (n=245,244) | 98.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 19A (n=245,244) | 98.8 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Serotype 19F (n=245,244) | 97.1 percentage of participants |
Comparison: Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-3.4, 1.2]
Comparison: Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-3.7, 1.6]
Comparison: Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-2.3, 2.4]
Comparison: Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-5.4, 2.8]
Comparison: Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-5.3, 2.6]
Comparison: Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-4.7, 4.7]
Comparison: Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-2.7, 1.6]
Comparison: Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-3.8, 2.8]
Comparison: Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-4.3, 2.5]
Comparison: Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-1.6, 4.5]
Comparison: Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-1.6, 3.6]
Comparison: Serotype 19F: Exact 2-sided confidence interval (based on Chan \& Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.97.5% CI: [-4.4, 3.5]
Comparison: Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.97.5% CI: [-4.3, 4.4]
Secondary
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Percentage of participants achieving OPA Titer \>= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. 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. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here n= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
Time frame: 1 month after the infant series
Population: Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 4 (n=159,159) | 100.0 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 9V (n=158,160) | 79.7 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 6A (n=160,160) | 99.4 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 14 (n=157,160) | 81.5 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 3 (n=160,160) | 98.8 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 18C (n=159,160) | 99.4 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 6B (n=156,155) | 96.8 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 19A (n=160,160) | 95.6 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 5 (n=160,159) | 83.1 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 19F (n=158,159) | 93.7 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 7F (n=159,160) | 100.0 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 23F (n=159,160) | 96.2 percentage of participants |
| 13vPnC Multi-dose Vial (MDV) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 1 (n=159,160) | 71.7 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 23F (n=159,160) | 97.5 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 1 (n=159,160) | 79.4 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 3 (n=160,160) | 100.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 4 (n=159,159) | 100.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 5 (n=160,159) | 85.5 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 6A (n=160,160) | 99.4 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 6B (n=156,155) | 96.8 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 7F (n=159,160) | 100.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 9V (n=158,160) | 75.0 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 14 (n=157,160) | 89.4 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 18C (n=159,160) | 99.4 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 19A (n=160,160) | 97.5 percentage of participants |
| 13vPnC Single-Dose Syringe (SDS) | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Serotype 19F (n=158,159) | 94.3 percentage of participants |
Comparison: Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-17.2, 1.9]
Comparison: Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-4.4, 1.1]
Comparison: Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-2.3, 2.3]
Comparison: Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-10.6, 5.7]
Comparison: Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-2.9, 2.8]
Comparison: Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-4.5, 4.6]
Comparison: Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-2.3, 2.3]
Comparison: Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-4.5, 14.1]
Comparison: Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-15.8, 0]
Comparison: Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-2.9, 2.9]
Comparison: Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-6.6, 2.4]
Comparison: Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-6.3, 4.9]
Comparison: Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.95% CI: [-5.8, 3]
Secondary
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here n= participants evaluable =specified category.
Time frame: 1 month after the infant series
Population: Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 4 (n=159,159) | 1666 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 9V (n=158,160) | 709 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 6A (n=160,160) | 1690 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 14 (n=157,160) | 567 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 3 (n=160,160) | 97 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 18C (n=159,160) | 2792 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 6B (n=156,155) | 1990 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 19A (n=160,160) | 305 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 5 (n=160,159) | 79 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 19F (n=158,159) | 430 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 7F (n=159,160) | 2891 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 23F (n=159,160) | 918 titer |
| 13vPnC Multi-dose Vial (MDV) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 1 (n=159,160) | 48 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 23F (n=159,160) | 998 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 1 (n=159,160) | 52 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 3 (n=160,160) | 122 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 4 (n=159,159) | 1492 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 5 (n=160,159) | 80 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 6A (n=160,160) | 1968 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 6B (n=156,155) | 2014 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 7F (n=159,160) | 3450 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 9V (n=158,160) | 706 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 14 (n=157,160) | 786 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 18C (n=159,160) | 1605 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 19A (n=160,160) | 329 titer |
| 13vPnC Single-Dose Syringe (SDS) | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Serotype 19F (n=158,159) | 470 titer |
Comparison: Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.8, 1.22]
Comparison: Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.7, 1.06]
Comparison: Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.74, 1.33]
Comparison: Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.7, 1]
Comparison: Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.79, 1.27]
Comparison: Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.48, 1.08]
Comparison: Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [1.38, 2.19]
Comparison: Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.74, 1.16]
Comparison: Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.71, 1.18]
Comparison: Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.67, 1.25]
Comparison: Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.89, 1.39]
Comparison: Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.7, 1.2]
Comparison: Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).95% CI: [0.69, 0.93]