13-valent Pneumococcal Vaccine, Immunization, Premature Birth, Safety
Conditions
Keywords
13-valent pneumococcal conjugate vaccine, premature, immunization, safety.
Brief summary
The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
No
Inclusion criteria
* Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
Exclusion criteria
* Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines. * Previous anaphylactic reaction or allergy to any vaccine * Contraindication to vaccination * Known or suspected immune deficiency or immune suppression * Major known congenital malformation or serious chronic disorder * Significant neurological disorder * Participation to another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 1 month after the infant series | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 month after the infant series | Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Within 7 days after Dose 1 of the infant series | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Within 7 days after Dose 2 of the infant series | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Within 7 days after Dose 3 of the infant series | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Within 7 days after the toddler dose | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Within 7 days after Dose 1 of the infant series | Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Within 7 days after Dose 2 of the infant series | Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Within 7 days after Dose 3 of the infant series | Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Within 7 days after the toddler dose | Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category. |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series | Dose 1 up to 1 month after Dose 3 (infant series) | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series | 1 Month after Dose 3 of the infant series up to toddler dose | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose | Toddler dose up to 1 Month after toddler dose | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose | 1 month after toddler dose up to 1-year follow-up | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose | 1-year follow-up after toddler dose to 2-year follow-up after toddler dose | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 1 Month After Toddler Dose | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 1 Year After Toddler Dose | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 2 Years After Toddler Dose | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 1 Month After Infant Series | Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose | GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws. |
| Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 1 Month After Toddler Dose | Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. |
| Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 1 Year After Toddler Dose | Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. |
| Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 2 Years After Toddler Dose | Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. |
| Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | Before Toddler Dose (pre-vaccination) | Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 1 Month After Infant Series | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 1 month after the toddler dose | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 month after the toddler dose | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | Before Toddler Dose (pre-vaccination) | Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 1 Month After Toddler Dose | Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 1 Year After Toddler Dose | The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 2 Years After Toddler Dose | The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 1 Month After Infant Series | Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | Before Toddler Dose (pre-vaccination) | Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 Month After Toddler Dose | Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 1 Year After Toddler Dose | The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 2 Years After Toddler Dose | The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 1 Month After Infant Series | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | Before the toddler dose (pre-vaccination) | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
Countries
Poland, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Group 1 (Preterm Infant) Preterm infant participants (gestational age \[GA\] less than \[\<\] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to \[\>=\] 32 weeks and \<37 weeks), Group 1B (GA \>=29 weeks and \<32 weeks) and Group 1C (GA \<29 weeks). | 100 |
| 13vPnC Group 2 (Term Infant) Term infant participants (GA \>=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-Year Follow-up | Lost to Follow-up | 4 | 0 |
| 1-Year Follow-up | No Longer Willing to Participate | 7 | 9 |
| 2-Year Follow-up | No Longer Met Eligibility Criteria | 2 | 2 |
| 2-Year Follow-up | No Longer Willing to Participate | 5 | 6 |
| After Infant Series | Lost to Follow-up | 1 | 2 |
| After Infant Series | No Longer Met Eligibility Criteria | 0 | 1 |
Baseline characteristics
| Characteristic | 13vPnC Group 1 (Preterm Infant) | 13vPnC Group 2 (Term Infant) | Total |
|---|---|---|---|
| Age, Continuous | 1.8 months STANDARD_DEVIATION 0.6 | 1.5 months STANDARD_DEVIATION 0.5 | 1.7 months STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 48 Participants | 55 Participants | 103 Participants |
| Sex: Female, Male Male | 52 Participants | 45 Participants | 97 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 | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 98 / 100 | 99 / 100 | 13 / 100 | 11 / 100 | 93 / 99 | 92 / 97 | 2 / 99 | 0 / 97 | 1 / 88 | 1 / 88 |
| serious Total, serious adverse events | 14 / 100 | 5 / 100 | 8 / 100 | 9 / 100 | 2 / 99 | 1 / 97 | 13 / 99 | 8 / 97 | 6 / 88 | 8 / 88 |
Outcome results
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n=99, 97) | 0.86 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n=99, 97) | 7.48 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n=99, 97) | 1.26 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n=99, 97) | 1.96 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n=99, 97) | 0.83 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n=99, 97) | 1.93 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n=99, 97) | 0.56 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n=99, 97) | 1.26 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n=98, 97) | 1.22 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n=99, 97) | 2.14 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n=99, 97) | 2.21 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n=99, 97) | 2.85 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n=99, 97) | 0.73 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n=99, 97) | 3.35 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n=99, 97) | 2.46 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n=99, 97) | 1.30 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n=99, 97) | 1.70 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n=99, 97) | 6.08 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n=99, 97) | 1.93 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n=99, 97) | 3.05 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n=99, 97) | 1.36 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n=99, 97) | 1.79 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n=99, 97) | 0.86 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n=99, 97) | 1.03 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n=99, 97) | 3.02 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n=98, 97) | 2.01 mcg/mL |
Comparison: Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.62, 1.02]
Comparison: Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.38, 0.82]
Comparison: Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.59, 0.93]
Comparison: Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.92, 1.65]
Comparison: Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.8, 1.25]
Comparison: Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.58, 0.9]
Comparison: Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.47, 0.86]
Comparison: Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.55, 0.89]
Comparison: Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.77, 1.19]
Comparison: Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.4, 0.72]
Comparison: Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.45, 0.82]
Comparison: Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.57, 0.88]
Comparison: Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.68, 1.07]
Primary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 9V (n=99, 97) | 96.97 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 1 (n=99, 97) | 93.94 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 18C (n=99, 97) | 96.97 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 3 (n=99, 97) | 85.86 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 6B (n=99, 97) | 72.73 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 5 (n=99, 97) | 71.72 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 19F (n=99, 97) | 98.99 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 6A (n=98, 97) | 82.65 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 14 (n=99, 97) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 7F (n=99, 97) | 98.99 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 23F (n=99, 97 ) | 85.86 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 19A (n=99, 97) | 98.99 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 4 (n=99, 97) | 96.97 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 19A (n=99, 97) | 98.97 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 4 (n=99, 97) | 98.97 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 6B (n=99, 97) | 87.63 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 9V (n=99, 97) | 96.91 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 14 (n=99, 97) | 97.94 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 18C (n=99, 97) | 94.85 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 19F (n=99, 97) | 98.97 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 23F (n=99, 97 ) | 92.78 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 1 (n=99, 97) | 95.88 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 3 (n=99, 97) | 90.72 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 5 (n=99, 97) | 90.72 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 6A (n=98, 97) | 94.85 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series | 7F (n=99, 97) | 98.97 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-7.65, 2.88]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-26.4, -3.21]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-5.84, 6.05]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-1.71, 7.25]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.09, 8.89]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.54, 4.68]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-16.19, 1.89]
Comparison: Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-9.07, 4.86]
Comparison: Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-14.4, 4.39]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-30.1, -7.16]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-21.66, -3.26]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.54, 4.68]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.54, 4.68]
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 1 of the infant series
Population: Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Any (n=94, 88) | 48.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Mild (n=93, 88) | 46.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Moderate (n=90, 85) | 17.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Any (n=94, 89) | 39.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Mild (n=91, 89) | 37.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Moderate (n=91, 85) | 8.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Any (n=92, 87) | 33.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Mild (n=90, 87) | 32.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Moderate (n=88, 85) | 3.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Moderate (n=88, 85) | 4.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Any (n=94, 88) | 42.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Moderate (n=91, 85) | 8.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Mild (n=93, 88) | 31.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Mild (n=90, 87) | 28.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Moderate (n=90, 85) | 16.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Tenderness- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Any (n=94, 89) | 29.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Redness- Any (n=92, 87) | 29.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series | Swelling- Mild (n=91, 89) | 28.1 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 2 of the infant series
Population: Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Any (n=85, 88 ) | 48.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Mild (n=85, 84) | 43.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Moderate (n=77, 83) | 14.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Any (n=84, 82) | 35.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Mild (n=83, 82) | 33.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Moderate (n=75, 76) | 8.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Severe (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Any (n=82, 82) | 28.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Mild (n=82, 82) | 28.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Moderate (n=73, 76) | 2.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Severe (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Moderate (n=73, 76) | 2.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Any (n=85, 88 ) | 38.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Moderate (n=75, 76) | 2.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Mild (n=85, 84) | 31.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Mild (n=82, 82) | 37.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Moderate (n=77, 83) | 15.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Severe (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Tenderness- Severe (n=73, 77) | 1.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Severe (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Any (n=84, 82) | 42.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Redness- Any (n=82, 82) | 40.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series | Swelling- Mild (n=83, 82) | 42.7 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 3 of the infant series
Population: Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Any (n=82, 84) | 39.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Mild (n=81, 84) | 35.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Moderate (n=75, 78) | 9.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Any (n=83, 85) | 30.1 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Mild (n=82, 85) | 26.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Moderate (n=75, 79) | 5.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Any (n=82, 87) | 32.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Mild (n=82, 87) | 32.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Moderate (n=74, 79) | 1.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Moderate (n=74, 79) | 3.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Any (n=82, 84) | 28.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Moderate (n=75, 79) | 5.1 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Mild (n=81, 84) | 26.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Mild (n=82, 87) | 46.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Moderate (n=75, 78) | 5.1 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Tenderness- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Severe (n=73, 77) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Any (n=83, 85) | 41.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Redness- Any (n=82, 87) | 46.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series | Swelling- Mild (n=82, 85) | 41.2 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 7 days after the toddler dose
Population: Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Any (n=86, 85) | 69.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Mild (n=86, 85) | 66.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Moderate (n=77, 70) | 20.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Severe (n=74, 69) | 2.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Any (n=81, 80) | 43.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Mild (n=80, 79) | 38.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Moderate (n=76, 74) | 13.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Severe (n=74, 69) | 1.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Any (n=85, 83) | 51.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Mild (n=85, 83) | 51.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Moderate (n=75, 75) | 6.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Severe (n=74, 69) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Moderate (n=75, 75) | 10.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Any (n=86, 85) | 55.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Moderate (n=76, 74) | 9.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Mild (n=86, 85) | 51.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Mild (n=85, 83) | 48.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Moderate (n=77, 70) | 11.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Severe (n=74, 69) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Tenderness- Severe (n=74, 69) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Severe (n=74, 69) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Any (n=81, 80) | 35.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Redness- Any (n=85, 83) | 49.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose | Swelling- Mild (n=80, 79) | 32.9 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 1 of the infant series
Population: Safety population for Dose 1 infant series: all participants who received 13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep- Any (n=95, 97) | 84.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Mild (n=96, 93) | 60.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >=38 degrees C (n=86, 88) | 11.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >=38 degrees C, =<39 degrees C (n=86, 88) | 10.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >=39 degrees C, =<40 degrees C (n=86, 85) | 1.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >40 degrees C (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Any (n=92, 89) | 60.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Mild (n=91, 88) | 54.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Moderate (n=88, 87) | 20.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Severe (n=86, 85) | 1.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Moderate (n=87, 88) | 29.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Severe (n=86, 85) | 2.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep- Mild (n=93, 95) | 77.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep-Moderate (n=92, 91 | 43.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep- Severe (n=86, 85) | 8.1 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Use of Antipyretic Medication (n=90, 90) | 24.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Any (n=96, 95) | 67.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep- Mild (n=93, 95) | 69.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Any (n=96, 95) | 69.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Severe (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Mild (n=96, 93) | 61.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >=38 degrees C (n=86, 88) | 13.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep- Severe (n=86, 85) | 5.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >=38 degrees C, =<39 degrees C (n=86, 88) | 13.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Moderate (n=87, 88) | 30.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >=39 degrees C, =<40 degrees C (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep-Moderate (n=92, 91 | 47.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Fever >40 degrees C (n=86, 85) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Increased Sleep- Severe (n=86, 85) | 2.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Any (n=92, 89) | 41.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Irritability or Decreased Sleep- Any (n=95, 97) | 82.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Mild (n=91, 88) | 35.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Use of Antipyretic Medication (n=90, 90) | 24.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series | Decreased Appetite- Moderate (n=88, 87) | 17.2 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 2 of the infant series
Population: Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Moderate (n=78, 78) | 34.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep-Moderate (n=85, 86 | 64.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Severe (n=73, 76) | 2.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Any (n=85, 89 ) | 74.1 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep- Any (n=95, 95) | 89.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >=38 degrees C (n=79, 79) | 27.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep- Severe (n=74, 76) | 17.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >=38 degrees C, =<39 degrees C (n=79, 79) | 27.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Severe (n=73, 76) | 1.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >=39 degrees C, =<40 degrees C (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Use of Antipyretic Medication (n=84, 83) | 48.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >40 degrees C (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep- Mild (n=90, 92) | 81.1 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Any (n=89, 84) | 61.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Mild (n=83, 88) | 69.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Mild (n=88, 84) | 55.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Moderate (n=79, 78) | 25.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Mild (n=88, 84) | 41.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Moderate (n=79, 78) | 19.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Severe (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep- Any (n=95, 95) | 77.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep- Mild (n=90, 92) | 71.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep-Moderate (n=85, 86 | 44.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Irritability or Decreased Sleep- Severe (n=74, 76) | 2.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Use of Antipyretic Medication (n=84, 83) | 45.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Mild (n=83, 88) | 59.1 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Moderate (n=78, 78) | 29.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Severe (n=73, 76) | 1.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >=38 degrees C (n=79, 79) | 31.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >=38 degrees C, =<39 degrees C (n=79, 79) | 30.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >=39 degrees C, =<40 degrees C (n=73, 76) | 1.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Fever >40 degrees C (n=73, 76) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Decreased Appetite- Any (n=89, 84) | 46.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series | Increased Sleep- Any (n=85, 89 ) | 64.0 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 3 of the infant series
Population: Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Moderate (n=74, 79) | 17.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Severe (n=74, 77) | 1.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Any (n=88, 88 ) | 52.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >=38 degrees C (n=79, 81) | 27.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Moderate (n=77, 80) | 16.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Mild (n=88, 87) | 48.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Severe (n=73, 77) | 1.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep- Any (n=92, 95) | 79.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep- Mild (n=90, 91) | 72.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep-Moderate (n=80,87) | 33.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep- Severe (n=74, 78) | 6.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Use of Antipyretic Medication (n=84, 81) | 40.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >=38 degrees C, =<39 degrees C (n=78, 81) | 26.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >=39 degrees C, =<40 degrees C (n=75, 78) | 1.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >40 degrees C (n=74, 77) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Any (n=82, 84) | 48.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Mild (n=82, 84) | 36.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep- Any (n=92, 95) | 81.1 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Use of Antipyretic Medication (n=84, 81) | 38.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Severe (n=74, 77) | 1.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep- Mild (n=90, 91) | 74.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >=38 degrees C (n=79, 81) | 30.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >=38 degrees C, =<39 degrees C (n=78, 81) | 30.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Any (n=82, 84) | 47.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep-Moderate (n=80,87) | 35.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Any (n=88, 88 ) | 58.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >40 degrees C (n=74, 77) | 0.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Mild (n=88, 87) | 51.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Mild (n=82, 84) | 46.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Decreased Appetite- Moderate (n=74, 79) | 16.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Moderate (n=77, 80) | 20.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Irritability or Decreased Sleep- Severe (n=74, 78) | 6.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Increased Sleep- Severe (n=73, 77) | 1.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series | Fever >=39 degrees C, =<40 degrees C (n=75, 78) | 2.6 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Time frame: Within 7 days after the toddler dose
Population: Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >=39 degrees C, =<40 degrees C (n=74, 71) | 1.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >40 degrees C (n=74, 70) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Any (n=87, 86) | 57.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Mild (n=86, 84) | 50.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Moderate (n=78, 73) | 25.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Mild (n=82, 84) | 53.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Moderate (n=76, 74) | 18.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Severe (n=75, 69) | 1.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Any (n=83, 86 ) | 57.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Severe (n=74, 70) | 0.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep- Any (n=90, 91) | 84.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep- Mild (n=90, 89) | 74.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep-Moderate (n=78,80) | 44.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep- Severe (n=76, 69) | 6.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Use of Antipyretic Medication (n=82, 79) | 48.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >=38 degrees C (n= 80, 78) | 28.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >=38 degrees C, =<39 degrees C (n=80, 77) | 27.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep-Moderate (n=78,80) | 45.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >=39 degrees C, =<40 degrees C (n=74, 71) | 4.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >=38 degrees C, =<39 degrees C (n=80, 77) | 42.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >40 degrees C (n=74, 70) | 1.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Severe (n=74, 70) | 2.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Any (n=87, 86) | 60.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep- Severe (n=76, 69) | 4.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Mild (n=86, 84) | 56.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep- Any (n=90, 91) | 80.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Any (n=83, 86 ) | 65.1 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Fever >=38 degrees C (n= 80, 78) | 43.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Mild (n=82, 84) | 59.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Irritability or Decreased Sleep- Mild (n=90, 89) | 76.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Increased Sleep- Moderate (n=76, 74) | 24.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Moderate (n=78, 73) | 23.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Use of Antipyretic Medication (n=82, 79) | 50.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose | Decreased Appetite- Severe (n=75, 69) | 1.4 percentage of participants |
Primary
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: 1 month after toddler dose up to 1-year follow-up
Population: Safety population for 1-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose | AEs | 15.2 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose | SAEs | 13.1 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose | AEs | 8.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose | SAEs | 8.2 percentage of participants |
Comparison: AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.183Fisher Exact
Comparison: SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.357Fisher Exact
Primary
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: 1-year follow-up after toddler dose to 2-year follow-up after toddler dose
Population: Safety population for 2-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose | AEs | 8.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose | SAEs | 6.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose | AEs | 10.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose | SAEs | 9.1 percentage of participants |
Comparison: AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.794Fisher Exact
Comparison: SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.782Fisher Exact
Primary
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: 1 Month after Dose 3 of the infant series up to toddler dose
Population: Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series | AEs | 18.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series | SAEs | 8.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series | AEs | 15.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series | SAEs | 9.0 percentage of participants |
Comparison: AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.704Fisher Exact
Comparison: SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: >0.99Fisher Exact
Primary
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Dose 1 up to 1 month after Dose 3 (infant series)
Population: Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series | AEs | 59.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series | SAEs | 14.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series | AEs | 55.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series | SAEs | 5.0 percentage of participants |
Comparison: AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.668Fisher Exact
Comparison: SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.051Fisher Exact
Primary
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Toddler dose up to 1 Month after toddler dose
Population: Safety population for toddler dose included all participants who received 13vPnC toddler dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose | AEs | 31.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose | SAEs | 2.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose | AEs | 26.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose | SAEs | 1.0 percentage of participants |
Comparison: AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: 0.531Fisher Exact
Comparison: SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.p-value: >0.99Fisher Exact
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: 1 Month After Infant Series
Population: Evaluable Infant Immunogenicity Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 7F (n=24, 50, 25) | 2.43 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 3 (n=24, 50, 25) | 1.28 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 19F (n=24, 50, 25) | 2.46 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 9V (n=24, 50, 25) | 1.44 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 1 (n=24, 50, 25) | 1.56 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 23F (n=24, 50, 25) | 1.38 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 4 (n=24, 50, 25) | 2.50 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 6B (n=24, 50, 25) | 1.23 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 6A (n=24, 49, 25) | 1.74 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 14 (n=24, 50, 25) | 8.95 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 19A (n=24, 50, 25) | 3.43 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 5 (n=24, 50, 25) | 0.85 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 18C (n=24, 50, 25) | 2.58 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 23F (n=24, 50, 25) | 0.65 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 4 (n=24, 50, 25) | 1.86 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 6B (n=24, 50, 25) | 0.61 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 9V (n=24, 50, 25) | 1.25 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 14 (n=24, 50, 25) | 7.13 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 18C (n=24, 50, 25) | 1.78 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 19F (n=24, 50, 25) | 2.06 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 1 (n=24, 50, 25) | 1.21 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 3 (n=24, 50, 25) | 0.75 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 5 (n=24, 50, 25) | 0.50 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 6A (n=24, 49, 25) | 1.15 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 7F (n=24, 50, 25) | 1.99 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 19A (n=24, 50, 25) | 2.60 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 3 (n=24, 50, 25) | 0.67 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 14 (n=24, 50, 25) | 6.95 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 7F (n=24, 50, 25) | 2.18 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 5 (n=24, 50, 25) | 0.46 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 9V (n=24, 50, 25) | 1.14 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 4 (n=24, 50, 25) | 1.73 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 6A (n=24, 49, 25) | 0.98 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 23F (n=24, 50, 25) | 0.95 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 19F (n=24, 50, 25) | 2.28 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 6B (n=24, 50, 25) | 0.62 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 1 (n=24, 50, 25) | 1.10 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 18C (n=24, 50, 25) | 1.72 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C | 19A (n=24, 50, 25) | 2.88 mcg/mL |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: 1 Month After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 9V (n=86, 87) | 2.30 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 1 (n=86, 87) | 3.32 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 18C (n=86, 87) | 2.37 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 3 (n=85, 87) | 0.52 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 6B (n=86, 87) | 4.42 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 5 (n=86, 87) | 2.63 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 19F (n=86, 87) | 7.38 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 6A (n=86, 87) | 5.64 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 14 (n=86, 87) | 9.24 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 7F (n=86, 87) | 4.25 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 23F (n=86, 87) | 2.45 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 19A (n=86, 87) | 5.57 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 4 (n= 86, 87) | 2.57 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 19A (n=86, 87) | 8.84 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 4 (n= 86, 87) | 3.97 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 6B (n=86, 87) | 7.27 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 9V (n=86, 87) | 3.06 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 14 (n=86, 87) | 11.02 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 18C (n=86, 87) | 2.81 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 19F (n=86, 87) | 11.67 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 23F (n=86, 87) | 4.03 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 1 (n=86, 87) | 4.09 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 3 (n=85, 87) | 0.57 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 5 (n=86, 87) | 3.72 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 6A (n=86, 87) | 7.84 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose | 7F (n=86, 87) | 5.13 mcg/mL |
Comparison: Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.51, 0.82]
Comparison: Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.47, 0.79]
Comparison: Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.61, 0.93]
Comparison: Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.66, 1.07]
Comparison: Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.66, 1.08]
Comparison: Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.48, 0.83]
Comparison: Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.46, 0.79]
Comparison: Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.64, 1.03]
Comparison: Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.73, 1.15]
Comparison: Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.58, 0.87]
Comparison: Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.57, 0.9]
Comparison: Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.69, 1]
Comparison: Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.49, 0.81]
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: 1 Month After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 7F (n=21, 45, 20) | 5.29 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 3 (n=21, 44, 20) | 0.88 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19F (n=21, 45, 20) | 10.45 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 9V (n= 21, 45, 20) | 2.99 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 (n=21, 45, 20) | 4.78 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 23F (n=21, 45, 20) | 3.57 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 4 (n= 21, 45, 20) | 3.58 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6B (n= 21, 45, 20) | 6.28 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6A (n=21, 45, 20) | 6.95 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 14 (n=21, 45, 20) | 13.20 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19A (n=21, 45, 20) | 8.63 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 5 (n=21, 45, 20) | 3.41 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 18C (n=21, 45, 20) | 3.71 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 23F (n=21, 45, 20) | 2.41 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 4 (n= 21, 45, 20) | 2.87 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6B (n= 21, 45, 20) | 4.28 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 9V (n= 21, 45, 20) | 2.23 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 14 (n=21, 45, 20) | 8.84 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 18C (n=21, 45, 20) | 2.40 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19F (n=21, 45, 20) | 7.39 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 (n=21, 45, 20) | 3.31 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 3 (n=21, 44, 20) | 0.51 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 5 (n=21, 45, 20) | 2.66 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6A (n=21, 45, 20) | 5.81 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 7F (n=21, 45, 20) | 4.09 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19A (n=21, 45, 20) | 5.28 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 3 (n=21, 44, 20) | 0.31 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 14 (n=21, 45, 20) | 7.01 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 7F (n=21, 45, 20) | 3.69 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 5 (n=21, 45, 20) | 1.95 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 9V (n= 21, 45, 20) | 1.88 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 4 (n= 21, 45, 20) | 1.41 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6A (n=21, 45, 20) | 4.23 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 23F (n=21, 45, 20) | 1.71 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19F (n=21, 45, 20) | 5.12 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6B (n= 21, 45, 20) | 3.29 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 (n=21, 45, 20) | 2.28 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 18C (n=21, 45, 20) | 1.45 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19A (n=21, 45, 20) | 3.96 mcg/mL |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: Before Toddler Dose (pre-vaccination)
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 9V (n= 85, 85) | 0.39 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 1 (n=85, 85) | 0.39 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 18C (n=85, 85) | 0.32 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 3 (n=84, 84) | 0.07 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 6B (n= 82, 85) | 0.48 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 5 (n=82, 85) | 0.74 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 19F (n=85, 85) | 0.68 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 6A (n=85, 85) | 0.54 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 14 (n= 85, 85) | 2.02 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 7F (n=85, 85) | 0.72 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 23F (n=81, 83) | 0.24 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 19A (n=85, 85) | 0.86 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 4 (n= 85, 85) | 0.31 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 19A (n=85, 85) | 1.57 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 4 (n= 85, 85) | 0.41 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 6B (n= 82, 85) | 0.94 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 9V (n= 85, 85) | 0.62 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 14 (n= 85, 85) | 2.36 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 18C (n=85, 85) | 0.30 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 19F (n=85, 85) | 0.93 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 23F (n=81, 83) | 0.40 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 1 (n=85, 85) | 0.41 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 3 (n=84, 84) | 0.11 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 5 (n=82, 85) | 1.06 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 6A (n=85, 85) | 1.01 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose | 7F (n=85, 85) | 0.84 mcg/mL |
Comparison: Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.95% CI: [0.6, 0.97]
Comparison: Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.39, 0.66]
Comparison: Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.51, 0.8]
Comparison: Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.95% CI: [0.66, 1.12]
Comparison: Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.95% CI: [0.85, 1.32]
Comparison: Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.95% CI: [0.58, 0.92]
Comparison: Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.43, 0.83]
Comparison: Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.77, 1.2]
Comparison: Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.41, 0.87]
Comparison: Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.56, 0.88]
Comparison: Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.41, 0.7]
Comparison: Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.71, 1.03]
Comparison: Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.42, 0.72]
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: Before Toddler Dose (pre-vaccination)
Population: Evaluable Toddler Immunogenicity Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 4 (n= 20, 44, 21) | 0.37 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 6B (n= 20, 42, 20) | 0.59 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 9V (n= 20, 44, 21) | 0.43 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 14 (n=20, 44, 21) | 2.48 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 18C (n=20, 44, 21) | 0.35 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 19F (n=20, 44, 21) | 0.96 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 23F (n=20, 41, 20) | 0.31 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 1 (n=20, 44, 21) | 0.37 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 3 (n=20, 44, 20) | 0.13 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 5 (n=19, 43, 20) | 0.75 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 6A (n=20, 44, 21) | 0.66 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 7F (n=20, 44, 21) | 0.71 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 19A (n=20, 44, 21) | 1.20 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 3 (n=20, 44, 20) | 0.06 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 4 (n= 20, 44, 21) | 0.28 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 6A (n=20, 44, 21) | 0.49 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 23F (n=20, 41, 20) | 0.21 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 6B (n= 20, 42, 20) | 0.42 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 19F (n=20, 44, 21) | 0.58 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 19A (n=20, 44, 21) | 0.72 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 5 (n=19, 43, 20) | 0.71 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 9V (n= 20, 44, 21) | 0.36 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 1 (n=20, 44, 21) | 0.39 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 18C (n=20, 44, 21) | 0.30 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 14 (n=20, 44, 21) | 1.83 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 7F (n=20, 44, 21) | 0.64 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 14 (n=20, 44, 21) | 2.04 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 18C (n=20, 44, 21) | 0.34 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 19F (n=20, 44, 21) | 0.67 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 6A (n=20, 44, 21) | 0.55 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 23F (n=20, 41, 20) | 0.24 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 1 (n=20, 44, 21) | 0.42 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 4 (n= 20, 44, 21) | 0.32 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 7F (n=20, 44, 21) | 0.91 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 3 (n=20, 44, 20) | 0.05 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 6B (n= 20, 42, 20) | 0.49 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 9V (n= 20, 44, 21) | 0.44 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 5 (n=19, 43, 20) | 0.81 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C | 19A (n=20, 44, 21) | 0.92 mcg/mL |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 1 Year After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 9V (n=80, 80) | 0.61 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 1 (n=78, 80) | 0.40 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 18C (n=80, 79) | 0.33 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 3 (n=78, 78) | 0.13 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 6B (n=80, 80) | 1.26 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 5 (n=79, 78) | 1.10 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 19F (n=80, 79) | 0.96 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 6A (n=80, 79) | 1.08 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 14 (n=79, 80) | 1.43 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 7F (n=79, 80) | 0.68 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 23F (n=79, 80) | 0.59 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 19A (n=80, 80) | 1.61 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 4 (n= 80, 79) | 0.30 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 19A (n=80, 80) | 3.16 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 4 (n= 80, 79) | 0.37 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 6B (n=80, 80) | 2.01 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 9V (n=80, 80) | 0.98 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 14 (n=79, 80) | 1.73 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 18C (n=80, 79) | 0.66 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 19F (n=80, 79) | 1.78 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 23F (n=79, 80) | 1.24 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 1 (n=78, 80) | 0.53 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 3 (n=78, 78) | 0.22 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 5 (n=79, 78) | 1.63 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 6A (n=80, 79) | 1.59 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose | 7F (n=79, 80) | 0.83 mcg/mL |
Comparison: Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.63, 1.04]
Comparison: Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.48, 0.83]
Comparison: Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.46, 0.84]
Comparison: Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.61, 1.12]
Comparison: Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.37, 0.67]
Comparison: Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.4, 0.72]
Comparison: Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.35, 0.64]
Comparison: Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.61, 0.94]
Comparison: Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.39, 0.9]
Comparison: Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.52, 0.87]
Comparison: Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.52, 0.88]
Comparison: Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.67, 1.02]
Comparison: Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.36, 0.72]
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 1 Year After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 7F (n=18, 42, 19) | 0.65 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 3 (n=18, 41, 19) | 0.17 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 19F (n=18, 43, 19) | 1.27 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 9V (n=18, 43, 19) | 0.59 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 1 (n=18, 41, 19) | 0.39 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 23F (n=18, 42, 19) | 0.79 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 4 (n=18, 43, 19) | 0.30 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 6B (n=18, 43, 19) | 1.49 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 6A (n=18, 43, 19) | 1.17 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 14 (n=18, 42, 19) | 1.37 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 19A (n=18, 43, 19) | 2.12 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 5 (n=18, 42, 19) | 0.87 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 18C (n=18, 43, 19) | 0.39 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 23F (n=18, 42, 19) | 0.54 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 4 (n=18, 43, 19) | 0.29 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 6B (n=18, 43, 19) | 1.28 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 9V (n=18, 43, 19) | 0.56 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 14 (n=18, 42, 19) | 1.38 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 18C (n=18, 43, 19) | 0.31 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 19F (n=18, 43, 19) | 0.89 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 1 (n=18, 41, 19) | 0.38 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 3 (n=18, 41, 19) | 0.12 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 5 (n=18, 42, 19) | 1.24 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 6A (n=18, 43, 19) | 1.05 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 7F (n=18, 42, 19) | 0.65 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 19A (n=18, 43, 19) | 1.50 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 3 (n=18, 41, 19) | 0.11 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 14 (n=18, 42, 19) | 1.62 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 7F (n=18, 42, 19) | 0.81 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 5 (n=18, 42, 19) | 1.05 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 9V (n=18, 43, 19) | 0.80 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 4 (n=18, 43, 19) | 0.32 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 6A (n=18, 43, 19) | 1.07 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 23F (n=18, 42, 19) | 0.53 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 19F (n=18, 43, 19) | 0.86 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 6B (n=18, 43, 19) | 1.06 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 1 (n=18, 41, 19) | 0.45 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 18C (n=18, 43, 19) | 0.32 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C | 19A (n=18, 43, 19) | 1.45 mcg/mL |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 2 Years After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 6B (n=70, 70) | 1.44 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 1 (n=70, 69) | 0.32 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 14 (n=70, 71) | 1.06 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 3 (n=65, 63) | 0.17 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 4 (n=70, 71) | 0.19 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 5 (n=69, 69) | 1.34 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 18C (n=69, 71) | 0.32 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 6A (n=71, 71) | 1.41 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 9V (n=71, 70) | 0.74 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 7F (n=71, 70) | 0.60 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 19F (n=71, 70) | 1.10 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 19A (n=71, 71) | 2.33 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 23F (n=71, 71) | 1.03 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 19A (n=71, 71) | 4.36 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 4 (n=70, 71) | 0.24 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 6B (n=70, 70) | 2.70 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 9V (n=71, 70) | 0.99 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 14 (n=70, 71) | 1.37 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 18C (n=69, 71) | 0.57 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 23F (n=71, 71) | 1.83 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 1 (n=70, 69) | 0.39 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 3 (n=65, 63) | 0.27 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 5 (n=69, 69) | 1.97 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 6A (n=71, 71) | 2.10 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 7F (n=71, 70) | 0.67 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose | 19F (n=71, 70) | 2.43 mcg/mL |
Comparison: Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.61, 1.03]
Comparison: Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.38, 0.76]
Comparison: Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.54, 1.03]
Comparison: Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.51, 1.17]
Comparison: Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.4, 0.78]
Comparison: Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.29, 0.71]
Comparison: Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.38, 0.83]
Comparison: Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.63, 1.07]
Comparison: Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.39, 1.11]
Comparison: Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.5, 0.92]
Comparison: Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.47, 0.95]
Comparison: Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.7, 1.13]
Comparison: Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.95% CI: [0.37, 0.78]
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 2 Years After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 7F (n=17, 36, 18) | 0.61 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 3 (n=16, 33, 16) | 0.20 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 19F (n=17, 36, 18) | 1.53 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 9V (n=17, 36, 18) | 0.68 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 1 (n=17, 35, 18) | 0.32 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 23F (n=17, 36, 18) | 1.14 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 4 (n=17, 35, 18) | 0.17 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 6B (n=17, 35, 18) | 1.39 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 6A (n=17, 36, 18) | 1.32 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 14 (n=17, 35, 18) | 1.27 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 19A (n=17, 36, 18) | 3.04 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 5 (n=17, 35, 17) | 1.18 mcg/mL |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 18C (n=16, 35, 18) | 0.34 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 23F (n=17, 36, 18) | 1.41 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 4 (n=17, 35, 18) | 0.19 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 6B (n=17, 35, 18) | 1.81 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 9V (n=17, 36, 18) | 0.83 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 14 (n=17, 35, 18) | 1.02 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 18C (n=16, 35, 18) | 0.35 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 19F (n=17, 36, 18) | 0.93 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 1 (n=17, 35, 18) | 0.35 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 3 (n=16, 33, 16) | 0.19 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 5 (n=17, 35, 17) | 1.67 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 6A (n=17, 36, 18) | 1.58 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 7F (n=17, 36, 18) | 0.68 mcg/mL |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 19A (n=17, 36, 18) | 2.46 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 3 (n=16, 33, 16) | 0.14 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 14 (n=17, 35, 18) | 0.96 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 7F (n=17, 36, 18) | 0.46 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 5 (n=17, 35, 17) | 0.97 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 9V (n=17, 36, 18) | 0.63 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 4 (n=17, 35, 18) | 0.21 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 6A (n=17, 36, 18) | 1.20 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 23F (n=17, 36, 18) | 0.50 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 19F (n=17, 36, 18) | 1.13 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 6B (n=17, 35, 18) | 0.96 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 1 (n=17, 35, 18) | 0.26 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 18C (n=16, 35, 18) | 0.26 mcg/mL |
| 13vPnC Group 1C | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C | 19A (n=17, 36, 18) | 1.64 mcg/mL |
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.
Time frame: Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 9V (n=83, 85) | 5.85 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 1 (n=83, 85) | 8.41 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 18C (n=83, 85) | 7.36 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 3 (n=81, 84) | 7.61 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 6B (n=80, 85) | 9.46 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 5 (n=80, 85) | 3.47 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 19F (n=83, 85) | 10.82 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 6A (n=83, 85) | 10.52 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 14 (n=83, 85) | 4.50 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 7F (n=83, 85) | 5.81 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 23F (n=79, 83) | 10.11 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 19A (n=83, 85) | 6.45 fold rise |
| 13vPnC Group 1 (Preterm Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 4 (n= 83, 85) | 8.14 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 19A (n=83, 85) | 5.59 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 4 (n= 83, 85) | 9.61 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 6B (n=80, 85) | 7.61 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 9V (n=83, 85) | 4.92 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 14 (n=83, 85) | 4.65 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 18C (n=83, 85) | 9.14 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 19F (n=83, 85) | 12.31 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 23F (n=79, 83) | 10.15 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 1 (n=83, 85) | 9.98 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 3 (n=81, 84) | 5.23 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 5 (n=80, 85) | 3.46 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 6A (n=83, 85) | 7.72 fold rise |
| 13vPnC Group 2 (Term Infant) | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose | 7F (n=83, 85) | 6.07 fold rise |
Comparison: Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.63, 1.14]
Comparison: Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.95, 1.62]
Comparison: Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.96, 1.47]
Comparison: Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.74, 1.26]
Comparison: Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.63, 1.02]
Comparison: Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.65, 1.19]
Comparison: Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.95% CI: [0.74, 1.33]
Comparison: Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.95% CI: [0.64, 1.11]
Comparison: Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [1.03, 2.05]
Comparison: Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.81, 1.24]
Comparison: Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [1.02, 1.82]
Comparison: Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.78, 1.18]
Comparison: Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).95% CI: [0.88, 1.52]
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
Time frame: 1 month after the toddler dose
Population: Evaluable Toddler Immunogenicity Population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 9V (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 1 (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 18C (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 3 (n=85, 87) | 70.59 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 6B (n=86, 87) | 97.67 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 5 (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 19F (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 6A (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 14 (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 7F (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 23F (n=86, 87) | 98.84 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 19A (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 4 (n= 86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 19A (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 4 (n= 86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 6B (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 9V (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 14 (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 18C (n=86, 87) | 98.85 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 19F (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 23F (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 1 (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 3 (n=85, 87) | 79.31 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 5 (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 6A (n=86, 87) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose | 7F (n=86, 87) | 100.00 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-8.15, 1.96]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-3.13, 6.24]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-6.32, 3.1]
Comparison: Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-21.93, 4.42]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.95% CI: [-4.25, 4.31]
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the toddler dose
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 7F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 3 (n=21, 44, 20) | 95.24 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 9V (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 23F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 4 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6B (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6A (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 14 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19A (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 5 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 18C (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 23F (n=21, 45, 20) | 97.78 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 4 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6B (n=21, 45, 20) | 95.56 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 9V (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 14 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 18C (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 3 (n=21, 44, 20) | 68.18 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 5 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6A (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 7F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19A (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 3 (n=21, 44, 20) | 50.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 14 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 7F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 5 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 9V (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 4 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6A (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 23F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19F (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 6B (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 1 (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 18C (n=21, 45, 20) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C | 19A (n=21, 45, 20) | 100.00 percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: 1 Month After Infant Series
Population: Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 7F (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 3 (n=24, 50, 25) | 87.50 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 19F (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 9V (n=24, 50, 25) | 95.83 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 1 (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 23F (n=24, 50, 25) | 91.67 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 4 (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 6B (n=24, 50, 25) | 79.17 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 6A (n=24, 49, 25) | 95.83 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 14 (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 19A (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 5 (n=24, 50, 25) | 79.17 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 18C (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 23F (n=24, 50, 25) | 80.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 4 (n=24, 50, 25) | 96.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 6B (n=24, 50, 25) | 72.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 9V (n=24, 50, 25) | 98.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 14 (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 18C (n=24, 50, 25) | 94.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 19F (n=24, 50, 25) | 98.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 1 (n=24, 50, 25) | 92.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 3 (n=24, 50, 25) | 86.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 5 (n=24, 50, 25) | 66.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 6A (n=24, 49, 25) | 81.63 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 7F (n=24, 50, 25) | 98.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 19A (n=24, 50, 25) | 98.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 3 (n=24, 50, 25) | 84.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 14 (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 7F (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 5 (n=24, 50, 25) | 76.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 9V (n=24, 50, 25) | 96.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 4 (n=24, 50, 25) | 96.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 6A (n=24, 49, 25) | 72.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 23F (n=24, 50, 25) | 92.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 19F (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 6B (n=24, 50, 25) | 68.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 1 (n=24, 50, 25) | 92.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 18C (n=24, 50, 25) | 100.00 percentage of participants |
| 13vPnC Group 1C | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C | 19A (n=24, 50, 25) | 100.00 percentage of participants |
Secondary
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Time frame: 1 Month After Infant Series
Population: Evaluable Infant Immunogenicity Population. Here 'n' signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 9V (n= 54, 60) | 64.81 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 1 (n= 88, 87) | 40.91 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 18C (n= 56, 63) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 3 (n=83, 86) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 6B (n= 51, 61) | 90.20 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 5 (n= 83, 85) | 67.47 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 19F (n= 55, 58) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 6A (n= 88, 88) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 14 (n= 55, 66) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 7F (n= 93, 86) | 97.85 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 23F (n= 55, 60) | 98.18 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 19A (n= 92, 86) | 98.91 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 4 (n= 58, 62) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 19A (n= 92, 86) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 4 (n= 58, 62) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 6B (n= 51, 61) | 95.08 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 9V (n= 54, 60) | 71.67 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 14 (n= 55, 66) | 96.97 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 18C (n= 56, 63) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 19F (n= 55, 58) | 96.55 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 23F (n= 55, 60) | 96.67 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 1 (n= 88, 87) | 51.72 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 3 (n=83, 86) | 95.35 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 5 (n= 83, 85) | 83.53 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 6A (n= 88, 88) | 97.73 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | 7F (n= 93, 86) | 100.00 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-6.33, 5.99]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-16.87, 5.39]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-24.28, 10.67]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-3.68, 10.57]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-6.57, 5.88]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-3.32, 11.91]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-6.73, 9.94]
Comparison: Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-25.51, 4.34]
Comparison: Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [0.04, 11.48]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-29.15, -2.6]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-1.96, 7.97]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-7.55, 2.1]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-5.96, 3.18]
Secondary
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Time frame: 1 Month After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 9V (n= 60, 58) | 95.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 1 (n= 80, 83) | 87.50 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 18C (n= 62, 63) | 98.39 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 3 (n=78, 79) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 6B (n= 64, 61) | 98.44 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 5 (n= 80, 83) | 96.25 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 19F (n= 61, 62) | 88.52 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 6A (n=78, 74) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 14 (n= 62, 62) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 7F (n= 81, 82) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 23F (n= 65, 63) | 98.46 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 19A (n= 81, 82) | 100.00 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 4 (n= 67, 61) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 19A (n= 81, 82) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 4 (n= 67, 61) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 6B (n= 64, 61) | 98.36 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 9V (n= 60, 58) | 96.55 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 14 (n= 62, 62) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 18C (n= 62, 63) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 19F (n= 61, 62) | 95.16 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 23F (n= 65, 63) | 98.41 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 1 (n= 80, 83) | 93.98 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 3 (n=78, 79) | 98.73 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 5 (n= 80, 83) | 97.59 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 6A (n=78, 74) | 100.00 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose | 7F (n= 81, 82) | 100.00 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-5.59, 5.89]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-6.81, 7.37]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-10.87, 7.44]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-5.94, 5.94]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-8.66, 4.25]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-17.93, 3.56]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-6.74, 7.04]
Comparison: Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-16.37, 2.75]
Comparison: Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-3.37, 6.85]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-8.36, 5.14]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-4.73, 5.04]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-4.48, 4.55]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-4.48, 4.55]
Secondary
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Time frame: 1 Year After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 9V (n= 61, 63) | 62.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 1 (n= 76, 74) | 10.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 18C (n= 62, 60) | 38.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 3 (n=76, 70) | 47.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 6B (n= 65, 59) | 41.5 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 5 (n= 72, 70) | 20.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 19F (n= 67, 57) | 17.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 6A (n=70, 70) | 62.9 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 14 (n= 59, 54) | 86.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 7F (n= 71, 71) | 93.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 23F (n= 67, 62) | 49.3 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 19A (n= 74, 73) | 54.1 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 4 (n= 66, 59) | 34.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 19A (n= 74, 73) | 72.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 4 (n= 66, 59) | 42.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 6B (n= 65, 59) | 47.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 9V (n= 61, 63) | 73.0 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 14 (n= 59, 54) | 90.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 18C (n= 62, 60) | 61.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 19F (n= 67, 57) | 29.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 23F (n= 67, 62) | 77.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 1 (n= 76, 74) | 10.8 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 3 (n=76, 70) | 48.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 5 (n= 72, 70) | 31.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 6A (n=70, 70) | 81.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose | 7F (n= 71, 71) | 90.1 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-24.5, 9.9]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-23.6, 11.8]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-27.6, 6]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-17, 8.4]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-40, -4.9]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-27.4, 3.4]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-43.9, -11]
Comparison: Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-10.9, 10.3]
Comparison: Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-17.5, 15.1]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-25.3, 4.5]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-33.3, -3]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-7.1, 13.1]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-33.7, -2.8]
Secondary
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Time frame: 2 Years After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 9V (n= 50, 55) | 60.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 1 (n= 70, 68) | 8.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 18C (n= 56, 56) | 21.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 3 (n=69, 66) | 46.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 6B (n= 56, 48) | 35.7 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 5 (n= 68, 69) | 7.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 19F (n= 60, 58) | 25.0 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 6A (n=68, 62) | 44.1 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 14 (n= 49, 45) | 81.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 7F (n= 64, 65) | 68.8 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 23F (n= 58, 59) | 53.4 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 19A (n= 68, 67) | 45.6 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 4 (n= 46, 54) | 21.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 19A (n= 68, 67) | 67.2 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 4 (n= 46, 54) | 29.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 6B (n= 56, 48) | 35.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 9V (n= 50, 55) | 52.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 14 (n= 49, 45) | 84.4 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 18C (n= 56, 56) | 39.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 19F (n= 60, 58) | 29.3 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 23F (n= 58, 59) | 74.6 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 1 (n= 70, 68) | 2.9 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 3 (n=69, 66) | 51.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 5 (n= 68, 69) | 21.7 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 6A (n=68, 62) | 64.5 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose | 7F (n= 64, 65) | 80.0 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-25.2, 9.9]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-18.5, 19]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-12, 26.2]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-19.1, 13.3]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-34.6, -0.3]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-20.6, 12.1]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-37.8, -3.2]
Comparison: Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-2.7, 15.2]
Comparison: Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-22, 12]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-26.7, -2.4]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-36.8, -3]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-26.4, 4.1]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-37.7, -4.6]
Secondary
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
Percentage of participants achieving OPA titer \>=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Time frame: Before Toddler Dose (pre-vaccination)
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 9V (n=52, 63) | 19.23 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 1 (n=76, 80) | 11.84 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 18C (n=54, 58) | 44.44 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 3 (n=73, 77) | 32.88 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 6B (n=59, 62) | 22.03 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 5 (n=74, 79) | 8.11 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 19F (n=57, 60) | 8.77 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 6A (n=69, 76) | 52.17 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 14 (n=60, 55) | 86.67 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 7F (n=75, 79) | 78.67 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 23F (n=59, 62) | 23.73 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 19A (n=77, 79) | 25.97 percentage of participants |
| 13vPnC Group 1 (Preterm Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 4 (n=56, 59) | 21.43 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 19A (n=77, 79) | 29.11 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 4 (n=56, 59) | 30.51 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 6B (n=59, 62) | 27.42 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 9V (n=52, 63) | 12.70 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 14 (n=60, 55) | 94.55 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 18C (n=54, 58) | 55.17 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 19F (n=57, 60) | 1.67 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 23F (n=59, 62) | 37.10 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 1 (n=76, 80) | 3.75 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 3 (n=73, 77) | 40.26 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 5 (n=74, 79) | 7.59 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 6A (n=69, 76) | 72.37 percentage of participants |
| 13vPnC Group 2 (Term Infant) | Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose | 7F (n=75, 79) | 73.42 percentage of participants |
Comparison: Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-25.11, 7.49]
Comparison: Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-21.03, 10.4]
Comparison: Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-7.16, 21.16]
Comparison: Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-20.28, 3.35]
Comparison: Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-29.01, 8.11]
Comparison: Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-1.52, 17.65]
Comparison: Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-29.57, 3.31]
Comparison: Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-0.52, 17.81]
Comparison: Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-22.86, 8.29]
Comparison: Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-8.82, 10.08]
Comparison: Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-35.45, -3.95]
Comparison: Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-8.5, 19.06]
Comparison: Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.95% CI: [-17.51, 11.13]
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: 1 Month After Infant Series
Population: Evaluable Infant Immunogenicity Population. Here n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 6A (n=88, 88) | 1566 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 4 (n=58, 62) | 1231 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 6B (n=51, 61) | 835 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 9V (n=54, 60) | 151 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 14 (n=55, 66) | 1298 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 18C (n=56, 63) | 2931 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 19F (n= 55, 58) | 417 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 23F (n=55, 60) | 733 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 1 (n=88, 87) | 10 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 3 (n=83, 86) | 61 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 5 (n=83, 85) | 37 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 7F (n=93, 86) | 1605 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 19A (n=92, 86) | 283 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 5 (n=83, 85) | 64 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 23F (n=55, 60) | 582 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 4 (n=58, 62) | 923 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 6A (n=88, 88) | 1287 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 6B (n=51, 61) | 732 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 1 (n=88, 87) | 13 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 9V (n=54, 60) | 211 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 19A (n=92, 86) | 244 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 14 (n=55, 66) | 1033 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 3 (n=83, 86) | 57 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 18C (n=56, 63) | 2057 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 7F (n=93, 86) | 1539 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series | 19F (n= 55, 58) | 335 titer |
Comparison: Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.99, 1.81]
Comparison: Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.59, 2.2]
Comparison: Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.26, 1.93]
Comparison: Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.8, 1.98]
Comparison: Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [1.01, 2]
Comparison: Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.82, 1.89]
Comparison: Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.8, 1.99]
Comparison: Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.56, 1.15]
Comparison: Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.83, 1.41]
Comparison: Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.36, 0.94]
Comparison: Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.88, 1.68]
Comparison: Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.78, 1.39]
Comparison: Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.89, 1.51]
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: 1 Month After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 9V (n=60, 58) | 1871 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 1 (n=80, 83) | 59 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 18C (n= 62, 63) | 2464 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 3 (n=78, 79) | 114 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 6B (n= 64, 61) | 1229 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 5 (n=80, 83) | 166 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 19F (n= 61, 62) | 376 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 6A (n=78, 74) | 1978 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 14 (n= 62, 62) | 1294 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 7F (n=81, 82) | 2915 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 23F (n=65, 63) | 1048 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 19A (n=81, 82) | 558 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 4 (n= 67, 61) | 1154 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 19A (n=81, 82) | 825 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 4 (n= 67, 61) | 1757 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 6B (n= 64, 61) | 1406 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 9V (n=60, 58) | 2542 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 14 (n= 62, 62) | 1651 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 18C (n= 62, 63) | 4510 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 19F (n= 61, 62) | 640 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 23F (n=65, 63) | 1657 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 1 (n=80, 83) | 107 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 3 (n=78, 79) | 121 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 5 (n=80, 83) | 260 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 6A (n=78, 74) | 3154 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose | 7F (n=81, 82) | 3154 titer |
Comparison: Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.45, 0.97]
Comparison: Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.54, 1.4]
Comparison: Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.41, 1.31]
Comparison: Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.54, 1.14]
Comparison: Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.34, 0.87]
Comparison: Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.31, 1.1]
Comparison: Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.4, 1.01]
Comparison: Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.38, 0.81]
Comparison: Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.76, 1.17]
Comparison: Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.45, 0.91]
Comparison: Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.47, 0.85]
Comparison: Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.74, 1.15]
Comparison: Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.52, 0.88]
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: 1 Year After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 9V (n=61, 63) | 141 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 1 (n=76, 74) | 5 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 18C (n= 62, 60) | 33 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 3 (n=76, 70) | 11 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 6B (n= 65, 59) | 38 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 5 (n=72, 70) | 8 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 19F (n= 67, 57) | 11 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 6A (n=70, 70) | 98 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 14 (n= 59, 54) | 276 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 7F (n=71, 71) | 599 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 23F (n=67, 62) | 45 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 19A (n=74, 73) | 28 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 4 (n= 66, 59) | 24 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 19A (n=74, 73) | 54 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 4 (n= 66, 59) | 29 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 6B (n= 65, 59) | 36 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 9V (n=61, 63) | 244 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 14 (n= 59, 54) | 372 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 18C (n= 62, 60) | 121 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 19F (n= 67, 57) | 18 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 23F (n=67, 62) | 168 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 1 (n=76, 74) | 5 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 3 (n=76, 70) | 13 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 5 (n=72, 70) | 10 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 6A (n=70, 70) | 255 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose | 7F (n=71, 71) | 533 titer |
Comparison: Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.35, 2.05]
Comparison: Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.41, 2.63]
Comparison: Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.22, 1.53]
Comparison: Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.38, 1.44]
Comparison: Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.1, 0.76]
Comparison: Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.25, 1.3]
Comparison: Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.11, 0.65]
Comparison: Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.81, 1.32]
Comparison: Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.56, 1.37]
Comparison: Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.51, 1.23]
Comparison: Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.17, 0.86]
Comparison: Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.64, 1.97]
Comparison: Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.27, 0.97]
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: 2 Years After Toddler Dose
Population: Evaluable Toddler Immunogenicity Population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 9V (n=50, 55) | 132 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 1 (n=70, 68) | 5 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 18C (n= 56, 56) | 14 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 3 (n=69, 66) | 11 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 6B (n= 56, 48) | 29 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 5 (n=68, 69) | 5 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 19F (n= 60, 58) | 13 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 6A (n=68, 62) | 42 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 14 (n= 49, 45) | 262 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 7F (n=64, 65) | 170 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 23F (n=58, 59) | 60 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 19A (n=68, 67) | 22 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 4 (n= 46, 54) | 15 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 19A (n=68, 67) | 50 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 4 (n= 46, 54) | 17 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 6B (n= 56, 48) | 27 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 9V (n=50, 55) | 75 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 14 (n= 49, 45) | 296 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 18C (n= 56, 56) | 29 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 19F (n= 60, 58) | 20 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 23F (n=58, 59) | 135 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 1 (n=70, 68) | 4 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 3 (n=69, 66) | 16 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 5 (n=68, 69) | 7 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 6A (n=68, 62) | 102 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose | 7F (n=64, 65) | 269 titer |
Comparison: Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.33, 2.37]
Comparison: Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.37, 3.07]
Comparison: Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.57, 5.36]
Comparison: Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.38, 2.07]
Comparison: Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.18, 1.21]
Comparison: Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.27, 1.53]
Comparison: Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.17, 1.15]
Comparison: Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.96, 1.31]
Comparison: Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.41, 1.14]
Comparison: Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.49, 0.92]
Comparison: Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.16, 1.03]
Comparison: Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.27, 1.48]
Comparison: Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.22, 0.91]
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: Before the toddler dose (pre-vaccination)
Population: Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 9V (n=52, 63) | 11 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 1 (n=76, 80) | 6 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 18C (n= 54, 58) | 32 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 3 (n=73, 77) | 8 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 6B (n= 59, 62) | 12 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 5 (n=74, 79) | 5 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 19F (n= 57, 60) | 6 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 6A (n=69, 76) | 45 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 14 (n= 60, 55) | 242 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 7F (n=75, 79) | 228 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 23F (n=59, 62) | 11 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 19A (n=77, 79) | 9 titer |
| 13vPnC Group 1 (Preterm Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 4 (n= 56, 59) | 10 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 19A (n=77, 79) | 10 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 4 (n= 56, 59) | 13 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 6B (n= 59, 62) | 15 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 9V (n=52, 63) | 7 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 14 (n= 60, 55) | 389 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 18C (n= 54, 58) | 51 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 19F (n= 57, 60) | 4 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 23F (n=59, 62) | 16 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 1 (n=76, 80) | 4 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 3 (n=73, 77) | 8 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 5 (n=74, 79) | 5 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 6A (n=69, 76) | 91 titer |
| 13vPnC Group 2 (Term Infant) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose | 7F (n=75, 79) | 188 titer |
Comparison: Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.37, 1.44]
Comparison: Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.37, 1.71]
Comparison: Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.76, 3.12]
Comparison: Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.33, 1.17]
Comparison: Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.24, 1.55]
Comparison: Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.97, 1.77]
Comparison: Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.35, 1.46]
Comparison: Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [1, 1.6]
Comparison: Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.68, 1.33]
Comparison: Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.82, 1.31]
Comparison: Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.24, 1.04]
Comparison: Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.58, 2.53]
Comparison: Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the 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.95% CI: [0.52, 1.37]