Study Evaluating a 13-valent Pneumococcal Conjugate Vacci... | NCT01193335 | Trialant
NCT01193335
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 11, 2017Actual
Enrollment
200Actual
Phase
Phase 4
Conditions
13-valent Pneumococcal Vaccine
Premature Birth
Immunization
Safety
Interventions
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Countries
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT01193335
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1851037
Secondary IDs
ID
Type
Description
Link
6096A1-4001
Other Identifier
Alias Study Number
2009-017332-41
EudraCT Number
Brief Title
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Official Title
A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Sep 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2010
Primary Completion Date
Jan 2014Actual
Completion Date
Jan 2014Actual
First Submitted Date
Aug 31, 2010
First Submission Date that Met QC Criteria
Aug 31, 2010
First Posted Date
Sep 1, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 21, 2015
Results First Submitted that Met QC Criteria
Jan 21, 2015
Results First Posted Date
Feb 4, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 5, 2017
Last Update Posted Date
May 11, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Group 1: Preterm infants
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
1 month after the infant series
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.
1 month after the infant series
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.
Within 7 days after Dose 1 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
42 Days
Maximum Age
98 Days
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
NZOZ "HIPOKRATES-II" Sp. z o.o.
Krakow
31-223
Poland
Hanna Czajka Indywidualna Praktyka Specjalistyczna Lekarska
Martinon-Torres F, Wysocki J, Center KJ, Czajka H, Majda-Stanislawska E, Omenaca F, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Blazquez-Gamero D, Moreno-Galarraga L, Giardina PC, Sun G, Gruber WC, Scott DA, Gurtman A. Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants. Pediatr Infect Dis J. 2017 Mar;36(3):326-332. doi: 10.1097/INF.0000000000001428.
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).
Periods
Title
Milestones
Reasons Not Completed
Infant Series
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
13-valent pneumococcal conjugate vaccine
Biological
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Group 2: Term infants
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.
Within 7 days after Dose 2 of the infant series
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.
Within 7 days after Dose 3 of the infant series
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.
Within 7 days after the toddler dose
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.
Within 7 days after Dose 1 of the infant series
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.
Within 7 days after Dose 2 of the infant series
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.
Within 7 days after Dose 3 of the infant series
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.
Within 7 days after the toddler dose
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.
Dose 1 up to 1 month after Dose 3 (infant series)
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.
1 Month after Dose 3 of the infant series up to toddler dose
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.
Toddler dose up to 1 Month after toddler dose
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.
1 month after toddler dose up to 1-year follow-up
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.
1-year follow-up after toddler dose to 2-year follow-up after toddler dose
Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
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.
1 Month After Infant Series
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.
1 month after the toddler dose
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.
1 month after the toddler dose
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.
Before Toddler Dose (pre-vaccination)
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.
1 Month After Toddler Dose
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.
1 Year After Toddler Dose
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.
2 Years After Toddler Dose
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.
1 Month After Infant Series
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.
Before Toddler Dose (pre-vaccination)
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.
1 Month After Toddler Dose
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.
1 Year After Toddler Dose
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.
2 Years After Toddler Dose
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).
1 Month After Infant Series
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).
Before the toddler dose (pre-vaccination)
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).
1 Month After Toddler Dose
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).
1 Year After Toddler Dose
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).
2 Years After Toddler Dose
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.
1 Month After Infant Series
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.
Before Toddler Dose (pre-vaccination)
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.
1 Month After Toddler Dose
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.
1 Year After Toddler Dose
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.
2 Years After Toddler Dose
Krakow
31-302
Poland
SP ZOZ Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego w Lodzi
Lodz
91-347
Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem
Poznan
61-825
Poland
Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
Trzebnica
55-100
Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw
50-345
Poland
Hospital Universitario de Santiago de Compostela
Santiago de Compostela
A Coruña
15706
Spain
Complejo Hospitalario DE Torrecardenas
AlmerÃa
Almeria
04009
Spain
Complexo Hospitalario Xeral Cies
Vigo
Pontevedra
36204
Spain
Hospital 12 de Octubre
Madrid
28041
Spain
Hospital Universitario de La Paz
Madrid
28046
Spain
Complejo Hospitalario de Navarra
Pamplona
31008
Spain
Derived
Martinon-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omenaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941. Epub 2015 Mar 16.
FG001
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).
FG000100 subjects
FG001100 subjects
COMPLETED
FG000100 subjects
FG001100 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000100 subjects
FG001100 subjects
COMPLETED
FG00099 subjects
FG00197 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0012 subjects
No Longer Met Eligibility Criteria
FG0000 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG00099 subjects
FG00197 subjects
COMPLETED
FG00099 subjects
FG00197 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
1-Year Follow-up
Type
Comment
Milestone Data
STARTED
FG00099 subjects
FG00197 subjects
COMPLETED
FG00088 subjects
FG00188 subjects
NOT COMPLETED
FG00011 subjects
FG0019 subjects
Type
Comment
Reasons
No Longer Willing to Participate
FG0007 subjects
FG0019 subjects
Lost to Follow-up
FG0004 subjects
FG001
2-Year Follow-up
Type
Comment
Milestone Data
STARTED
FG00088 subjects
FG00188 subjects
COMPLETED
FG00081 subjects
FG00180 subjects
NOT COMPLETED
FG0007 subjects
FG0018 subjects
Type
Comment
Reasons
No Longer Willing to Participate
FG0005 subjects
FG0016 subjects
No Longer Met Eligibility Criteria
FG0002 subjects
FG001
Safety Analysis set included all participants who received at least 1 dose of 13vPnC.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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).
BG001
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).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000100
BG001100
BG002200
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0001.8± 0.6
BG0011.5± 0.5
BG0021.7± 0.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00048
BG00155
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series
ID
Title
Description
OG000
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).
OG001
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).
Units
Counts
Participants
OG00099
OG00198
Title
Denominators
Categories
4 (n=99, 97)
Title
Measurements
OG00096.97(91.40 to 99.37)
OG00198.97(94.39 to 99.97)
6B (n=99, 97)
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent difference
-2.00
2-Sided
95
-7.65
2.88
Superiority or Other
OG000
OG001
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.
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.
Evaluable infant immunogenicity population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the infant series
ID
Title
Description
OG000
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).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Number
percentage of participants
Within 7 days after Dose 1 of the infant series
ID
Title
Description
OG000
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).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Number
percentage of participants
Within 7 days after Dose 2 of the infant series
ID
Title
Description
OG000
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).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Number
percentage of participants
Within 7 days after Dose 3 of the infant series
ID
Title
Description
OG000
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).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Number
percentage of participants
Within 7 days after the toddler dose
ID
Title
Description
OG000
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).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Number
percentage of participants
Within 7 days after Dose 1 of the infant series
ID
Title
Description
OG000
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).
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.
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.
Posted
Number
percentage of participants
Within 7 days after Dose 2 of the infant series
ID
Title
Description
OG000
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).
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.
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.
Posted
Number
percentage of participants
Within 7 days after Dose 3 of the infant series
ID
Title
Description
OG000
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).
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.
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.
Posted
Number
percentage of participants
Within 7 days after the toddler dose
ID
Title
Description
OG000
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).
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.
Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.
Posted
Number
percentage of participants
Dose 1 up to 1 month after Dose 3 (infant series)
ID
Title
Description
OG000
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).
OG001
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).
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.
Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.
Posted
Number
percentage of participants
1 Month after Dose 3 of the infant series up to toddler dose
ID
Title
Description
OG000
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).
OG001
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).
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.
Safety population for toddler dose included all participants who received 13vPnC toddler dose.
Posted
Number
percentage of participants
Toddler dose up to 1 Month after toddler dose
ID
Title
Description
OG000
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).
OG001
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).
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.
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.
Posted
Number
percentage of participants
1 month after toddler dose up to 1-year follow-up
ID
Title
Description
OG000
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).
OG001
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).
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.
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.
Posted
Number
percentage of participants
1-year follow-up after toddler dose to 2-year follow-up after toddler dose
ID
Title
Description
OG000
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).
OG001
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).
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.
Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 Month After Infant Series
ID
Title
Description
OG000
13vPnC Group 1A
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC Group 1B
Preterm infant participants with GA >=29 weeks and <32 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).
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
13vPnC Group 2 (Term Infant)
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.
Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC (Group 1A)
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC (Group 1B)
Preterm infant participants with GA >=29 weeks and <32 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).
OG002
13vPnC (Group 1C)
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.
Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
Before Toddler Dose (pre-vaccination)
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
Evaluable Toddler Immunogenicity Population.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 Month After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 Year After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
13vPnC Group 2 (Term Infant)
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.
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.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
2 Years After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
13vPnC Group 2 (Term Infant)
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.
Evaluable Infant Immunogenicity Population.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 Month After Infant Series
ID
Title
Description
OG000
13vPnC (Group 1A)
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC (Group 1B)
Preterm infant participants with GA >=29 weeks and <32 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).
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.
Evaluable Toddler Immunogenicity Population.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
Before Toddler Dose (pre-vaccination)
ID
Title
Description
OG000
13vPnC (Group 1A)
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC (Group 1B)
Preterm infant participants with GA >=29 weeks and <32 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).
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.
Evaluable Toddler Immunogenicity Population.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 Month After Toddler Dose
ID
Title
Description
OG000
13vPnC (Group 1A)
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC (Group 1B)
Preterm infant participants with GA >=29 weeks and <32 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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 Year After Toddler Dose
ID
Title
Description
OG000
13vPnC (Group 1A)
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC (Group 1B)
Preterm infant participants with GA >=29 weeks and <32 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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
2 Years After Toddler Dose
ID
Title
Description
OG000
13vPnC (Group 1A)
Preterm infant participants with GA >=32 weeks and <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).
OG001
13vPnC (Group 1B)
Preterm infant participants with GA >=29 weeks and <32 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).
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).
Evaluable Infant Immunogenicity Population. Here n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Posted
Geometric Mean
95% Confidence Interval
titer
1 Month After Infant Series
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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).
Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Posted
Geometric Mean
95% Confidence Interval
titer
Before the toddler dose (pre-vaccination)
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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).
Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Posted
Geometric Mean
95% Confidence Interval
titer
1 Month After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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).
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.
Posted
Geometric Mean
95% Confidence Interval
titer
1 Year After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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).
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.
Posted
Geometric Mean
95% Confidence Interval
titer
2 Years After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
Evaluable Infant Immunogenicity Population. Here 'n' signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.
Posted
Number
95% Confidence Interval
percentage of participants
1 Month After Infant Series
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.
Posted
Number
95% Confidence Interval
percentage of participants
Before Toddler Dose (pre-vaccination)
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 Month After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 Year After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
2 Years After Toddler Dose
ID
Title
Description
OG000
13vPnC Group 1 (Preterm Infant)
Preterm 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). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
OG001
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).
Time Frame
AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
Description
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
13vPnC Group 1 (Preterm Infant) - Infant Series
Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
14
100
98
100
EG001
13vPnC Group 2 (Term Infant) - Infant Series
Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
5
100
99
100
EG002
13vPnC Group 1 (Preterm Infant) - After Infant Series
Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
8
100
13
100
EG003
13vPnC Group 2 (Term Infant) - After Infant Series
Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
9
100
11
100
EG004
13vPnC Group 1 (Preterm Infant) - Toddler Dose
Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
2
99
93
99
EG005
13vPnC Group 2 (Term Infant) - Toddler Dose
Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
1
97
92
97
EG006
13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up
Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
13
99
2
99
EG007
13vPnC Group 2 (Term Infant) - 1 Year Follow-up
Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
8
97
0
97
EG008
13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up
Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
6
88
1
88
EG009
13vPnC Group 2 (Term Infant) - 2 Year Follow-up
Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
8
88
1
88
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG0030 affected100 at risk
EG0040 affected99 at risk
EG0050 affected97 at risk
EG0060 affected99 at risk
EG0070 affected97 at risk
EG0080 affected88 at risk
EG0090 affected88 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Inguinal hernia, obstructive
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0021 affected100 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Adenoviral upper respiratory infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected100 at risk
EG0012 affected100 at risk
EG0021 affected100 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0022 affected100 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0011 affected100 at risk
EG0023 affected100 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0021 affected100 at risk
EG003
Human herpesvirus 6 infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Viral rash
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Encephalitis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Ovarian cyst torsion
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Hip dysplasia
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Cerebral palsy
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Autism spectrum disorder
Psychiatric disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Arthritis reactive
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0021 affected100 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
CSF shunt operation
Surgical and medical procedures
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG0030 affected100 at risk
EG0040 affected99 at risk
EG0050 affected97 at risk
EG0060 affected99 at risk
EG0070 affected97 at risk
EG0080 affected88 at risk
EG0090 affected88 at risk
Craniotabes
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Eye discharge
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0013 affected100 at risk
EG0021 affected100 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected100 at risk
EG0011 affected100 at risk
EG0021 affected100 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Irritability
General disorders
MedDRA
Non-systematic Assessment
EG0005 affected100 at risk
EG0013 affected100 at risk
EG0020 affected100 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0014 affected100 at risk
EG0021 affected100 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Food allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0012 affected100 at risk
EG0020 affected100 at risk
EG003
Milk allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected100 at risk
EG0016 affected100 at risk
EG0020 affected100 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0016 affected100 at risk
EG0021 affected100 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0012 affected100 at risk
EG0020 affected100 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0006 affected100 at risk
EG0015 affected100 at risk
EG0020 affected100 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0021 affected100 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected100 at risk
EG0021 affected100 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0008 affected100 at risk
EG0019 affected100 at risk
EG0024 affected100 at risk
EG003
Respiratory tract infection bacterial
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected100 at risk
EG0014 affected100 at risk
EG0022 affected100 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0008 affected100 at risk
EG00110 affected100 at risk
EG0021 affected100 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected100 at risk
EG0021 affected100 at risk
EG003
Viral infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Viral rash
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0021 affected100 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0003 affected100 at risk
EG0012 affected100 at risk
EG0020 affected100 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0003 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Subdural hygroma
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Allergic respiratory disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0012 affected100 at risk
EG0020 affected100 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected100 at risk
EG0020 affected100 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Beckwith-Wiedemann syndrome
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0021 affected100 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Herpangina
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Developmental delay
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected100 at risk
EG0020 affected100 at risk
EG003
Tenderness- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00046 affected94 at risk
EG00137 affected88 at risk
EG0020 affected0 at risk
EG003
Tenderness- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00041 affected85 at risk
EG00134 affected88 at risk
EG0020 affected0 at risk
EG003
Tenderness- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG00032 affected82 at risk
EG00124 affected84 at risk
EG0020 affected0 at risk
EG003
Tenderness- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00043 affected93 at risk
EG00128 affected88 at risk
EG0020 affected0 at risk
EG003
Tenderness- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00037 affected85 at risk
EG00126 affected84 at risk
EG0020 affected0 at risk
EG003
Tenderness- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG00029 affected81 at risk
EG00122 affected84 at risk
EG0020 affected0 at risk
EG003
Tenderness- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00016 affected90 at risk
EG00114 affected85 at risk
EG0020 affected0 at risk
EG003
Tenderness- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00011 affected77 at risk
EG00113 affected83 at risk
EG0020 affected0 at risk
EG003
Tenderness- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG0007 affected75 at risk
EG0014 affected78 at risk
EG0020 affected0 at risk
EG003
Tenderness- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0000 affected86 at risk
EG0010 affected85 at risk
EG0020 affected0 at risk
EG003
Tenderness- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG0000 affected73 at risk
EG0011 affected77 at risk
EG0020 affected0 at risk
EG003
Tenderness- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG0000 affected73 at risk
EG0010 affected77 at risk
EG0020 affected0 at risk
EG003
Swelling- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00037 affected94 at risk
EG00126 affected89 at risk
EG0020 affected0 at risk
EG003
Swelling- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00030 affected84 at risk
EG00135 affected82 at risk
EG0020 affected0 at risk
EG003
Swelling- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG00025 affected83 at risk
EG00135 affected85 at risk
EG0020 affected0 at risk
EG003
Swelling- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00034 affected91 at risk
EG00125 affected89 at risk
EG0020 affected0 at risk
EG003
Swelling- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00028 affected83 at risk
EG00135 affected82 at risk
EG0020 affected0 at risk
EG003
Swelling- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG00022 affected82 at risk
EG00135 affected85 at risk
EG0020 affected0 at risk
EG003
Swelling- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0008 affected91 at risk
EG0017 affected85 at risk
EG0020 affected0 at risk
EG003
Swelling- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG0006 affected75 at risk
EG0012 affected76 at risk
EG0020 affected0 at risk
EG003
Swelling- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG0004 affected75 at risk
EG0014 affected79 at risk
EG0020 affected0 at risk
EG003
Swelling- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0000 affected86 at risk
EG0010 affected85 at risk
EG0020 affected0 at risk
EG003
Swelling- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG0000 affected73 at risk
EG0010 affected76 at risk
EG0020 affected0 at risk
EG003
Swelling- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG0000 affected73 at risk
EG0010 affected77 at risk
EG0020 affected0 at risk
EG003
Redness- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00031 affected92 at risk
EG00126 affected87 at risk
EG0020 affected0 at risk
EG003
Redness- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00023 affected82 at risk
EG00133 affected82 at risk
EG0020 affected0 at risk
EG003
Redness- Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG00027 affected82 at risk
EG00140 affected87 at risk
EG0020 affected0 at risk
EG003
Redness- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00029 affected90 at risk
EG00125 affected87 at risk
EG0020 affected0 at risk
EG003
Redness- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG00023 affected82 at risk
EG00131 affected82 at risk
EG0020 affected0 at risk
EG003
Redness- Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG00027 affected82 at risk
EG00140 affected87 at risk
EG0020 affected0 at risk
EG003
Redness- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0003 affected88 at risk
EG0014 affected85 at risk
EG0020 affected0 at risk
EG003
Redness- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG0002 affected73 at risk
EG0012 affected76 at risk
EG0020 affected0 at risk
EG003
Redness- Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG0001 affected74 at risk
EG0013 affected79 at risk
EG0020 affected0 at risk
EG003
Redness- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0000 affected86 at risk
EG0010 affected85 at risk
EG0020 affected0 at risk
EG003
Redness- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 2 Infant Series
EG0000 affected73 at risk
EG0010 affected76 at risk
EG0020 affected0 at risk
EG003
Redness- Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Dose 3 Infant Series
EG0000 affected73 at risk
EG0010 affected77 at risk
EG0020 affected0 at risk
EG003
Fever >=38 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00010 affected86 at risk
EG00112 affected88 at risk
EG0020 affected0 at risk
EG003
Fever >=38 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00022 affected79 at risk
EG00125 affected79 at risk
EG0020 affected0 at risk
EG003
Fever >=38 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00022 affected79 at risk
EG00125 affected81 at risk
EG0020 affected0 at risk
EG003
Fever >=38 degrees C, =<39 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0009 affected86 at risk
EG00112 affected88 at risk
EG0020 affected0 at risk
EG003
Fever >=38 degrees C, =<39 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00022 affected79 at risk
EG00124 affected79 at risk
EG0020 affected0 at risk
EG003
Fever >=38 degrees C, =<39 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00021 affected78 at risk
EG00125 affected81 at risk
EG0020 affected0 at risk
EG003
Fever >=39 degrees C, =<40 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0001 affected86 at risk
EG0010 affected85 at risk
EG0020 affected0 at risk
EG003
Fever >=39 degrees C, =<40 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG0000 affected73 at risk
EG0011 affected76 at risk
EG0020 affected0 at risk
EG003
Fever >=39 degrees C, =<40 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG0001 affected75 at risk
EG0012 affected78 at risk
EG0020 affected0 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0000 affected86 at risk
EG0010 affected85 at risk
EG0020 affected0 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG0000 affected73 at risk
EG0010 affected76 at risk
EG0020 affected0 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG0000 affected74 at risk
EG0010 affected77 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Any
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00056 affected92 at risk
EG00137 affected89 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Any
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00055 affected89 at risk
EG00139 affected84 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Any
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00040 affected82 at risk
EG00140 affected84 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00050 affected91 at risk
EG00131 affected88 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00049 affected88 at risk
EG00135 affected84 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00030 affected82 at risk
EG00139 affected84 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00018 affected88 at risk
EG00115 affected87 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00020 affected79 at risk
EG00115 affected78 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00013 affected74 at risk
EG00113 affected79 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0001 affected86 at risk
EG0010 affected85 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG0001 affected73 at risk
EG0010 affected76 at risk
EG0020 affected0 at risk
EG003
Decreased Appetite- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG0001 affected74 at risk
EG0011 affected77 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Any
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00065 affected96 at risk
EG00166 affected95 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Any
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00063 affected85 at risk
EG00157 affected89 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Any
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00046 affected88 at risk
EG00151 affected88 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00058 affected96 at risk
EG00157 affected93 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00058 affected83 at risk
EG00152 affected88 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00043 affected88 at risk
EG00145 affected87 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00026 affected87 at risk
EG00127 affected88 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00027 affected78 at risk
EG00123 affected78 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00013 affected77 at risk
EG00116 affected80 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0002 affected86 at risk
EG0012 affected85 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG0002 affected73 at risk
EG0011 affected76 at risk
EG0020 affected0 at risk
EG003
Increased Sleep- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG0001 affected73 at risk
EG0011 affected77 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Any
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00080 affected95 at risk
EG00180 affected97 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Any
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00085 affected95 at risk
EG00174 affected95 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Any
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00073 affected92 at risk
EG00177 affected95 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00072 affected93 at risk
EG00166 affected95 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00073 affected90 at risk
EG00166 affected92 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Mild
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00065 affected90 at risk
EG00168 affected91 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep-Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00040 affected92 at risk
EG00143 affected91 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep-Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00055 affected85 at risk
EG00138 affected86 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep-Moderate
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00027 affected80 at risk
EG00131 affected87 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG0007 affected86 at risk
EG0015 affected85 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00013 affected74 at risk
EG0012 affected76 at risk
EG0020 affected0 at risk
EG003
Irritability or Decreased Sleep- Severe
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG0005 affected74 at risk
EG0015 affected78 at risk
EG0020 affected0 at risk
EG003
Use of Antipyretic Medication
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series and Toddler Dose
EG00022 affected90 at risk
EG00122 affected90 at risk
EG0020 affected0 at risk
EG003
Use of Antipyretic Medication
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00041 affected84 at risk
EG00138 affected83 at risk
EG0020 affected0 at risk
EG003
Use of Antipyretic Medication
General disorders
Systemic Events
Systematic Assessment
Dose 3 Infant Series
EG00034 affected84 at risk
EG00131 affected81 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D047928
Premature Birth
Ancestor Terms
ID
Term
D007752
Obstetric Labor, Premature
D007744
Obstetric Labor Complications
D011248
Pregnancy Complications
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
0 subjects
2 subjects
103
Male
BG00052
BG00145
BG00297
72.73
(62.85 to 81.20)
OG00187.63(79.39 to 93.44)
9V (n=99, 97)
Title
Measurements
OG00096.97(91.40 to 99.37)
OG00196.91(91.23 to 99.36)
14 (n=99, 97)
Title
Measurements
OG000100.00(96.34 to 100.00)
OG00197.94(92.75 to 99.75)
18C (n=99, 97)
Title
Measurements
OG00096.97(91.40 to 99.37)
OG00194.85(88.38 to 98.31)
19F (n=99, 97)
Title
Measurements
OG00098.99(94.50 to 99.97)
OG00198.97(94.39 to 99.97)
23F (n=99, 97 )
Title
Measurements
OG00085.86(77.41 to 92.05)
OG00192.78(85.70 to 97.05)
1 (n=99, 97)
Title
Measurements
OG00093.94(87.27 to 97.74)
OG00195.88(89.78 to 98.87)
3 (n=99, 97)
Title
Measurements
OG00085.86(77.41 to 92.05)
OG00190.72(83.12 to 95.67)
5 (n=99, 97)
Title
Measurements
OG00071.72(61.78 to 80.31)
OG00190.72(83.12 to 95.67)
6A (n=98, 97)
Title
Measurements
OG00082.65(73.69 to 89.56)
OG00194.85(88.38 to 98.31)
7F (n=99, 97)
Title
Measurements
OG00098.99(94.50 to 99.97)
OG00198.97(94.39 to 99.97)
19A (n=99, 97)
Title
Measurements
OG00098.99(94.50 to 99.97)
OG00198.97(94.39 to 99.97)
Percent difference
-14.90
2-Sided
95
-26.40
-3.21
Superiority or Other
OG000
OG001
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.
Percent difference
0.06
2-Sided
95
-5.84
6.05
Superiority or Other
OG000
OG001
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.
Percent difference
2.06
2-Sided
95
-1.71
7.25
Superiority or Other
OG000
OG001
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.
Percent difference
2.12
2-Sided
95
-4.09
8.89
Superiority or Other
OG000
OG001
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.
Percent difference
0.02
2-Sided
95
-4.54
4.68
Superiority or Other
OG000
OG001
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.
Percent difference
-6.92
2-Sided
95
-16.19
1.89
Superiority or Other
OG000
OG001
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.
Percent difference
-1.94
2-Sided
95
-9.07
4.86
Superiority or Other
OG000
OG001
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.
Percent difference
-4.86
2-Sided
95
-14.40
4.39
Superiority or Other
OG000
OG001
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.
Percent difference
-19.00
2-Sided
95
-30.10
-7.16
Superiority or Other
OG000
OG001
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.
Percent difference
-12.19
2-Sided
95
-21.66
-3.26
Superiority or Other
OG000
OG001
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.
Percent difference
0.02
2-Sided
95
-4.54
4.68
Superiority or Other
OG000
OG001
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.
Percent difference
0.02
2-Sided
95
-4.54
4.68
Superiority or Other
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).
Units
Counts
Participants
OG00099
OG00198
Title
Denominators
Categories
4 (n=99, 97)
Title
Measurements
OG0001.96(1.67 to 2.31)
OG0012.46(2.04 to 2.97)
6B (n=99, 97)
Title
Measurements
OG0000.73(0.55 to 0.97)
OG0011.30(1.00 to 1.67)
9V (n=99, 97)
Title
Measurements
OG0001.26(1.08 to 1.47)
OG0011.70(1.45 to 2.00)
14 (n=99, 97)
Title
Measurements
OG0007.48(6.23 to 8.99)
OG0016.08(4.82 to 7.67)
18C (n=99, 97)
Title
Measurements
OG0001.93(1.66 to 2.24)
OG0011.93(1.62 to 2.29)
19F (n=99, 97)
Title
Measurements
OG0002.21(1.89 to 2.58)
OG0013.05(2.62 to 3.55)
23F (n=99, 97)
Title
Measurements
OG0000.86(0.69 to 1.07)
OG0011.36(1.10 to 1.68)
1 (n=99, 97)
Title
Measurements
OG0001.26(1.06 to 1.48)
OG0011.79(1.50 to 2.13)
3 (n=99, 97)
Title
Measurements
OG0000.83(0.70 to 0.98)
OG0010.86(0.75 to 1.00)
5 (n=99, 97)
Title
Measurements
OG0000.56(0.44 to 0.70)
OG0011.03(0.87 to 1.22)
6A (n=98, 97)
Title
Measurements
OG0001.22(0.98 to 1.53)
OG0012.01(1.65 to 2.46)
7F (n=99, 97)
Title
Measurements
OG0002.14(1.81 to 2.53)
OG0013.02(2.63 to 3.48)
19A (n=99, 97)
Title
Measurements
OG0002.85(2.44 to 3.33)
OG0013.35(2.85 to 3.94)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMC ratio
0.80
2-Sided
95
0.62
1.02
Superiority or Other
OG000
OG001
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.
GMC ratio
0.56
2-Sided
95
0.38
0.82
Superiority or Other
OG000
OG001
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.
GMC ratio
0.74
2-Sided
95
0.59
0.93
Superiority or Other
OG000
OG001
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.
GMC ratio
1.23
2-Sided
95
0.92
1.65
Superiority or Other
OG000
OG001
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.
GMC ratio
1.00
2-Sided
95
0.80
1.25
Superiority or Other
OG000
OG001
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.
GMC ratio
0.72
2-Sided
95
0.58
0.90
Superiority or Other
OG000
OG001
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.
GMC ratio
0.64
2-Sided
95
0.47
0.86
Superiority or Other
OG000
OG001
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.
GMC ratio
0.70
2-Sided
95
0.55
0.89
Superiority or Other
OG000
OG001
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.
GMC ratio
0.96
2-Sided
95
0.77
1.19
Superiority or Other
OG000
OG001
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.
GMC ratio
0.54
2-Sided
95
0.40
0.72
Superiority or Other
OG000
OG001
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.
GMC ratio
0.61
2-Sided
95
0.45
0.82
Superiority or Other
OG000
OG001
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.
GMC ratio
0.71
2-Sided
95
0.57
0.88
Superiority or Other
OG000
OG001
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.
GMC ratio
0.85
2-Sided
95
0.68
1.07
Superiority or Other
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).
Units
Counts
Participants
OG00098
OG00192
Title
Denominators
Categories
Tenderness- Any (n=94, 88)
Title
Measurements
OG00048.9
OG00142.0
Tenderness- Mild (n=93, 88)
Title
Measurements
OG00046.2
OG00131.8
Tenderness- Moderate (n=90, 85)
Title
Measurements
OG00017.8
OG00116.5
Tenderness- Severe (n=86, 85)
Title
Measurements
OG0000.0
OG0010.0
Swelling- Any (n=94, 89)
Title
Measurements
OG00039.4
OG00129.2
Swelling- Mild (n=91, 89)
Title
Measurements
OG00037.4
OG00128.1
Swelling- Moderate (n=91, 85)
Title
Measurements
OG0008.8
OG0018.2
Swelling- Severe (n=86, 85)
Title
Measurements
OG0000.0
OG0010.0
Redness- Any (n=92, 87)
Title
Measurements
OG00033.7
OG00129.9
Redness- Mild (n=90, 87)
Title
Measurements
OG00032.2
OG00128.7
Redness- Moderate (n=88, 85)
Title
Measurements
OG0003.4
OG0014.7
Redness- Severe (n=86, 85)
Title
Measurements
OG0000.0
OG0010.0
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).
Units
Counts
Participants
OG00089
OG00189
Title
Denominators
Categories
Tenderness- Any (n=85, 88 )
Title
Measurements
OG00048.2
OG00138.6
Tenderness- Mild (n=85, 84)
Title
Measurements
OG00043.5
OG00131.0
Tenderness- Moderate (n=77, 83)
Title
Measurements
OG00014.3
OG00115.7
Tenderness- Severe (n=73, 77)
Title
Measurements
OG0000.0
OG0011.3
Swelling- Any (n=84, 82)
Title
Measurements
OG00035.7
OG00142.7
Swelling- Mild (n=83, 82)
Title
Measurements
OG00033.7
OG00142.7
Swelling- Moderate (n=75, 76)
Title
Measurements
OG0008.0
OG0012.6
Swelling- Severe (n=73, 76)
Title
Measurements
OG0000.0
OG0010.0
Redness- Any (n=82, 82)
Title
Measurements
OG00028.0
OG00140.2
Redness- Mild (n=82, 82)
Title
Measurements
OG00028.0
OG00137.8
Redness- Moderate (n=73, 76)
Title
Measurements
OG0002.7
OG0012.6
Redness- Severe (n=73, 76)
Title
Measurements
OG0000.0
OG0010.0
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).
Units
Counts
Participants
OG00087
OG00190
Title
Denominators
Categories
Tenderness- Any (n=82, 84)
Title
Measurements
OG00039.0
OG00128.6
Tenderness- Mild (n=81, 84)
Title
Measurements
OG00035.8
OG00126.2
Tenderness- Moderate (n=75, 78)
Title
Measurements
OG0009.3
OG0015.1
Tenderness- Severe (n=73, 77)
Title
Measurements
OG0000.0
OG0010.0
Swelling- Any (n=83, 85)
Title
Measurements
OG00030.1
OG00141.2
Swelling- Mild (n=82, 85)
Title
Measurements
OG00026.8
OG00141.2
Swelling- Moderate (n=75, 79)
Title
Measurements
OG0005.3
OG0015.1
Swelling- Severe (n=73, 77)
Title
Measurements
OG0000.0
OG0010.0
Redness- Any (n=82, 87)
Title
Measurements
OG00032.9
OG00146.0
Redness- Mild (n=82, 87)
Title
Measurements
OG00032.9
OG00146.0
Redness- Moderate (n=74, 79)
Title
Measurements
OG0001.4
OG0013.8
Redness- Severe (n=73, 77)
Title
Measurements
OG0000.0
OG0010.0
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).
Units
Counts
Participants
OG00089
OG00188
Title
Denominators
Categories
Tenderness- Any (n=86, 85)
Title
Measurements
OG00069.8
OG00155.3
Tenderness- Mild (n=86, 85)
Title
Measurements
OG00066.3
OG00151.8
Tenderness- Moderate (n=77, 70)
Title
Measurements
OG00020.8
OG00111.4
Tenderness- Severe (n=74, 69)
Title
Measurements
OG0002.7
OG0010.0
Swelling- Any (n=81, 80)
Title
Measurements
OG00043.2
OG00135.0
Swelling- Mild (n=80, 79)
Title
Measurements
OG00038.8
OG00132.9
Swelling- Moderate (n=76, 74)
Title
Measurements
OG00013.2
OG0019.5
Swelling- Severe (n=74, 69)
Title
Measurements
OG0001.4
OG0010.0
Redness- Any (n=85, 83)
Title
Measurements
OG00051.8
OG00149.4
Redness- Mild (n=85, 83)
Title
Measurements
OG00051.8
OG00148.2
Redness- Moderate (n=75, 75)
Title
Measurements
OG0006.7
OG00110.7
Redness- Severe (n=74, 69)
Title
Measurements
OG0000.0
OG0010.0
OG001
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).
Units
Counts
Participants
OG00098
OG00199
Title
Denominators
Categories
Fever >=38 degrees C (n=86, 88)
Title
Measurements
OG00011.6
OG00113.6
Fever >=38 degrees C, =<39 degrees C (n=86, 88)
Title
Measurements
OG00010.5
OG00113.6
Fever >=39 degrees C, =<40 degrees C (n=86, 85)
Title
Measurements
OG0001.2
OG0010.0
Fever >40 degrees C (n=86, 85)
Title
Measurements
OG0000.0
OG0010.0
Decreased Appetite- Any (n=92, 89)
Title
Measurements
OG00060.9
OG00141.6
Decreased Appetite- Mild (n=91, 88)
Title
Measurements
OG00054.9
OG00135.2
Decreased Appetite- Moderate (n=88, 87)
Title
Measurements
OG00020.5
OG00117.2
Decreased Appetite- Severe (n=86, 85)
Title
Measurements
OG0001.2
OG0010.0
Increased Sleep- Any (n=96, 95)
Title
Measurements
OG00067.7
OG00169.5
Increased Sleep- Mild (n=96, 93)
Title
Measurements
OG00060.4
OG00161.3
Increased Sleep- Moderate (n=87, 88)
Title
Measurements
OG00029.9
OG00130.7
Increased Sleep- Severe (n=86, 85)
Title
Measurements
OG0002.3
OG0012.4
Irritability or Decreased Sleep- Any (n=95, 97)
Title
Measurements
OG00084.2
OG00182.5
Irritability or Decreased Sleep- Mild (n=93, 95)
Title
Measurements
OG00077.4
OG00169.5
Irritability or Decreased Sleep-Moderate (n=92, 91
Title
Measurements
OG00043.5
OG00147.3
Irritability or Decreased Sleep- Severe (n=86, 85)
Title
Measurements
OG0008.1
OG0015.9
Use of Antipyretic Medication (n=90, 90)
Title
Measurements
OG00024.4
OG00124.4
OG001
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).
Units
Counts
Participants
OG00097
OG00196
Title
Denominators
Categories
Fever >=38 degrees C (n=79, 79)
Title
Measurements
OG00027.8
OG00131.6
Fever >=38 degrees C, =<39 degrees C (n=79, 79)
Title
Measurements
OG00027.8
OG00130.4
Fever >=39 degrees C, =<40 degrees C (n=73, 76)
Title
Measurements
OG0000.0
OG0011.3
Fever >40 degrees C (n=73, 76)
Title
Measurements
OG0000.0
OG0010.0
Decreased Appetite- Any (n=89, 84)
Title
Measurements
OG00061.8
OG00146.4
Decreased Appetite- Mild (n=88, 84)
Title
Measurements
OG00055.7
OG00141.7
Decreased Appetite- Moderate (n=79, 78)
Title
Measurements
OG00025.3
OG00119.2
Decreased Appetite- Severe (n=73, 76)
Title
Measurements
OG0001.4
OG0010.0
Increased Sleep- Any (n=85, 89 )
Title
Measurements
OG00074.1
OG00164.0
Increased Sleep- Mild (n=83, 88)
Title
Measurements
OG00069.9
OG00159.1
Increased Sleep- Moderate (n=78, 78)
Title
Measurements
OG00034.6
OG00129.5
Increased Sleep- Severe (n=73, 76)
Title
Measurements
OG0002.7
OG0011.3
Irritability or Decreased Sleep- Any (n=95, 95)
Title
Measurements
OG00089.5
OG00177.9
Irritability or Decreased Sleep- Mild (n=90, 92)
Title
Measurements
OG00081.1
OG00171.7
Irritability or Decreased Sleep-Moderate (n=85, 86
Title
Measurements
OG00064.7
OG00144.2
Irritability or Decreased Sleep- Severe (n=74, 76)
Title
Measurements
OG00017.6
OG0012.6
Use of Antipyretic Medication (n=84, 83)
Title
Measurements
OG00048.8
OG00145.8
OG001
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).
Units
Counts
Participants
OG00094
OG00195
Title
Denominators
Categories
Fever >=38 degrees C (n=79, 81)
Title
Measurements
OG00027.8
OG00130.9
Fever >=38 degrees C, =<39 degrees C (n=78, 81)
Title
Measurements
OG00026.9
OG00130.9
Fever >=39 degrees C, =<40 degrees C (n=75, 78)
Title
Measurements
OG0001.3
OG0012.6
Fever >40 degrees C (n=74, 77)
Title
Measurements
OG0000.0
OG0010.0
Decreased Appetite- Any (n=82, 84)
Title
Measurements
OG00048.8
OG00147.6
Decreased Appetite- Mild (n=82, 84)
Title
Measurements
OG00036.6
OG00146.4
Decreased Appetite- Moderate (n=74, 79)
Title
Measurements
OG00017.6
OG00116.5
Decreased Appetite- Severe (n=74, 77)
Title
Measurements
OG0001.4
OG0011.3
Increased Sleep- Any (n=88, 88 )
Title
Measurements
OG00052.3
OG00158.0
Increased Sleep- Mild (n=88, 87)
Title
Measurements
OG00048.9
OG00151.7
Increased Sleep- Moderate (n=77, 80)
Title
Measurements
OG00016.9
OG00120.0
Increased Sleep- Severe (n=73, 77)
Title
Measurements
OG0001.4
OG0011.3
Irritability or Decreased Sleep- Any (n=92, 95)
Title
Measurements
OG00079.3
OG00181.1
Irritability or Decreased Sleep- Mild (n=90, 91)
Title
Measurements
OG00072.2
OG00174.7
Irritability or Decreased Sleep-Moderate (n=80,87)
Title
Measurements
OG00033.8
OG00135.6
Irritability or Decreased Sleep- Severe (n=74, 78)
Title
Measurements
OG0006.8
OG0016.4
Use of Antipyretic Medication (n=84, 81)
Title
Measurements
OG00040.5
OG00138.3
OG001
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).
Units
Counts
Participants
OG00093
OG00192
Title
Denominators
Categories
Fever >=38 degrees C (n= 80, 78)
Title
Measurements
OG00028.8
OG00143.6
Fever >=38 degrees C, =<39 degrees C (n=80, 77)
Title
Measurements
OG00027.5
OG00142.9
Fever >=39 degrees C, =<40 degrees C (n=74, 71)
Title
Measurements
OG0001.4
OG0014.2
Fever >40 degrees C (n=74, 70)
Title
Measurements
OG0000.0
OG0011.4
Decreased Appetite- Any (n=87, 86)
Title
Measurements
OG00057.5
OG00160.5
Decreased Appetite- Mild (n=86, 84)
Title
Measurements
OG00050.0
OG00156.0
Decreased Appetite- Moderate (n=78, 73)
Title
Measurements
OG00025.6
OG00123.3
Decreased Appetite- Severe (n=75, 69)
Title
Measurements
OG0001.3
OG0011.4
Increased Sleep- Any (n=83, 86 )
Title
Measurements
OG00057.8
OG00165.1
Increased Sleep- Mild (n=82, 84)
Title
Measurements
OG00053.7
OG00159.5
Increased Sleep- Moderate (n=76, 74)
Title
Measurements
OG00018.4
OG00124.3
Increased Sleep- Severe (n=74, 70)
Title
Measurements
OG0000.0
OG0012.9
Irritability or Decreased Sleep- Any (n=90, 91)
Title
Measurements
OG00084.4
OG00180.2
Irritability or Decreased Sleep- Mild (n=90, 89)
Title
Measurements
OG00074.4
OG00176.4
Irritability or Decreased Sleep-Moderate (n=78,80)
Title
Measurements
OG00044.9
OG00145.0
Irritability or Decreased Sleep- Severe (n=76, 69)
Title
Measurements
OG0006.6
OG0014.3
Use of Antipyretic Medication (n=82, 79)
Title
Measurements
OG00048.8
OG00150.6
Units
Counts
Participants
OG000100
OG001100
Title
Denominators
Categories
AEs
Title
Measurements
OG00059.0
OG00155.0
SAEs
Title
Measurements
OG00014.0
OG0015.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.668
2-Sided
Superiority or Other
OG000
OG001
SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.051
2-Sided
Superiority or Other
Units
Counts
Participants
OG000100
OG001100
Title
Denominators
Categories
AEs
Title
Measurements
OG00018.0
OG00115.0
SAEs
Title
Measurements
OG0008.0
OG0019.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.704
2-Sided
Superiority or Other
OG000
OG001
SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
>0.99
2-Sided
Superiority or Other
Units
Counts
Participants
OG00099
OG00197
Title
Denominators
Categories
AEs
Title
Measurements
OG00031.3
OG00126.8
SAEs
Title
Measurements
OG0002.0
OG0011.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.531
2-Sided
Superiority or Other
OG000
OG001
SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
>0.99
2-Sided
Superiority or Other
Units
Counts
Participants
OG00099
OG00197
Title
Denominators
Categories
AEs
Title
Measurements
OG00015.2
OG0018.2
SAEs
Title
Measurements
OG00013.1
OG0018.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.183
2-Sided
Superiority or Other
OG000
OG001
SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.357
2-Sided
Superiority or Other
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
AEs
Title
Measurements
OG0008.0
OG00110.2
SAEs
Title
Measurements
OG0006.8
OG0019.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.794
2-Sided
Superiority or Other
OG000
OG001
SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
Fisher Exact
0.782
2-Sided
Superiority or Other
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).
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 83, 85)
Title
Measurements
OG0008.14(6.61 to 10.04)
OG0019.61(7.77 to 11.88)
6B (n=80, 85)
Title
Measurements
OG0009.46(7.81 to 11.45)
OG0017.61(6.31 to 9.18)
9V (n=83, 85)
Title
Measurements
OG0005.85(5.05 to 6.78)
OG0014.92(4.22 to 5.74)
14 (n=83, 85)
Title
Measurements
OG0004.50(3.76 to 5.38)
OG0014.65(3.82 to 5.65)
18C (n=83, 85)
Title
Measurements
OG0007.36(6.29 to 8.61)
OG0019.14(7.61 to 10.98)
19F (n=83, 85)
Title
Measurements
OG00010.82(8.88 to 13.17)
OG00112.31(9.77 to 15.51)
23F (n=79, 83)
Title
Measurements
OG00010.11(8.13 to 12.57)
OG00110.15(8.32 to 12.39)
1 (n=83, 85)
Title
Measurements
OG0008.41(6.94 to 10.20)
OG0019.98(8.18 to 12.17)
3 (n=81, 84)
Title
Measurements
OG0007.61(5.79 to 10.01)
OG0015.23(4.22 to 6.49)
5 (n=80, 85)
Title
Measurements
OG0003.47(3.04 to 3.97)
OG0013.46(2.93 to 4.09)
6A (n=83, 85)
Title
Measurements
OG00010.52(8.75 to 12.64)
OG0017.72(6.18 to 9.65)
7F (n=83, 85)
Title
Measurements
OG0005.81(5.12 to 6.61)
OG0016.07(5.16 to 7.13)
19A (n=83, 85)
Title
Measurements
OG0006.45(5.39 to 7.72)
OG0015.59(4.53 to 6.90)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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).
GMFR Ratio
0.85
2-Sided
95
0.63
1.14
Superiority or Other
OG000
OG001
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).
GMFR ratio
1.24
2-Sided
95
0.95
1.62
Superiority or Other
OG000
OG001
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).
GMFR ratio
1.19
2-Sided
95
0.96
1.47
Superiority or Other
OG000
OG001
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).
GMFR ratio
0.97
2-Sided
95
0.74
1.26
Superiority or Other
OG000
OG001
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).
GMFR ratio
0.80
2-Sided
95
0.63
1.02
Superiority or Other
OG000
OG001
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).
GMFR ratio
0.88
2-Sided
95
0.65
1.19
Superiority or Other
OG000
OG001
Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.
GMFR ratio
1.00
2-Sided
95
0.74
1.33
Superiority or Other
OG000
OG001
Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.
GMFR ratio
0.84
2-Sided
95
0.64
1.11
Superiority or Other
OG000
OG001
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).
GMFR ratio
1.46
2-Sided
95
1.03
2.05
Superiority or Other
OG000
OG001
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).
GMFR ratio
1.00
2-Sided
95
0.81
1.24
Superiority or Other
OG000
OG001
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).
GMFR ratio
1.36
2-Sided
95
1.02
1.82
Superiority or Other
OG000
OG001
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).
GMFR ratio
0.96
2-Sided
95
0.78
1.18
Superiority or Other
OG000
OG001
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).
GMFR ratio
1.15
2-Sided
95
0.88
1.52
Superiority or Other
OG002
13vPnC Group 1C
Preterm participants with GA <29 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).
Units
Counts
Participants
OG00024
OG00150
OG00225
Title
Denominators
Categories
4 (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG00196.00(86.29 to 99.51)
OG00296.00(79.65 to 99.90)
6B (n=24, 50, 25)
Title
Measurements
OG00079.17(57.85 to 92.87)
OG00172.00(57.51 to 83.77)
OG00268.00(46.50 to 85.05)
9V (n=24, 50, 25)
Title
Measurements
OG00095.83(78.88 to 99.89)
OG00198.00(89.35 to 99.95)
OG00296.00(79.65 to 99.90)
14 (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG001100.00(92.89 to 100.00)
OG002100.00(86.28 to 100.00)
18C (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG00194.00(83.45 to 98.75)
OG002100.00(86.28 to 100.00)
19F (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG00198.00(89.35 to 99.95)
OG002100.00(86.28 to 100.00)
23F (n=24, 50, 25)
Title
Measurements
OG00091.67(73.00 to 98.97)
OG00180.00(66.28 to 89.97)
OG00292.00(73.97 to 99.02)
1 (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG00192.00(80.77 to 97.78)
OG00292.00(73.97 to 99.02)
3 (n=24, 50, 25)
Title
Measurements
OG00087.50(67.64 to 97.34)
OG00186.00(73.26 to 94.18)
OG00284.00(63.92 to 95.46)
5 (n=24, 50, 25)
Title
Measurements
OG00079.17(57.85 to 92.87)
OG00166.00(51.23 to 78.79)
OG00276.00(54.87 to 90.64)
6A (n=24, 49, 25)
Title
Measurements
OG00095.83(78.88 to 99.89)
OG00181.63(67.98 to 91.24)
OG00272.00(50.61 to 87.93)
7F (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG00198.00(89.35 to 99.95)
OG002100.00(86.28 to 100.00)
19A (n=24, 50, 25)
Title
Measurements
OG000100.00(85.75 to 100.00)
OG00198.00(89.35 to 99.95)
OG002100.00(86.28 to 100.00)
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).
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
6B (n=86, 87)
Title
Measurements
OG00097.67(91.85 to 99.72)
OG001100.00(95.85 to 100.00)
9V (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
14 (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
18C (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG00198.85(93.76 to 99.97)
19F (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
23F (n=86, 87)
Title
Measurements
OG00098.84(93.69 to 99.97)
OG001100.00(95.85 to 100.00)
1 (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
3 (n=85, 87)
Title
Measurements
OG00070.59(59.71 to 79.98)
OG00179.31(69.29 to 87.25)
5 (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
6A (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
7F (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
19A (n=86, 87)
Title
Measurements
OG000100.00(95.80 to 100.00)
OG001100.00(95.85 to 100.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
-2.33
2-Sided
95
-8.15
1.96
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
1.15
2-Sided
95
-3.13
6.24
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
-1.16
2-Sided
95
-6.32
3.10
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
-8.72
2-Sided
95
-21.93
4.42
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
OG000
OG001
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.
Percent difference
0.00
2-Sided
95
-4.25
4.31
Superiority or Other
Preterm infant participants with GA <29 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).
Units
Counts
Participants
OG00021
OG00146
OG00221
Title
Denominators
Categories
4 (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
6B (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG00195.56(84.85 to 99.46)
OG002100.00(83.16 to 100.00)
9V (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
14 (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
18C (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
19F (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
23F (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG00197.78(88.23 to 99.94)
OG002100.00(83.16 to 100.00)
1 (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
3 (n=21, 44, 20)
Title
Measurements
OG00095.24(76.18 to 99.88)
OG00168.18(52.42 to 81.39)
OG00250.00(27.20 to 72.80)
5 (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
6A (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
7F (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
19A (n=21, 45, 20)
Title
Measurements
OG000100.00(83.89 to 100.00)
OG001100.00(92.13 to 100.00)
OG002100.00(83.16 to 100.00)
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 85, 85)
Title
Measurements
OG0000.31(0.26 to 0.37)
OG0010.41(0.34 to 0.49)
6B (n= 82, 85)
Title
Measurements
OG0000.48(0.39 to 0.58)
OG0010.94(0.79 to 1.11)
9V (n= 85, 85)
Title
Measurements
OG0000.39(0.33 to 0.46)
OG0010.62(0.53 to 0.72)
14 (n= 85, 85)
Title
Measurements
OG0002.02(1.68 to 2.43)
OG0012.36(1.94 to 2.87)
18C (n=85, 85)
Title
Measurements
OG0000.32(0.28 to 0.37)
OG0010.30(0.26 to 0.36)
19F (n=85, 85)
Title
Measurements
OG0000.68(0.57 to 0.80)
OG0010.93(0.79 to 1.10)
23F (n=81, 83)
Title
Measurements
OG0000.24(0.18 to 0.31)
OG0010.40(0.33 to 0.48)
1 (n=85, 85)
Title
Measurements
OG0000.39(0.34 to 0.46)
OG0010.41(0.35 to 0.48)
3 (n=84, 84)
Title
Measurements
OG0000.07(0.05 to 0.09)
OG0010.11(0.09 to 0.14)
5 (n=82, 85)
Title
Measurements
OG0000.74(0.64 to 0.87)
OG0011.06(0.90 to 1.26)
6A (n=85, 85)
Title
Measurements
OG0000.54(0.45 to 0.65)
OG0011.01(0.82 to 1.24)
7F (n=85, 85)
Title
Measurements
OG0000.72(0.63 to 0.82)
OG0010.84(0.73 to 0.96)
19A (n=85, 85)
Title
Measurements
OG0000.86(0.72 to 1.03)
OG0011.57(1.27 to 1.92)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMC Ratio
0.76
2-Sided
95
0.60
0.97
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.51
2-Sided
95
0.39
0.66
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.64
2-Sided
95
0.51
0.80
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.86
2-Sided
95
0.66
1.12
Superiority or Other
OG000
OG001
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.
GMC Ratio
1.06
2-Sided
95
0.85
1.32
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.73
2-Sided
95
0.58
0.92
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.60
2-Sided
95
0.43
0.83
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.96
2-Sided
95
0.77
1.20
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.60
2-Sided
95
0.41
0.87
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.70
2-Sided
95
0.56
0.88
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.54
2-Sided
95
0.41
0.70
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.86
2-Sided
95
0.71
1.03
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.55
2-Sided
95
0.42
0.72
Superiority or Other
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 86, 87)
Title
Measurements
OG0002.57(2.18 to 3.03)
OG0013.97(3.32 to 4.74)
6B (n=86, 87)
Title
Measurements
OG0004.42(3.64 to 5.37)
OG0017.27(6.09 to 8.68)
9V (n=86, 87)
Title
Measurements
OG0002.30(1.99 to 2.66)
OG0013.06(2.62 to 3.56)
14 (n=86, 87)
Title
Measurements
OG0009.24(7.66 to 11.14)
OG00111.02(9.44 to 12.86)
18C (n=86, 87)
Title
Measurements
OG0002.37(2.02 to 2.79)
OG0012.81(2.32 to 3.40)
19F (n=86, 87)
Title
Measurements
OG0007.38(6.23 to 8.76)
OG00111.67(9.47 to 14.36)
23F (n=86, 87)
Title
Measurements
OG0002.45(2.01 to 2.98)
OG0014.03(3.36 to 4.85)
1 (n=86, 87)
Title
Measurements
OG0003.32(2.83 to 3.89)
OG0014.09(3.42 to 4.89)
3 (n=85, 87)
Title
Measurements
OG0000.52(0.44 to 0.62)
OG0010.57(0.49 to 0.65)
5 (n=86, 87)
Title
Measurements
OG0002.63(2.28 to 3.02)
OG0013.72(3.19 to 4.33)
6A (n=86, 87)
Title
Measurements
OG0005.64(4.86 to 6.54)
OG0017.84(6.59 to 9.33)
7F (n=86, 87)
Title
Measurements
OG0004.25(3.75 to 4.82)
OG0015.13(4.48 to 5.87)
19A (n=86, 87)
Title
Measurements
OG0005.57(4.66 to 6.65)
OG0018.84(7.45 to 10.48)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMC Ratio
0.65
2-Sided
95
0.51
0.82
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.61
2-Sided
95
0.47
0.79
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.75
2-Sided
95
0.61
0.93
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.84
2-Sided
95
0.66
1.07
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.84
2-Sided
95
0.66
1.08
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.63
2-Sided
95
0.48
0.83
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.61
2-Sided
95
0.46
0.79
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.81
2-Sided
95
0.64
1.03
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.92
2-Sided
95
0.73
1.15
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.71
2-Sided
95
0.58
0.87
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.72
2-Sided
95
0.57
0.90
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.83
2-Sided
95
0.69
1.00
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.63
2-Sided
95
0.49
0.81
Superiority or Other
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).
Units
Counts
Participants
OG00080
OG00180
Title
Denominators
Categories
4 (n= 80, 79)
Title
Measurements
OG0000.30(0.25 to 0.36)
OG0010.37(0.31 to 0.44)
6B (n=80, 80)
Title
Measurements
OG0001.26(1.02 to 1.57)
OG0012.01(1.69 to 2.39)
9V (n=80, 80)
Title
Measurements
OG0000.61(0.48 to 0.78)
OG0010.98(0.82 to 1.19)
14 (n=79, 80)
Title
Measurements
OG0001.43(1.15 to 1.78)
OG0011.73(1.40 to 2.14)
18C (n=80, 79)
Title
Measurements
OG0000.33(0.27 to 0.41)
OG0010.66(0.54 to 0.81)
19F (n=80, 79)
Title
Measurements
OG0000.96(0.80 to 1.15)
OG0011.78(1.40 to 2.26)
23F (n=79, 80)
Title
Measurements
OG0000.59(0.47 to 0.74)
OG0011.24(1.01 to 1.52)
1 (n=78, 80)
Title
Measurements
OG0000.40(0.35 to 0.46)
OG0010.53(0.45 to 0.62)
3 (n=78, 78)
Title
Measurements
OG0000.13(0.10 to 0.17)
OG0010.22(0.16 to 0.30)
5 (n=79, 78)
Title
Measurements
OG0001.10(0.91 to 1.32)
OG0011.63(1.35 to 1.97)
6A (n=80, 79)
Title
Measurements
OG0001.08(0.89 to 1.32)
OG0011.59(1.34 to 1.90)
7F (n=79, 80)
Title
Measurements
OG0000.68(0.59 to 0.80)
OG0010.83(0.72 to 0.96)
19A (n=80, 80)
Title
Measurements
OG0001.61(1.22 to 2.12)
OG0013.16(2.53 to 3.95)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMC Ratio
0.81
2-Sided
95
0.63
1.04
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.63
2-Sided
95
0.48
0.83
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.62
2-Sided
95
0.46
0.84
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.83
2-Sided
95
0.61
1.12
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.50
2-Sided
95
0.37
0.67
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.54
2-Sided
95
0.40
0.72
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.47
2-Sided
95
0.35
0.64
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.76
2-Sided
95
0.61
0.94
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.59
2-Sided
95
0.39
0.90
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.67
2-Sided
95
0.52
0.87
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.68
2-Sided
95
0.52
0.88
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.82
2-Sided
95
0.67
1.02
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.51
2-Sided
95
0.36
0.72
Superiority or Other
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).
Units
Counts
Participants
OG00071
OG00171
Title
Denominators
Categories
4 (n=70, 71)
Title
Measurements
OG0000.19(0.16 to 0.23)
OG0010.24(0.20 to 0.29)
6B (n=70, 70)
Title
Measurements
OG0001.44(1.13 to 1.85)
OG0012.70(2.10 to 3.48)
9V (n=71, 70)
Title
Measurements
OG0000.74(0.58 to 0.94)
OG0010.99(0.80 to 1.23)
14 (n=70, 71)
Title
Measurements
OG0001.06(0.78 to 1.43)
OG0011.37(1.03 to 1.82)
18C (n=69, 71)
Title
Measurements
OG0000.32(0.24 to 0.42)
OG0010.57(0.47 to 0.69)
19F (n=71, 70)
Title
Measurements
OG0001.10(0.83 to 1.46)
OG0012.43(1.71 to 3.44)
23F (n=71, 71)
Title
Measurements
OG0001.03(0.77 to 1.38)
OG0011.83(1.42 to 2.37)
1 (n=70, 69)
Title
Measurements
OG0000.32(0.26 to 0.38)
OG0010.39(0.32 to 0.47)
3 (n=65, 63)
Title
Measurements
OG0000.17(0.12 to 0.25)
OG0010.27(0.18 to 0.40)
5 (n=69, 69)
Title
Measurements
OG0001.34(1.07 to 1.68)
OG0011.97(1.60 to 2.41)
6A (n=71, 71)
Title
Measurements
OG0001.41(1.09 to 1.82)
OG0012.10(1.64 to 2.70)
7F (n=71, 70)
Title
Measurements
OG0000.60(0.50 to 0.71)
OG0010.67(0.57 to 0.80)
19A (n=71, 71)
Title
Measurements
OG0002.33(1.76 to 3.10)
OG0014.36(3.40 to 5.61)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMC Ratio
0.80
2-Sided
95
0.61
1.03
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.53
2-Sided
95
0.38
0.76
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.74
2-Sided
95
0.54
1.03
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.77
2-Sided
95
0.51
1.17
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.56
2-Sided
95
0.40
0.78
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.45
2-Sided
95
0.29
0.71
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.56
2-Sided
95
0.38
0.83
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.82
2-Sided
95
0.63
1.07
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.66
2-Sided
95
0.39
1.11
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.68
2-Sided
95
0.50
0.92
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.67
2-Sided
95
0.47
0.95
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.89
2-Sided
95
0.70
1.13
Superiority or Other
OG000
OG001
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.
GMC Ratio
0.53
2-Sided
95
0.37
0.78
Superiority or Other
OG002
13vPnC (Group 1C)
Preterm participants with GA <29 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).
Units
Counts
Participants
OG00024
OG00150
OG00225
Title
Denominators
Categories
4 (n=24, 50, 25)
Title
Measurements
OG0002.50(1.92 to 3.24)
OG0011.86(1.47 to 2.37)
OG0021.73(1.20 to 2.49)
6B (n=24, 50, 25)
Title
Measurements
OG0001.23(0.74 to 2.07)
OG0010.61(0.42 to 0.88)
OG0020.62(0.30 to 1.31)
9V (n=24, 50, 25)
Title
Measurements
OG0001.44(1.02 to 2.03)
OG0011.25(1.02 to 1.53)
OG0021.14(0.78 to 1.65)
14 (n=24, 50, 25)
Title
Measurements
OG0008.95(6.44 to 12.42)
OG0017.13(5.65 to 8.98)
OG0026.95(4.20 to 11.50)
18C (n=24, 50, 25)
Title
Measurements
OG0002.58(1.97 to 3.37)
OG0011.78(1.44 to 2.19)
OG0021.72(1.22 to 2.43)
19F (n=24, 50, 25)
Title
Measurements
OG0002.46(1.77 to 3.43)
OG0012.06(1.67 to 2.55)
OG0022.28(1.61 to 3.24)
23F (n=24, 50, 25)
Title
Measurements
OG0001.38(0.84 to 2.27)
OG0010.65(0.48 to 0.89)
OG0020.95(0.66 to 1.35)
1 (n=24, 50, 25)
Title
Measurements
OG0001.56(1.12 to 2.18)
OG0011.21(0.96 to 1.52)
OG0021.10(0.75 to 1.60)
3 (n=24, 50, 25)
Title
Measurements
OG0001.28(0.86 to 1.90)
OG0010.75(0.60 to 0.93)
OG0020.67(0.49 to 0.91)
5 (n=24, 50, 25)
Title
Measurements
OG0000.85(0.57 to 1.28)
OG0010.50(0.36 to 0.69)
OG0020.46(0.26 to 0.82)
6A (n=24, 49, 25)
Title
Measurements
OG0001.74(1.19 to 2.55)
OG0011.15(0.84 to 1.57)
OG0020.98(0.59 to 1.65)
7F (n=24, 50, 25)
Title
Measurements
OG0002.43(1.56 to 3.77)
OG0011.99(1.61 to 2.46)
OG0022.18(1.55 to 3.06)
19A (n=24, 50, 25)
Title
Measurements
OG0003.43(2.52 to 4.67)
OG0012.60(2.08 to 3.25)
OG0022.88(2.06 to 4.02)
OG002
13vPnC (Group 1C)
Preterm participants with GA <29 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).
Units
Counts
Participants
OG00021
OG00146
OG00221
Title
Denominators
Categories
4 (n= 20, 44, 21)
Title
Measurements
OG0000.37(0.27 to 0.50)
OG0010.28(0.22 to 0.36)
OG0020.32(0.22 to 0.46)
6B (n= 20, 42, 20)
Title
Measurements
OG0000.59(0.42 to 0.83)
OG0010.42(0.31 to 0.56)
OG0020.49(0.30 to 0.80)
9V (n= 20, 44, 21)
Title
Measurements
OG0000.43(0.30 to 0.60)
OG0010.36(0.28 to 0.46)
OG0020.44(0.33 to 0.60)
14 (n=20, 44, 21)
Title
Measurements
OG0002.48(1.74 to 3.54)
OG0011.83(1.40 to 2.38)
OG0022.04(1.33 to 3.12)
18C (n=20, 44, 21)
Title
Measurements
OG0000.35(0.25 to 0.48)
OG0010.30(0.24 to 0.36)
OG0020.34(0.24 to 0.49)
19F (n=20, 44, 21)
Title
Measurements
OG0000.96(0.57 to 1.61)
OG0010.58(0.48 to 0.71)
OG0020.67(0.52 to 0.87)
23F (n=20, 41, 20)
Title
Measurements
OG0000.31(0.19 to 0.52)
OG0010.21(0.14 to 0.32)
OG0020.24(0.14 to 0.41)
1 (n=20, 44, 21)
Title
Measurements
OG0000.37(0.27 to 0.52)
OG0010.39(0.32 to 0.48)
OG0020.42(0.30 to 0.61)
3 (n=20, 44, 20)
Title
Measurements
OG0000.13(0.07 to 0.24)
OG0010.06(0.04 to 0.08)
OG0020.05(0.02 to 0.09)
5 (n=19, 43, 20)
Title
Measurements
OG0000.75(0.56 to 1.01)
OG0010.71(0.55 to 0.90)
OG0020.81(0.62 to 1.06)
6A (n=20, 44, 21)
Title
Measurements
OG0000.66(0.46 to 0.93)
OG0010.49(0.38 to 0.63)
OG0020.55(0.35 to 0.85)
7F (n=20, 44, 21)
Title
Measurements
OG0000.71(0.55 to 0.92)
OG0010.64(0.54 to 0.77)
OG0020.91(0.69 to 1.19)
19A (n=20, 44, 21)
Title
Measurements
OG0001.20(0.76 to 1.89)
OG0010.72(0.57 to 0.91)
OG0020.92(0.66 to 1.30)
OG002
13vPnC (Group 1C)
Preterm participants with GA <29 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).
Units
Counts
Participants
OG00021
OG00146
OG00221
Title
Denominators
Categories
4 (n= 21, 45, 20)
Title
Measurements
OG0003.58(2.66 to 4.83)
OG0012.87(2.29 to 3.59)
OG0021.41(1.05 to 1.88)
6B (n= 21, 45, 20)
Title
Measurements
OG0006.28(4.60 to 8.58)
OG0014.28(3.18 to 5.75)
OG0023.29(2.24 to 4.84)
9V (n= 21, 45, 20)
Title
Measurements
OG0002.99(2.26 to 3.96)
OG0012.23(1.81 to 2.74)
OG0021.88(1.41 to 2.52)
14 (n=21, 45, 20)
Title
Measurements
OG00013.20(9.65 to 18.05)
OG0018.84(6.58 to 11.90)
OG0027.01(5.15 to 9.54)
18C (n=21, 45, 20)
Title
Measurements
OG0003.71(2.77 to 4.97)
OG0012.40(1.95 to 2.96)
OG0021.45(1.05 to 2.00)
19F (n=21, 45, 20)
Title
Measurements
OG00010.45(8.20 to 13.32)
OG0017.39(5.62 to 9.71)
OG0025.12(3.91 to 6.72)
23F (n=21, 45, 20)
Title
Measurements
OG0003.57(2.54 to 5.02)
OG0012.41(1.80 to 3.21)
OG0021.71(1.12 to 2.62)
1 (n=21, 45, 20)
Title
Measurements
OG0004.78(3.61 to 6.34)
OG0013.31(2.62 to 4.18)
OG0022.28(1.74 to 2.99)
3 (n=21, 44, 20)
Title
Measurements
OG0000.88(0.61 to 1.25)
OG0010.51(0.41 to 0.64)
OG0020.31(0.23 to 0.43)
5 (n=21, 45, 20)
Title
Measurements
OG0003.41(2.69 to 4.32)
OG0012.66(2.14 to 3.30)
OG0021.95(1.54 to 2.47)
6A (n=21, 45, 20)
Title
Measurements
OG0006.95(5.18 to 9.33)
OG0015.81(4.68 to 7.22)
OG0024.23(3.22 to 5.56)
7F (n=21, 45, 20)
Title
Measurements
OG0005.29(4.11 to 6.80)
OG0014.09(3.41 to 4.89)
OG0023.69(2.84 to 4.80)
19A (n=21, 45, 20)
Title
Measurements
OG0008.63(6.51 to 11.43)
OG0015.28(3.96 to 7.04)
OG0023.96(3.17 to 4.96)
OG002
13vPnC (Group 1C)
Preterm participants with GA <29 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).
Units
Counts
Participants
OG00018
OG00143
OG00219
Title
Denominators
Categories
4 (n=18, 43, 19)
Title
Measurements
OG0000.30(0.19 to 0.46)
OG0010.29(0.23 to 0.37)
OG0020.32(0.21 to 0.49)
6B (n=18, 43, 19)
Title
Measurements
OG0001.49(0.84 to 2.66)
OG0011.28(0.96 to 1.70)
OG0021.06(0.70 to 1.60)
9V (n=18, 43, 19)
Title
Measurements
OG0000.59(0.37 to 0.93)
OG0010.56(0.42 to 0.75)
OG0020.80(0.40 to 1.59)
14 (n=18, 42, 19)
Title
Measurements
OG0001.37(0.86 to 2.19)
OG0011.38(1.09 to 1.75)
OG0021.62(0.83 to 3.16)
18C (n=18, 43, 19)
Title
Measurements
OG0000.39(0.26 to 0.57)
OG0010.31(0.24 to 0.41)
OG0020.32(0.17 to 0.59)
19F (n=18, 43, 19)
Title
Measurements
OG0001.27(0.81 to 2.00)
OG0010.89(0.70 to 1.14)
OG0020.86(0.62 to 1.21)
23F (n=18, 42, 19)
Title
Measurements
OG0000.79(0.50 to 1.26)
OG0010.54(0.40 to 0.74)
OG0020.53(0.30 to 0.91)
1 (n=18, 41, 19)
Title
Measurements
OG0000.39(0.30 to 0.50)
OG0010.38(0.32 to 0.47)
OG0020.45(0.31 to 0.64)
3 (n=18, 41, 19)
Title
Measurements
OG0000.17(0.10 to 0.29)
OG0010.12(0.09 to 0.17)
OG0020.11(0.05 to 0.23)
5 (n=18, 42, 19)
Title
Measurements
OG0000.87(0.59 to 1.28)
OG0011.24(0.93 to 1.64)
OG0021.05(0.77 to 1.44)
6A (n=18, 43, 19)
Title
Measurements
OG0001.17(0.73 to 1.87)
OG0011.05(0.80 to 1.40)
OG0021.07(0.72 to 1.59)
7F (n=18, 42, 19)
Title
Measurements
OG0000.65(0.47 to 0.91)
OG0010.65(0.52 to 0.81)
OG0020.81(0.61 to 1.08)
19A (n=18, 43, 19)
Title
Measurements
OG0002.12(0.90 to 5.01)
OG0011.50(1.05 to 2.14)
OG0021.45(0.95 to 2.21)
OG002
13vPnC (Group 1C)
Preterm participants with GA <29 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).
Units
Counts
Participants
OG00017
OG00136
OG00218
Title
Denominators
Categories
4 (n=17, 35, 18)
Title
Measurements
OG0000.17(0.11 to 0.28)
OG0010.19(0.16 to 0.24)
OG0020.21(0.13 to 0.33)
6B (n=17, 35, 18)
Title
Measurements
OG0001.39(0.81 to 2.40)
OG0011.81(1.28 to 2.56)
OG0020.96(0.58 to 1.60)
9V (n=17, 36, 18)
Title
Measurements
OG0000.68(0.39 to 1.17)
OG0010.83(0.59 to 1.16)
OG0020.63(0.36 to 1.12)
14 (n=17, 35, 18)
Title
Measurements
OG0001.27(0.59 to 2.76)
OG0011.02(0.71 to 1.48)
OG0020.96(0.47 to 1.96)
18C (n=16, 35, 18)
Title
Measurements
OG0000.34(0.18 to 0.65)
OG0010.35(0.23 to 0.52)
OG0020.26(0.16 to 0.44)
19F (n=17, 36, 18)
Title
Measurements
OG0001.53(0.83 to 2.81)
OG0010.93(0.68 to 1.28)
OG0021.13(0.50 to 2.53)
23F (n=17, 36, 18)
Title
Measurements
OG0001.14(0.60 to 2.15)
OG0011.41(0.95 to 2.09)
OG0020.50(0.27 to 0.90)
1 (n=17, 35, 18)
Title
Measurements
OG0000.32(0.23 to 0.44)
OG0010.35(0.26 to 0.47)
OG0020.26(0.18 to 0.39)
3 (n=16, 33, 16)
Title
Measurements
OG0000.20(0.10 to 0.39)
OG0010.19(0.11 to 0.30)
OG0020.14(0.06 to 0.34)
5 (n=17, 35, 17)
Title
Measurements
OG0001.18(0.67 to 2.11)
OG0011.67(1.25 to 2.25)
OG0020.97(0.62 to 1.50)
6A (n=17, 36, 18)
Title
Measurements
OG0001.32(0.87 to 1.99)
OG0011.58(1.10 to 2.26)
OG0021.20(0.63 to 2.30)
7F (n=17, 36, 18)
Title
Measurements
OG0000.61(0.39 to 0.96)
OG0010.68(0.54 to 0.84)
OG0020.46(0.32 to 0.67)
19A (n=17, 36, 18)
Title
Measurements
OG0003.04(1.64 to 5.64)
OG0012.46(1.69 to 3.58)
OG0021.64(0.83 to 3.23)
Units
Counts
Participants
OG00099
OG00198
Title
Denominators
Categories
4 (n=58, 62)
Title
Measurements
OG0001231(986.5 to 1537.3)
OG001923(746.9 to 1139.7)
6B (n=51, 61)
Title
Measurements
OG000835(478.6 to 1455.2)
OG001732(494.0 to 1086.0)
9V (n=54, 60)
Title
Measurements
OG000151(70.8 to 321.1)
OG001211(108.2 to 413.4)
14 (n=55, 66)
Title
Measurements
OG0001298(968.3 to 1740.3)
OG0011033(735.7 to 1451.0)
18C (n=56, 63)
Title
Measurements
OG0002931(2341.2 to 3669.3)
OG0012057(1594.0 to 2655.1)
19F (n= 55, 58)
Title
Measurements
OG000417(330.7 to 525.8)
OG001335(237.2 to 472.3)
23F (n=55, 60)
Title
Measurements
OG000733(539.3 to 997.3)
OG001582(413.7 to 817.8)
1 (n=88, 87)
Title
Measurements
OG00010(8.0 to 13.4)
OG00113(10.0 to 16.8)
3 (n=83, 86)
Title
Measurements
OG00061(51.2 to 73.2)
OG00157(46.3 to 69.5)
5 (n=83, 85)
Title
Measurements
OG00037(25.9 to 53.9)
OG00164(47.2 to 86.9)
6A (n=88, 88)
Title
Measurements
OG0001566(1312.3 to 1869.0)
OG0011287(980.1 to 1691.1)
7F (n=93, 86)
Title
Measurements
OG0001605(1277.9 to 2014.7)
OG0011539(1297.4 to 1826.3)
19A (n=92, 86)
Title
Measurements
OG000283(232.4 to 344.1)
OG001244(204.1 to 290.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMT Ratio
1.3
2-Sided
95
0.99
1.81
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.1
2-Sided
95
0.59
2.20
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.26
1.93
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.3
2-Sided
95
0.80
1.98
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.4
2-Sided
95
1.01
2.00
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.2
2-Sided
95
0.82
1.89
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.3
2-Sided
95
0.80
1.99
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.8
2-Sided
95
0.56
1.15
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.1
2-Sided
95
0.83
1.41
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.36
0.94
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.2
2-Sided
95
0.88
1.68
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.0
2-Sided
95
0.78
1.39
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.2
2-Sided
95
0.89
1.51
Superiority or Other
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 56, 59)
Title
Measurements
OG00010(6.0 to 15.3)
OG00113(7.9 to 21.9)
6B (n= 59, 62)
Title
Measurements
OG00012(6.8 to 20.1)
OG00115(8.5 to 25.6)
9V (n=52, 63)
Title
Measurements
OG00011(6.2 to 20.9)
OG0017(4.9 to 11.1)
14 (n= 60, 55)
Title
Measurements
OG000242(148.5 to 394.0)
OG001389(260.4 to 582.2)
18C (n= 54, 58)
Title
Measurements
OG00032(16.1 to 61.7)
OG00151(26.8 to 98.3)
19F (n= 57, 60)
Title
Measurements
OG0006(4.1 to 7.4)
OG0014(3.8 to 4.7)
23F (n=59, 62)
Title
Measurements
OG00011(6.9 to 19.0)
OG00116(9.6 to 26.6)
1 (n=76, 80)
Title
Measurements
OG0006(4.5 to 6.8)
OG0014(3.9 to 4.8)
3 (n=73, 77)
Title
Measurements
OG0008(6.2 to 10.0)
OG0018(6.6 to 10.4)
5 (n=74, 79)
Title
Measurements
OG0005(4.2 to 6.0)
OG0015(4.2 to 5.6)
6A (n=69, 76)
Title
Measurements
OG00045(25.2 to 81.1)
OG00191(56.6 to 146.3)
7F (n=75, 79)
Title
Measurements
OG000228(137.6 to 377.1)
OG001188(109.3 to 323.1)
19A (n=77, 79)
Title
Measurements
OG0009(6.3 to 12.0)
OG00110(7.1 to 14.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.37
1.44
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.8
2-Sided
95
0.37
1.71
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.5
2-Sided
95
0.76
3.12
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.33
1.17
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.24
1.55
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.3
2-Sided
95
0.97
1.77
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.35
1.46
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.3
2-Sided
95
1.00
1.60
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.0
2-Sided
95
0.68
1.33
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.0
2-Sided
95
0.82
1.31
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.5
2-Sided
95
0.24
1.04
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.2
2-Sided
95
0.58
2.53
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.8
2-Sided
95
0.52
1.37
Superiority or Other
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 67, 61)
Title
Measurements
OG0001154(879.2 to 1514.5)
OG0011757(1329.1 to 2322.4)
6B (n= 64, 61)
Title
Measurements
OG0001229(877.2 to 1722.1)
OG0011406(1003.4 to 1970.3)
9V (n=60, 58)
Title
Measurements
OG0001871(1217.8 to 2873.6)
OG0012542(1711.6 to 3775.2)
14 (n= 62, 62)
Title
Measurements
OG0001294(969.0 to 1728.4)
OG0011651(1300.1 to 2097.1)
18C (n= 62, 63)
Title
Measurements
OG0002464(1696.0 to 3579.4)
OG0014510(3399.7 to 5981.7)
19F (n= 61, 62)
Title
Measurements
OG000376(229.1 to 617.1)
OG001640(431.5 to 948.3)
23F (n=65, 63)
Title
Measurements
OG0001048(738.6 to 1488.0)
OG0011657(1217.7 to 2255.0)
1 (n=80, 83)
Title
Measurements
OG00059(43.7 to 78.6)
OG001107(83.0 to 137.0)
3 (n=78, 79)
Title
Measurements
OG000114(97.1 to 132.7)
OG001121(103.4 to 140.4)
5 (n=80, 83)
Title
Measurements
OG000166(127.9 to 216.3)
OG001260(203.9 to 331.9)
6A (n=78, 74)
Title
Measurements
OG0001978(1571.5 to 2489.7)
OG0013154(2606.0 to 3816.0)
7F (n=81, 82)
Title
Measurements
OG0002915(2453.4 to 3462.7)
OG0013154(2746.2 to 3622.4)
19A (n=81, 82)
Title
Measurements
OG000558(456.3 to 682.6)
OG001825(692.4 to 983.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.45
0.97
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.9
2-Sided
95
0.54
1.40
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.41
1.31
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.8
2-Sided
95
0.54
1.14
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.5
2-Sided
95
0.34
0.87
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.31
1.10
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.40
1.01
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.5
2-Sided
95
0.38
0.81
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.9
2-Sided
95
0.76
1.17
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.45
0.91
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.47
0.85
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.9
2-Sided
95
0.74
1.15
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.52
0.88
Superiority or Other
Units
Counts
Participants
OG00080
OG00180
Title
Denominators
Categories
4 (n= 66, 59)
Title
Measurements
OG00024(12.9 to 45.5)
OG00129(15.2 to 54.5)
6B (n= 65, 59)
Title
Measurements
OG00038(19.0 to 74.9)
OG00136(19.2 to 68.8)
9V (n=61, 63)
Title
Measurements
OG000141(67.5 to 293.1)
OG001244(126.3 to 469.7)
14 (n= 59, 54)
Title
Measurements
OG000276(169.0 to 449.4)
OG001372(236.1 to 586.5)
18C (n= 62, 60)
Title
Measurements
OG00033(16.4 to 67.4)
OG001121(56.9 to 258.1)
19F (n= 67, 57)
Title
Measurements
OG00011(6.2 to 17.7)
OG00118(9.6 to 35.4)
23F (n=67, 62)
Title
Measurements
OG00045(23.7 to 86.6)
OG001168(92.4 to 303.9)
1 (n=76, 74)
Title
Measurements
OG0005(4.2 to 6.3)
OG0015(4.3 to 5.8)
3 (n=76, 70)
Title
Measurements
OG00011(8.6 to 15.4)
OG00113(9.2 to 18.7)
5 (n=72, 70)
Title
Measurements
OG0008(5.6 to 10.4)
OG00110(7.0 to 13.3)
6A (n=70, 70)
Title
Measurements
OG00098(53.0 to 183.0)
OG001255(152.9 to 424.8)
7F (n=71, 71)
Title
Measurements
OG000599(411.0 to 873.3)
OG001533(348.3 to 814.1)
19A (n=74, 73)
Title
Measurements
OG00028(17.2 to 43.9)
OG00154(34.2 to 85.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMT Ratio
0.8
2-Sided
95
0.35
2.05
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.0
2-Sided
95
0.41
2.63
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.22
1.53
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.38
1.44
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.3
2-Sided
95
0.10
0.76
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.25
1.30
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.3
2-Sided
95
0.11
0.65
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.0
2-Sided
95
0.81
1.32
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.9
2-Sided
95
0.56
1.37
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.8
2-Sided
95
0.51
1.23
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.4
2-Sided
95
0.17
0.86
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.1
2-Sided
95
0.64
1.97
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.5
2-Sided
95
0.27
0.97
Superiority or Other
Units
Counts
Participants
OG00071
OG00171
Title
Denominators
Categories
4 (n= 46, 54)
Title
Measurements
OG00015(7.0 to 32.9)
OG00117(9.0 to 32.6)
6B (n= 56, 48)
Title
Measurements
OG00029(13.7 to 59.9)
OG00127(12.4 to 58.2)
9V (n=50, 55)
Title
Measurements
OG000132(57.5 to 301.5)
OG00175(34.7 to 163.7)
14 (n= 49, 45)
Title
Measurements
OG000262(142.0 to 482.8)
OG001296(161.6 to 543.8)
18C (n= 56, 56)
Title
Measurements
OG00014(7.1 to 25.9)
OG00129(14.3 to 57.9)
19F (n= 60, 58)
Title
Measurements
OG00013(7.4 to 22.5)
OG00120(10.1 to 39.9)
23F (n=58, 59)
Title
Measurements
OG00060(29.7 to 122.2)
OG001135(71.2 to 255.3)
1 (n=70, 68)
Title
Measurements
OG0005(4.1 to 5.4)
OG0014(3.9 to 4.6)
3 (n=69, 66)
Title
Measurements
OG00011(8.1 to 15.2)
OG00116(10.7 to 24.2)
5 (n=68, 69)
Title
Measurements
OG0005(4.1 to 5.6)
OG0017(5.4 to 9.4)
6A (n=68, 62)
Title
Measurements
OG00042(21.5 to 81.1)
OG001102(53.7 to 193.4)
7F (n=64, 65)
Title
Measurements
OG000170(87.7 to 330.9)
OG001269(155.6 to 463.7)
19A (n=68, 67)
Title
Measurements
OG00022(13.6 to 37.1)
OG00150(30.1 to 82.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
GMT Ratio
0.9
2-Sided
95
0.33
2.37
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.1
2-Sided
95
0.37
3.07
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.7
2-Sided
95
0.57
5.36
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.9
2-Sided
95
0.38
2.07
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.5
2-Sided
95
0.18
1.21
Superiority or Other
OG000
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.
GMT Ratio
0.6
2-Sided
95
0.27
1.53
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.4
2-Sided
95
0.17
1.15
Superiority or Other
OG000
OG001
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.
GMT Ratio
1.1
2-Sided
95
0.96
1.31
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.41
1.14
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.7
2-Sided
95
0.49
0.92
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.4
2-Sided
95
0.16
1.03
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.6
2-Sided
95
0.27
1.48
Superiority or Other
OG000
OG001
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.
GMT Ratio
0.5
2-Sided
95
0.22
0.91
Superiority or Other
Units
Counts
Participants
OG00099
OG00198
Title
Denominators
Categories
4 (n= 58, 62)
Title
Measurements
OG000100.00(93.84 to 100.00)
OG001100.00(94.22 to 100.00)
6B (n= 51, 61)
Title
Measurements
OG00090.20(78.59 to 96.74)
OG00195.08(86.29 to 98.97)
9V (n= 54, 60)
Title
Measurements
OG00064.81(50.62 to 77.32)
OG00171.67(58.56 to 82.55)
14 (n= 55, 66)
Title
Measurements
OG000100.00(93.51 to 100.00)
OG00196.97(89.48 to 99.63)
18C (n= 56, 63)
Title
Measurements
OG000100.00(93.62 to 100.00)
OG001100.00(94.31 to 100.00)
19F (n= 55, 58)
Title
Measurements
OG000100.00(93.51 to 100.00)
OG00196.55(88.09 to 99.58)
23F (n= 55, 60)
Title
Measurements
OG00098.18(90.28 to 99.95)
OG00196.67(88.47 to 99.59)
1 (n= 88, 87)
Title
Measurements
OG00040.91(30.54 to 51.91)
OG00151.72(40.75 to 62.58)
3 (n=83, 86)
Title
Measurements
OG000100.00(95.65 to 100.00)
OG00195.35(88.52 to 98.72)
5 (n= 83, 85)
Title
Measurements
OG00067.47(56.30 to 77.35)
OG00183.53(73.91 to 90.69)
6A (n= 88, 88)
Title
Measurements
OG000100.00(95.89 to 100.00)
OG00197.73(92.03 to 99.72)
7F (n= 93, 86)
Title
Measurements
OG00097.85(92.45 to 99.74)
OG001100.00(95.80 to 100.00)
19A (n= 92, 86)
Title
Measurements
OG00098.91(94.09 to 99.97)
OG001100.00(95.80 to 100.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-6.33
5.99
Superiority or Other
OG000
OG001
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.
Percent Difference
-4.89
2-Sided
95
-16.87
5.39
Superiority or Other
OG000
OG001
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.
Percent Difference
-6.85
2-Sided
95
-24.28
10.67
Superiority or Other
OG000
OG001
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.
Percent Difference
3.03
2-Sided
95
-3.68
10.57
Superiority or Other
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-6.57
5.88
Superiority or Other
OG000
OG001
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.
Percent Difference
3.45
2-Sided
95
-3.32
11.91
Superiority or Other
OG000
OG001
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.
Percent Difference
1.52
2-Sided
95
-6.73
9.94
Superiority or Other
OG000
OG001
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.
Perecent Difference
-10.82
2-Sided
95
-25.51
4.34
Superiority or Other
OG000
OG001
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.
Percent Difference
4.65
2-Sided
95
0.04
11.48
Superiority or Other
OG000
OG001
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.
Percent Difference
-16.06
2-Sided
95
-29.15
-2.60
Superiority or Other
OG000
OG001
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.
Percent Difference
2.27
2-Sided
95
-1.96
7.97
Superiority or Other
OG000
OG001
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.
Percent Difference
-2.15
2-Sided
95
-7.55
2.10
Superiority or Other
OG000
OG001
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.
Percent Difference
-1.09
2-Sided
95
-5.96
3.18
Superiority or Other
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n=56, 59)
Title
Measurements
OG00021.43(11.59 to 34.44)
OG00130.51(19.19 to 43.87)
6B (n=59, 62)
Title
Measurements
OG00022.03(12.29 to 34.73)
OG00127.42(16.85 to 40.23)
9V (n=52, 63)
Title
Measurements
OG00019.23(9.63 to 32.53)
OG00112.70(5.65 to 23.50)
14 (n=60, 55)
Title
Measurements
OG00086.67(75.41 to 94.06)
OG00194.55(84.88 to 98.86)
18C (n=54, 58)
Title
Measurements
OG00044.44(30.92 to 58.60)
OG00155.17(41.54 to 68.26)
19F (n=57, 60)
Title
Measurements
OG0008.77(2.91 to 19.30)
OG0011.67(0.04 to 8.94)
23F (n=59, 62)
Title
Measurements
OG00023.73(13.62 to 36.59)
OG00137.10(25.16 to 50.31)
1 (n=76, 80)
Title
Measurements
OG00011.84(5.56 to 21.29)
OG0013.75(0.78 to 10.57)
3 (n=73, 77)
Title
Measurements
OG00032.88(22.33 to 44.87)
OG00140.26(29.23 to 52.06)
5 (n=74, 79)
Title
Measurements
OG0008.11(3.03 to 16.82)
OG0017.59(2.84 to 15.80)
6A (n=69, 76)
Title
Measurements
OG00052.17(39.80 to 64.35)
OG00172.37(60.91 to 82.01)
7F (n=75, 79)
Title
Measurements
OG00078.67(67.68 to 87.29)
OG00173.42(62.28 to 82.73)
19A (n=77, 79)
Title
Measurements
OG00025.97(16.64 to 37.23)
OG00129.11(19.43 to 40.42)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent Difference
-9.08
2-Sided
95
-25.11
7.49
Superiority or Other
OG000
OG001
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.
Percent Difference
-5.39
2-Sided
95
-21.03
10.40
Superiority or Other
OG000
OG001
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.
Percent Difference
6.53
2-Sided
95
-7.16
21.16
Superiority or Other
OG000
OG001
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.
Percent Difference
-7.88
2-Sided
95
-20.28
3.35
Superiority or Other
OG000
OG001
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.
Percent Difference
-10.73
2-Sided
95
-29.01
8.11
Superiority or Other
OG000
OG001
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.
Percent Difference
7.11
2-Sided
95
-1.52
17.65
Superiority or Other
OG000
OG001
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.
Percent Difference
-13.37
2-Sided
95
-29.57
3.31
Superiority or Other
OG000
OG001
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.
Percent Difference
8.09
2-Sided
95
-0.52
17.81
Superiority or Other
OG000
OG001
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.
Percent Difference
-7.38
2-Sided
95
-22.86
8.29
Superiority or Other
OG000
OG001
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.
Percent Difference
0.51
2-Sided
95
-8.82
10.08
Superiority or Other
OG000
OG001
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.
Percent Difference
-20.19
2-Sided
95
-35.45
-3.95
Superiority or Other
OG000
OG001
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.
Percent Difference
5.25
2-Sided
95
-8.50
19.06
Superiority or Other
OG000
OG001
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.
Percent Difference
-3.14
2-Sided
95
-17.51
11.13
Superiority or Other
Units
Counts
Participants
OG00088
OG00188
Title
Denominators
Categories
4 (n= 67, 61)
Title
Measurements
OG000100.00(94.64 to 100.00)
OG001100.00(94.13 to 100.00)
6B (n= 64, 61)
Title
Measurements
OG00098.44(91.60 to 99.96)
OG00198.36(91.20 to 99.96)
9V (n= 60, 58)
Title
Measurements
OG00095.00(86.08 to 98.96)
OG00196.55(88.09 to 99.58)
14 (n= 62, 62)
Title
Measurements
OG000100.00(94.22 to 100.00)
OG001100.00(94.22 to 100.00)
18C (n= 62, 63)
Title
Measurements
OG00098.39(91.34 to 99.96)
OG001100.00(94.31 to 100.00)
19F (n= 61, 62)
Title
Measurements
OG00088.52(77.78 to 95.26)
OG00195.16(86.50 to 98.99)
23F (n= 65, 63)
Title
Measurements
OG00098.46(91.72 to 99.96)
OG00198.41(91.47 to 99.96)
1 (n= 80, 83)
Title
Measurements
OG00087.50(78.21 to 93.84)
OG00193.98(86.50 to 98.02)
3 (n=78, 79)
Title
Measurements
OG000100.00(95.38 to 100.00)
OG00198.73(93.15 to 99.97)
5 (n= 80, 83)
Title
Measurements
OG00096.25(89.43 to 99.22)
OG00197.59(91.57 to 99.71)
6A (n=78, 74)
Title
Measurements
OG000100.00(95.38 to 100.00)
OG001100.00(95.14 to 100.00)
7F (n= 81, 82)
Title
Measurements
OG000100.00(95.55 to 100.00)
OG001100.00(95.60 to 100.00)
19A (n= 81, 82)
Title
Measurements
OG000100.00(95.55 to 100.00)
OG001100.00(95.60 to 100.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-5.59
5.89
Superiority or Other
OG000
OG001
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.
Percent Difference
0.08
2-Sided
95
-6.81
7.37
Superiority or Other
OG000
OG001
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.
Percent Difference
-1.55
2-Sided
95
-10.87
7.44
Superiority or Other
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-5.94
5.94
Superiority or Other
OG000
OG001
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.
Percent Difference
-1.61
2-Sided
95
-8.66
4.25
Superiority or Other
OG000
OG001
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.
Percent Difference
-6.64
2-Sided
95
-17.93
3.56
Superiority or Other
OG000
OG001
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.
Percent Difference
0.05
2-Sided
95
-6.74
7.04
Superiority or Other
OG000
OG001
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.
Percent Difference
-6.48
2-Sided
95
-16.37
2.75
Superiority or Other
OG000
OG001
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.
Percent Difference
1.27
2-Sided
95
-3.37
6.85
Superiority or Other
OG000
OG001
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.
Percent Difference
-1.34
2-Sided
95
-8.36
5.14
Superiority or Other
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-4.73
5.04
Superiority or Other
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-4.48
4.55
Superiority or Other
OG000
OG001
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.
Percent Difference
0.00
2-Sided
95
-4.48
4.55
Superiority or Other
Units
Counts
Participants
OG00080
OG00180
Title
Denominators
Categories
4 (n= 66, 59)
Title
Measurements
OG00034.8(23.5 to 47.6)
OG00142.4(29.6 to 55.9)
6B (n= 65, 59)
Title
Measurements
OG00041.5(29.4 to 54.4)
OG00147.5(34.3 to 60.9)
9V (n= 61, 63)
Title
Measurements
OG00062.3(49.0 to 74.4)
OG00173.0(60.3 to 83.4)
14 (n= 59, 54)
Title
Measurements
OG00086.4(75.0 to 94.0)
OG00190.7(79.7 to 96.9)
18C (n= 62, 60)
Title
Measurements
OG00038.7(26.6 to 51.9)
OG00161.7(48.2 to 73.9)
19F (n= 67, 57)
Title
Measurements
OG00017.9(9.6 to 29.2)
OG00129.8(18.4 to 43.4)
23F (n= 67, 62)
Title
Measurements
OG00049.3(36.8 to 61.8)
OG00177.4(65.0 to 87.1)
1 (n= 76, 74)
Title
Measurements
OG00010.5(4.7 to 19.7)
OG00110.8(4.8 to 20.2)
3 (n=76, 70)
Title
Measurements
OG00047.4(35.8 to 59.2)
OG00148.6(36.4 to 60.8)
5 (n= 72, 70)
Title
Measurements
OG00020.8(12.2 to 32.0)
OG00131.4(20.9 to 43.6)
6A (n=70, 70)
Title
Measurements
OG00062.9(50.5 to 74.1)
OG00181.4(70.3 to 89.7)
7F (n= 71, 71)
Title
Measurements
OG00093.0(84.3 to 97.7)
OG00190.1(80.7 to 95.9)
19A (n= 74, 73)
Title
Measurements
OG00054.1(42.1 to 65.7)
OG00172.6(60.9 to 82.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent Difference
-7.5
2-Sided
95
-24.5
9.9
Superiority or Other
OG000
OG001
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.
Percent Difference
-5.9
2-Sided
95
-23.6
11.8
Superiority or Other
OG000
OG001
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.
Percent Difference
-10.7
2-Sided
95
-27.6
6.0
Superiority or Other
OG000
OG001
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.
Percent Difference
-4.3
2-Sided
95
-17.0
8.4
Superiority or Other
OG000
OG001
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.
Percent Difference
-23.0
2-Sided
95
-40.0
-4.9
Superiority or Other
OG000
OG001
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.
Percent Difference
-11.9
2-Sided
95
-27.4
3.4
Superiority or Other
OG000
OG001
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.
Percent Difference
-28.2
2-Sided
95
-43.9
-11.0
Superiority or Other
OG000
OG001
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.
Percent Difference
-0.3
2-Sided
95
-10.9
10.3
Superiority or Other
OG000
OG001
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.
Percent Difference
-1.2
2-Sided
95
-17.5
15.1
Superiority or Other
OG000
OG001
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.
Percent Difference
-10.6
2-Sided
95
-25.3
4.5
Superiority or Other
OG000
OG001
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.
Percent Difference
-18.6
2-Sided
95
-33.3
-3.0
Superiority or Other
OG000
OG001
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.
Percent Difference
2.8
2-Sided
95
-7.1
13.1
Superiority or Other
OG000
OG001
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.
Percent Difference
-18.5
2-Sided
95
-33.7
-2.8
Superiority or Other
Units
Counts
Participants
OG00071
OG00171
Title
Denominators
Categories
4 (n= 46, 54)
Title
Measurements
OG00021.7(10.9 to 36.4)
OG00129.6(18.0 to 43.6)
6B (n= 56, 48)
Title
Measurements
OG00035.7(23.4 to 49.6)
OG00135.4(22.2 to 50.5)
9V (n= 50, 55)
Title
Measurements
OG00060.0(45.2 to 73.6)
OG00152.7(38.8 to 66.3)
14 (n= 49, 45)
Title
Measurements
OG00081.6(68.0 to 91.2)
OG00184.4(70.5 to 93.5)
18C (n= 56, 56)
Title
Measurements
OG00021.4(11.6 to 34.4)
OG00139.3(26.5 to 53.2)
19F (n= 60, 58)
Title
Measurements
OG00025.0(14.7 to 37.9)
OG00129.3(18.1 to 42.7)
23F (n= 58, 59)
Title
Measurements
OG00053.4(39.9 to 66.7)
OG00174.6(61.6 to 85.0)
1 (n= 70, 68)
Title
Measurements
OG0008.6(3.2 to 17.7)
OG0012.9(0.4 to 10.2)
3 (n=69, 66)
Title
Measurements
OG00046.4(34.3 to 58.8)
OG00151.5(38.9 to 64.0)
5 (n= 68, 69)
Title
Measurements
OG0007.4(2.4 to 16.3)
OG00121.7(12.7 to 33.3)
6A (n=68, 62)
Title
Measurements
OG00044.1(32.1 to 56.7)
OG00164.5(51.3 to 76.3)
7F (n= 64, 65)
Title
Measurements
OG00068.8(55.9 to 79.8)
OG00180.0(68.2 to 88.9)
19A (n= 68, 67)
Title
Measurements
OG00045.6(33.5 to 58.1)
OG00167.2(54.6 to 78.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Percent Difference
-7.9
2-Sided
95
-25.2
9.9
Superiority or Other
OG000
OG001
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.
Percent Difference
0.3
2-Sided
95
-18.5
19.0
Superiority or Other
OG000
OG001
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.
Percent Difference
7.3
2-Sided
95
-12.0
26.2
Superiority or Other
OG000
OG001
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.
Percent Difference
-2.8
2-Sided
95
-19.1
13.3
Superiority or Other
OG000
OG001
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.
Percent Difference
-17.9
2-Sided
95
-34.6
-0.3
Superiority or Other
OG000
OG001
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.
Percent Difference
-4.3
2-Sided
95
-20.6
12.1
Superiority or Other
OG000
OG001
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.
Percent Difference
-21.1
2-Sided
95
-37.8
-3.2
Superiority or Other
OG000
OG001
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.
Percent Difference
5.6
2-Sided
95
-2.7
15.2
Superiority or Other
OG000
OG001
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.
Percent Difference
-5.1
2-Sided
95
-22.0
12.0
Superiority or Other
OG000
OG001
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.
Percent Difference
-14.4
2-Sided
95
-26.7
-2.4
Superiority or Other
OG000
OG001
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.
Percent Difference
-20.4
2-Sided
95
-36.8
-3.0
Superiority or Other
OG000
OG001
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.
Percent Difference
-11.3
2-Sided
95
-26.4
4.1
Superiority or Other
OG000
OG001
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.