Study Evaluating the Safety, Tolerability and Immunogenic... | NCT00574548 | Trialant
NCT00574548
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Jul 22, 2011Estimated
Enrollment
720Actual
Phase
Phase 3
Conditions
Pneumococcal Vaccines
Interventions
13 valent Pneumococcal Conjugate Vaccine
13 valent Pneumococcal Conjugate Vaccine
13 valent Pneumococcal Conjugate Vaccine
23-valent Pneumococcal Polysaccharide Vaccine
23-valent Pneumococcal Polysaccharide Vaccine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00574548
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6115A1-3010
Secondary IDs
ID
Type
Description
Link
B1851027
Brief Title
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
Official Title
A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2011
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
Nov 2007
Primary Completion Date
Feb 2010Actual
Completion Date
Feb 2010Actual
First Submitted Date
Dec 13, 2007
First Submission Date that Met QC Criteria
Dec 13, 2007
First Posted Date
Dec 17, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 1, 2011
Results First Submitted that Met QC Criteria
Apr 15, 2011
Results First Posted Date
May 9, 2011Estimated
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
Jul 18, 2011
Last Update Posted Date
Jul 22, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
Group 1.1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Secondary Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Other Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or Female, aged 60 to 64 years.
Healthy.
Exclusion Criteria:
Previous vaccination with any licensed or experimental pneumococcal vaccine.
History of severe adverse reaction associated with a vaccine.
Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
13 valent Pneumococcal Conjugate Vaccine
Biological
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Group 1.2
13 valent Pneumococcal Conjugate Vaccine
Biological
0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
Group 2
23-valent Pneumococcal Polysaccharide Vaccine
Biological
0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
Group 2
23-valent Pneumococcal Polysaccharide Vaccine
Biological
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Group 1.2
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pembroke Pines
Florida
33024
United States
Pfizer Investigational Site
Boise
Idaho
83704
United States
Pfizer Investigational Site
Raleigh
North Carolina
27609
United States
Pfizer Investigational Site
Cincinnati
Ohio
45229
United States
Pfizer Investigational Site
Bristol
Tennessee
37620
United States
FG001
23vPS - Group 2
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
FG000482 subjects
FG001238 subjects
Received Vaccination 1 (Vax 1)
FG000478 subjects
FG001237 subjects
Completed Vax 1 (6 Month Contact)
FG000468 subjects
FG001234 subjects
Withdrawn After Vax 1 (6 Month Contact)
FG0007 subjects
FG0013 subjects
Withdrawn Before Vax 2
FG00041 subjects
FG00111 subjects
Received Vax 2
FG000427 subjects
FG001223 subjects
Completed Vax 2 (6 Month Contact)
FG000421 subjects
FG001222 subjects
COMPLETED
FG000421 subjects
FG001222 subjects
NOT COMPLETED
FG00061 subjects
FG00116 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC - Group 1.1 or 1.2
Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
BG001
23vPS - Group 2
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000478
BG001237
BG002715
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
years
Title
Denominators
Categories
Title
Measurements
BG00061.7± 1.4
BG00161.7± 1.4
BG00261.7± 1.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000281
BG001134
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
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC / 23vPS
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
OG001
23vPS
23vPS administered as a single dose 0.5 mL IM at Year 0.
Units
Counts
Participants
OG000233
OG001229
Title
Denominators
Categories
Common Serotype 1
Title
Measurements
OG000148(123.7 to 176.5)
OG001148(117.9 to 185.9)
Common Serotype 3
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 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.0
2-Sided
95
0.75
1.33
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
Primary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC / 23vPS
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
OG001
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Units
Counts
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 13vPnC; Year 1) time points.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC Vaccination 1 (Year 0)
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
13vPnC / 13vPnC Vaccination 2 (Year 1)
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC Vaccination 1 (Year 0)
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
13vPnC / 23vPS Vaccination 2 (Year 1)
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
23vPS
23vPS administered as a single dose 0.5 mL IM at Year 0.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
13vPnC / 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
23vPS
23vPS administered as a single dose 0.5 mL IM at Year 0.
OG001
13vPnC / 23vPS
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC / 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
OG001
13vPnC / 23vPS
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
23vPS
23vPS administered as a single dose 0.5 mL IM at Year 0.
Units
Counts
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
13vPnC / 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
OG001
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
23vPS
23vPS administered as a single dose 0.5 mL IM at Year 0.
OG001
13vPnC / 23vPS
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
ID
Title
Description
OG000
13vPnC / 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
OG001
13vPnC / 23vPS
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
Time Frame
Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Description
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
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 (Year 0)
Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163.
2
478
256
478
EG001
23vPS (Year 0)
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86.
1
237
102
237
EG002
13vPnC: 6 Month Follow-up After Vax 1 (Year 0)
Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
15
478
41
478
EG003
23vPS: 6 Month Follow-up After Vax 1 (Year 0)
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
6
237
24
237
EG004
13vPnC / 13vPnC (Year 1)
13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54.
0
160
97
160
EG005
13vPnC / 23vPS (Year 1)
13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120.
2
267
198
267
EG006
23vPS / 13vPnC (Year 1)
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68.
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.
Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.6
2-Sided
95
1.24
1.94
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.0
2-Sided
95
0.74
1.41
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.4
2-Sided
95
1.01
2.00
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.7
2-Sided
95
1.18
2.51
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.6
2-Sided
95
1.07
2.47
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.3
2-Sided
95
0.79
2.12
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
0.8
2-Sided
95
0.58
1.25
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.3
2-Sided
95
0.94
1.93
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.2
2-Sided
95
0.96
1.61
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.09
2.12
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.8
2-Sided
95
1.86
4.35
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
Participants
OG000233
OG001196
Title
Denominators
Categories
Common Serotype 1
Title
Measurements
OG000148(123.7 to 176.5)
OG00177(60.7 to 98.1)
Common Serotype 3
Title
Measurements
OG000125(108.6 to 143.4)
OG00150(40.9 to 61.7)
Common Serotype 4
Title
Measurements
OG0001385(1171.2 to 1638.7)
OG001935(739.9 to 1182.4)
Common Serotype 5
Title
Measurements
OG000199(161.4 to 246.2)
OG00185(64.2 to 112.0)
Common Serotype 6B
Title
Measurements
OG0001215(965.4 to 1528.3)
OG001710(529.1 to 953.2)
Common Serotype 7F
Title
Measurements
OG000537(422.4 to 682.6)
OG001126(85.6 to 184.6)
Common Serotype 9V
Title
Measurements
OG000373(268.4 to 517.6)
OG001114(76.5 to 169.3)
Common Serotype 14
Title
Measurements
OG000622(485.7 to 796.4)
OG001435(323.0 to 585.7)
Common Serotype 18C
Title
Measurements
OG0001062(863.2 to 1307.6)
OG001564(418.2 to 761.7)
Common Serotype 19A
Title
Measurements
OG000467(403.5 to 541.0)
OG001289(235.7 to 353.9)
Common Serotype 19F
Title
Measurements
OG000774(642.0 to 933.6)
OG001286(217.3 to 376.7)
Common Serotype 23F
Title
Measurements
OG000198(151.2 to 259.4)
OG001124(88.2 to 173.0)
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
Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.9
2-Sided
95
1.43
2.57
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.5
2-Sided
95
1.95
3.16
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.12
1.96
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.4
2-Sided
95
1.67
3.31
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.7
2-Sided
95
1.19
2.47
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
4.3
2-Sided
95
2.76
6.61
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
3.3
2-Sided
95
1.97
5.45
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.4
2-Sided
95
0.98
2.10
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.9
2-Sided
95
1.32
2.69
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.6
2-Sided
95
1.27
2.07
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.7
2-Sided
95
1.96
3.74
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.6
2-Sided
95
1.05
2.45
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS / 13vPnC]).
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).
Units
Counts
Participants
OG000127
OG001127
Title
Denominators
Categories
Common Serotype 1
Title
Measurements
OG000215(163.9 to 282.4)
OG001142(112.2 to 180.4)
Common Serotype 3
Title
Measurements
OG00073(57.2 to 94.1)
OG00189(75.2 to 105.4)
Common Serotype 4
Title
Measurements
OG0002255(1625.2 to 3128.6)
OG0011214(931.8 to 1582.1)
Common Serotype 5
Title
Measurements
OG000170(112.1 to 258.6)
OG00198(69.6 to 136.6)
Additional Serotype 6A
Title
Measurements
OG0002682(1969.5 to 3652.1)
OG0012281(1747.1 to 2978.5)
Common Serotype 6B
Title
Measurements
OG0002112(1508.0 to 2958.2)
OG0011882(1429.7 to 2477.9)
Common Serotype 7F
Title
Measurements
OG000930(602.1 to 1437.1)
OG001323(215.8 to 482.8)
Common Serotype 9V
Title
Measurements
OG000919(619.1 to 1364.0)
OG001335(214.6 to 522.6)
Common Serotype 14
Title
Measurements
OG000492(312.7 to 774.5)
OG001384(262.4 to 561.2)
Common Serotype 18C
Title
Measurements
OG0001440(1015.3 to 2043.5)
OG001986(730.8 to 1330.2)
Common Serotype 19A
Title
Measurements
OG000583(426.6 to 796.8)
OG001385(308.2 to 481.6)
Common Serotype 19F
Title
Measurements
OG000566(385.7 to 829.2)
OG001502(381.3 to 662.1)
Common Serotype 23F
Title
Measurements
OG000291(187.7 to 452.2)
OG001456(322.4 to 644.7)
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 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.7
2-Sided
95
0.54
0.82
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
1.2
2-Sided
95
0.99
1.49
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.5
2-Sided
95
0.43
0.68
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.6
2-Sided
95
0.43
0.77
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.9
2-Sided
95
0.67
1.08
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.9
2-Sided
95
0.71
1.12
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.3
2-Sided
95
0.24
0.49
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.4
2-Sided
95
0.26
0.51
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.8
2-Sided
95
0.60
1.02
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.7
2-Sided
95
0.54
0.87
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.7
2-Sided
95
0.53
0.82
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.9
2-Sided
95
0.69
1.15
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
1.6
2-Sided
95
1.15
2.13
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
Units
Counts
Participants
OG000221
OG001221
Title
Denominators
Categories
Common Serotype 1
Title
Measurements
OG000220(178.9 to 269.3)
OG001140(117.4 to 168.1)
Common Serotype 3
Title
Measurements
OG00074(61.3 to 88.7)
OG001129(112.4 to 147.5)
Common Serotype 4
Title
Measurements
OG0002517(2091.7 to 3029.2)
OG0011430(1214.7 to 1683.9)
Common Serotype 5
Title
Measurements
OG000227(170.9 to 300.5)
OG001188(151.1 to 234.8)
Common Serotype 6B
Title
Measurements
OG0002012(1571.9 to 2574.1)
OG0011351(1087.6 to 1677.0)
Common Serotype 7F
Title
Measurements
OG0001252(971.1 to 1614.4)
OG001533(419.2 to 678.2)
Common Serotype 9V
Title
Measurements
OG000758(563.8 to 1018.9)
OG001406(292.3 to 564.6)
Common Serotype 14
Title
Measurements
OG000664(485.1 to 908.5)
OG001616(473.3 to 802.2)
Common Serotype 18C
Title
Measurements
OG0001532(1183.7 to 1982.7)
OG0011074(871.7 to 1322.2)
Common Serotype 19A
Title
Measurements
OG000696(581.1 to 833.6)
OG001457(389.5 to 536.3)
Common Serotype 19F
Title
Measurements
OG000696(546.3 to 887.7)
OG001773(636.6 to 937.6)
Common Serotype 23F
Title
Measurements
OG000358(265.5 to 481.7)
OG001216(165.0 to 282.7)
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 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.6
2-Sided
95
0.55
0.75
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
1.7
2-Sided
95
1.52
2.01
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.6
2-Sided
95
0.49
0.66
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.8
2-Sided
95
0.67
1.03
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.7
2-Sided
95
0.57
0.79
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.4
2-Sided
95
0.35
0.52
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.5
2-Sided
95
0.41
0.69
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.9
2-Sided
95
0.75
1.15
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.7
2-Sided
95
0.58
0.85
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.7
2-Sided
95
0.58
0.74
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
1.1
2-Sided
95
0.89
1.39
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000
OG001
Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.
Geometric mean fold rise
0.6
2-Sided
95
0.50
0.73
CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Yes
Non-Inferiority or Equivalence
Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.
OG000455
OG001196
Title
Denominators
Categories
Common Serotype 1
Title
Measurements
OG000207(177.7 to 240.9)
OG00177(60.7 to 98.1)
Common Serotype 3
Title
Measurements
OG00075(66.0 to 85.3)
OG00150(40.9 to 61.7)
Common Serotype 4
Title
Measurements
OG0002536(2192.3 to 2933.0)
OG001935(739.9 to 1182.4)
Common Serotype 5
Title
Measurements
OG000215(175.9 to 261.7)
OG00185(64.2 to 112.0)
Common Serotype 6B
Title
Measurements
OG0001948(1614.0 to 2351.7)
OG001710(529.1 to 953.2)
Common Serotype 7F
Title
Measurements
OG0001063(868.6 to 1302.2)
OG001126(85.6 to 184.6)
Common Serotype 9V
Title
Measurements
OG000767(620.0 to 949.3)
OG001114(76.5 to 169.3)
Common Serotype 14
Title
Measurements
OG000650(524.9 to 805.8)
OG001435(323.0 to 585.7)
Common Serotype 18C
Title
Measurements
OG0001576(1321.3 to 1880.9)
OG001564(418.2 to 761.7)
Common Serotype 19A
Title
Measurements
OG000709(618.9 to 811.2)
OG001289(235.7 to 353.9)
Common Serotype 19F
Title
Measurements
OG000711(595.9 to 848.9)
OG001286(217.3 to 376.7)
Common Serotype 23F
Title
Measurements
OG000354(283.8 to 440.7)
OG001124(88.2 to 173.0)
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
Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.7
2-Sided
95
2.03
3.55
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.18
1.89
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.7
2-Sided
95
2.07
3.55
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.5
2-Sided
95
1.77
3.61
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.7
2-Sided
95
1.94
3.88
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
8.5
2-Sided
95
5.68
12.60
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
6.7
2-Sided
95
4.45
10.22
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.02
2.18
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.8
2-Sided
95
2.01
3.89
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.5
2-Sided
95
1.92
3.13
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.5
2-Sided
95
1.80
3.44
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
OG000
OG001
Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.9
2-Sided
95
1.92
4.28
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] - [23vPS / 13vPnC]).
No
Superiority or Other
Units
Counts
Participants
OG000374
OG001180
Title
Denominators
Categories
Redness: Any (n=270, 134)
Title
Measurements
OG00012.2
OG00111.2
Redness: Mild (n=266, 134)
Title
Measurements
OG0008.3
OG0019.7
Redness: Moderate (n=264, 128)
Title
Measurements
OG0006.4
OG0013.9
Redness: Severe (n=259, 127)
Title
Measurements
OG0001.2
OG0010.8
Swelling: Any (n=270, 135)
Title
Measurements
OG00010.0
OG00110.4
Swelling: Mild (n=268, 132)
Title
Measurements
OG0008.2
OG0016.1
Swelling: Moderate (n=263, 132)
Title
Measurements
OG0003.8
OG0017.6
Swelling: Severe (n=258, 127)
Title
Measurements
OG0000.0
OG0010.0
Pain: Any (n=370, 175)
Title
Measurements
OG00069.2
OG00158.3
Pain: Mild (n=360, 170)
Title
Measurements
OG00066.1
OG00152.9
Pain: Moderate (n=284, 143)
Title
Measurements
OG00020.1
OG00121.7
Pain: Severe (n=261, 127)
Title
Measurements
OG0002.3
OG0010.8
Limitation of arm movement: Any (n=289, 142)
Title
Measurements
OG00023.5
OG00128.2
Limitation of arm movement: Mild (n=286, 142)
Title
Measurements
OG00022.7
OG00126.1
Limitation of arm movement: Moderate (n=260, 127)
Title
Measurements
OG0001.2
OG0013.1
Limitation of arm movement: Severe (n=261, 128)
Title
Measurements
OG0001.1
OG0012.3
Units
Counts
Participants
OG000110
OG001110
Title
Denominators
Categories
Redness: Any (n=61, 61)
Title
Measurements
OG00014.8
OG00111.5
Redness: Mild (n=57, 57)
Title
Measurements
OG0007.0
OG0018.8
Redness: Moderate (n=58, 58)
Title
Measurements
OG0008.6
OG0013.4
Redness: Severe (n=57, 57)
Title
Measurements
OG0000.0
OG0013.5
Swelling: Any (n=60, 60)
Title
Measurements
OG00010.0
OG00111.7
Swelling: Mild (n=59, 59)
Title
Measurements
OG0006.8
OG0018.5
Swelling: Moderate (n=55, 55)
Title
Measurements
OG0001.8
OG0013.6
Swelling: Severe (n=56, 56)
Title
Measurements
OG0000.0
OG0011.8
Pain: Any (n=108, 108)
Title
Measurements
OG00076.9
OG00175.9
Pain: Mild (n=101, 101)
Title
Measurements
OG00072.3
OG00172.3
Pain: Moderate (n=61, 61)
Title
Measurements
OG00021.3
OG00126.2
Pain: Severe (n=57, 57)
Title
Measurements
OG0000.0
OG0013.5
Limitation of arm movement: Any (n=65, 65)
Title
Measurements
OG00026.2
OG00124.6
Limitation of arm movement: Mild (n=65, 65)
Title
Measurements
OG00026.2
OG00124.6
Limitation of arm movement: Moderate (n=56, 56)
Title
Measurements
OG0001.8
OG0010.0
Limitation of arm movement: Severe (n=56, 56)
Title
Measurements
OG0000.0
OG0011.8
Units
Counts
Participants
OG000374
OG001171
Title
Denominators
Categories
Redness: Any (n=270, 115)
Title
Measurements
OG00012.2
OG0014.3
Redness: Mild (n=266, 115)
Title
Measurements
OG0008.3
OG0014.3
Redness: Moderate (n=264, 115)
Title
Measurements
OG0006.4
OG0010.9
Redness: Severe (n=259, 115)
Title
Measurements
OG0001.2
OG0010.0
Swelling: Any (n=270, 119)
Title
Measurements
OG00010.0
OG0015.0
Swelling: Mild (n=268, 119)
Title
Measurements
OG0008.2
OG0015.0
Swelling: Moderate (n=263, 116)
Title
Measurements
OG0003.8
OG0010.9
Swelling: Severe (n=258, 115)
Title
Measurements
OG0000.0
OG0010.0
Pain: Any (n=370, 169)
Title
Measurements
OG00069.2
OG00169.8
Pain: Mild (n=360, 166)
Title
Measurements
OG00066.1
OG00168.1
Pain: Moderate (n=284, 129)
Title
Measurements
OG00020.1
OG00117.8
Pain: Severe (n=261, 116)
Title
Measurements
OG0002.3
OG0010.9
Limitation of arm movement: Any (n=289, 130)
Title
Measurements
OG00023.5
OG00118.5
Limitation of arm movement: Mild (n=286, 130)
Title
Measurements
OG00022.7
OG00116.9
Limitation of arm movement: Moderate (n=260, 115)
Title
Measurements
OG0001.2
OG0010.0
Limitation of arm movement: Severe (n=261, 115)
Title
Measurements
OG0001.1
OG0011.7
Units
Counts
Participants
OG000180
OG001234
Title
Denominators
Categories
Redness: Any (n=134, 151)
Title
Measurements
OG00011.2
OG00127.8
Redness: Mild (n=134, 144)
Title
Measurements
OG0009.7
OG00119.4
Redness: Moderate (n=128, 138)
Title
Measurements
OG0003.9
OG00112.3
Redness: Severe (n=127, 131)
Title
Measurements
OG0000.8
OG0016.9
Swelling: Any (n=135, 155)
Title
Measurements
OG00010.4
OG00125.8
Swelling: Mild (n=132, 149)
Title
Measurements
OG0006.1
OG00120.1
Swelling: Moderate (n=132, 138)
Title
Measurements
OG0007.6
OG00112.3
Swelling: Severe (n=127, 132)
Title
Measurements
OG0000.0
OG0016.1
Pain: Any (n=175, 231)
Title
Measurements
OG00058.3
OG00185.7
Pain: Mild (n=170, 205)
Title
Measurements
OG00052.9
OG00178.5
Pain: Moderate (n=143, 176)
Title
Measurements
OG00021.7
OG00149.4
Pain: Severe (n=127, 140)
Title
Measurements
OG0000.8
OG00112.9
Limitation of arm movement: Any (n=142, 178)
Title
Measurements
OG00028.2
OG00153.4
Limitation of arm movement: Mild (n=142, 171)
Title
Measurements
OG00026.1
OG00147.4
Limitation of arm movement: Moderate (n=127, 134)
Title
Measurements
OG0003.1
OG00110.4
Limitation of arm movement: Severe (n=128, 135)
Title
Measurements
OG0002.3
OG0018.1
OG002
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Units
Counts
Participants
OG000130
OG001234
OG002171
Title
Denominators
Categories
Redness: Any (n=86, 151, 115)
Title
Measurements
OG00012.8
OG00127.8
OG0024.3
Redness: Mild (n=83, 144, 115)
Title
Measurements
OG0007.2
OG00119.4
OG0024.3
Redness: Moderate (n=83, 138, 115)
Title
Measurements
OG0007.2
OG00112.3
OG0020.9
Redness: Severe (n=83, 131, 115)
Title
Measurements
OG0002.4
OG0016.9
OG0020.0
Swelling: Any (n=86, 155, 119)
Title
Measurements
OG00014.0
OG00125.8
OG0025.0
Swelling: Mild (n=85, 149, 119)
Title
Measurements
OG00010.6
OG00120.1
OG0025.0
Swelling: Moderate (n=82, 138, 116)
Title
Measurements
OG0006.1
OG00112.3
OG0020.9
Swelling: Severe (n=82, 132, 115)
Title
Measurements
OG0001.2
OG0016.1
OG0020.0
Pain: Any (n=129, 231, 169)
Title
Measurements
OG00075.2
OG00185.7
OG00269.8
Pain: Mild (n=123, 205, 166)
Title
Measurements
OG00072.4
OG00178.5
OG00268.1
Pain: Moderate (n=91, 176, 129)
Title
Measurements
OG00024.2
OG00149.4
OG00217.8
Pain: Severe (n=83, 140, 116)
Title
Measurements
OG0002.4
OG00112.9
OG0020.9
Limitation of arm movement: Any (n=93, 178, 130)
Title
Measurements
OG00028.0
OG00153.4
OG00218.5
Limitation of arm movement: Mild (n=92, 171, 130)
Title
Measurements
OG00027.2
OG00147.4
OG00216.9
Limitation of arm movement: Moderate(n=83,134,115)
Title
Measurements
OG0003.6
OG00110.4
OG0020.0
Limitation of arm movement: Severe (n=82, 135,115)
Title
Measurements
OG0001.2
OG0018.1
OG0021.7
Participants
OG000383
OG001202
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=263, 127)
Title
Measurements
OG0004.6
OG0011.6
Fever: Mild ≥38 but <38.5 degrees C (n=263, 127)
Title
Measurements
OG0003.8
OG0010.8
Fever: Moderate ≥38.5 but <39 degrees C(n=259,127)
Title
Measurements
OG0000.8
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C (n=259, 127)
Title
Measurements
OG0000.4
OG0010.8
Fever Potentially life threatening >40C(n=258,127)
Title
Measurements
OG0000.4
OG0010.0
Fatigue (n=321, 173)
Title
Measurements
OG00050.5
OG00149.1
Headache (n=328, 167)
Title
Measurements
OG00049.7
OG00146.1
Chills (n=286, 145)
Title
Measurements
OG00019.9
OG00126.9
Rash (n=267, 134)
Title
Measurements
OG0008.6
OG00113.4
Vomiting (n=261, 131)
Title
Measurements
OG0003.1
OG0013.1
Decreased appetite (n=278, 148)
Title
Measurements
OG00014.7
OG00123.0
New muscle pain (n=324, 167)
Title
Measurements
OG00046.9
OG00151.5
Aggravated muscle pain (n=286, 154)
Title
Measurements
OG00022.0
OG00132.5
New joint pain (n=278, 147)
Title
Measurements
OG00015.5
OG00123.81
Aggravated joint pain (n=272, 142)
Title
Measurements
OG00014.0
OG00121.1
Units
Counts
Participants
OG000102
OG001102
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=55, 55)
Title
Measurements
OG0009.1
OG0013.6
Fever: Mild ≥38 but <38.5 degrees C (n=55, 55)
Title
Measurements
OG0007.3
OG0010.0
Fever: Moderate ≥38.5 but <39 degrees C(n=55, 55)
Title
Measurements
OG0000.0
OG0011.8
Fever: Severe ≥39 but ≤40 degrees C (n=55, 55)
Title
Measurements
OG0000.0
OG0010.0
Fever Potentially life threatening >40C (n=55, 55)
Title
Measurements
OG0001.8
OG0011.8
Fatigue (n=76, 76)
Title
Measurements
OG00056.6
OG00143.4
Headache (n=76, 76)
Title
Measurements
OG00052.6
OG00144.7
Chills (n=61, 61)
Title
Measurements
OG00018.0
OG00119.7
Rash (n=60, 60)
Title
Measurements
OG0008.3
OG00110.0
Vomiting (n=56, 56)
Title
Measurements
OG0007.1
OG0013.6
Decreased appetite (n=61, 61)
Title
Measurements
OG00013.1
OG00121.3
New muscle pain (n=84, 84)
Title
Measurements
OG00047.6
OG00151.2
Aggravated muscle pain (n=68, 68)
Title
Measurements
OG00026.5
OG00130.9
New joint pain (n=62, 62)
Title
Measurements
OG00014.5
OG00116.1
Aggravated joint pain (n=62, 62)
Title
Measurements
OG00016.1
OG00119.4
Units
Counts
Participants
OG000383
OG001169
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=263, 116)
Title
Measurements
OG0004.6
OG0010.9
Fever: Mild ≥38 but <38.5 degrees C (n=263, 116)
Title
Measurements
OG0003.8
OG0010.9
Fever: Moderate ≥38.5 but <39 degrees C(n=259,115)
Title
Measurements
OG0000.8
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C(n=259,115)
Title
Measurements
OG0000.4
OG0010.0
Fever Potentially life threatening >40C(n=258,115)
Title
Measurements
OG0000.4
OG0010.0
Fatigue (n=321, 141)
Title
Measurements
OG00050.5
OG00141.1
Headache (n=328, 139)
Title
Measurements
OG00049.7
OG00140.3
Chills (n=286, 127)
Title
Measurements
OG00019.9
OG00119.7
Rash (n=267, 121)
Title
Measurements
OG0008.6
OG0018.3
Vomiting (n=261, 118)
Title
Measurements
OG0003.1
OG0016.8
Decreased appetite (n=278, 123)
Title
Measurements
OG00014.7
OG00113.0
New muscle pain (n=324, 151)
Title
Measurements
OG00046.9
OG00145.0
Aggravated muscle pain (n=286, 136)
Title
Measurements
OG00022.0
OG00128.7
New joint pain (n=278, 128)
Title
Measurements
OG00015.5
OG00119.5
Aggravated joint pain (n=272, 131)
Title
Measurements
OG00014.0
OG00121.4
Units
Counts
Participants
OG000202
OG001175
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=127, 129)
Title
Measurements
OG0001.6
OG0013.1
Fever: Mild ≥38 but <38.5 degrees C (n=127, 129)
Title
Measurements
OG0000.8
OG0013.1
Fever: Moderate ≥38.5 but <39 degrees C(n=127,127)
Title
Measurements
OG0000.0
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C(n=127,127)
Title
Measurements
OG0000.8
OG0010.0
Fever Potentially life threatening >40C(n=127,127)
Title
Measurements
OG0000.0
OG0010.0
Fatigue (n=173, 185)
Title
Measurements
OG00049.1
OG00151.9
Headache (n=167, 175)
Title
Measurements
OG00046.1
OG00149.7
Chills (n=145, 155)
Title
Measurements
OG00026.9
OG00129.0
Rash (n=134, 146)
Title
Measurements
OG00013.4
OG00124.0
Vomiting (n=131, 131)
Title
Measurements
OG0003.1
OG0014.6
Decreased appetite (n=148, 141)
Title
Measurements
OG00023.0
OG00117.0
New muscle pain (n=167, 196)
Title
Measurements
OG00051.5
OG00161.2
Aggravated muscle pain (n=154, 164)
Title
Measurements
OG00032.5
OG00141.5
New joint pain (n=147, 153)
Title
Measurements
OG00023.8
OG00125.5
Aggravated joint pain (n=142, 143)
Title
Measurements
OG00021.1
OG00117.5
OG002
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Units
Counts
Participants
OG000117
OG001222
OG002169
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=81, 129, 116)
Title
Measurements
OG0002.5
OG0013.1
OG0020.9
Fever: Mild ≥38 but <38.5 degrees C (n=81,129,116)