Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Official Title
A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2021
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
Feb 27, 2007Actual
Primary Completion Date
Aug 1, 2011Actual
Completion Date
Aug 1, 2011Actual
First Submitted Date
Jan 25, 2007
First Submission Date that Met QC Criteria
Jan 26, 2007
First Posted Date
Jan 29, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 1, 2012
Results First Submitted that Met QC Criteria
Aug 1, 2012
Results First Posted Date
Sep 5, 2012Estimated
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
Nov 11, 2021
Last Update Posted Date
Nov 15, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
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
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
Detailed Description
Not provided
Conditions Module
Conditions
Pneumococcal Infections
Keywords
Vaccine
Pneumococcal Infections Prevention and Control
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,141Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
13vPnC Cohort 1, Vaccination 1
Experimental
Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
One month after vaccination 1
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
One month after vaccination 1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 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).
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.
Exclusion Criteria:
Previous immunization with any licensed or experimental pneumococcal vaccine.
Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which in the investigator's opinion precludes the subject from participating in the study.
Known or suspected impairment of immunological function.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
64 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Accelovance
Huntsville
Alabama
35802
United States
East Valley Family Physicians, PLC
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Participants in Cohort 1 and 2 participated for 1 year in the study. Vaccination 2 (3 to 4 years after vaccination 1) was administered to participants in Cohort 1 and 2. Participants in Cohort 3 enrolled as part of amendment 3 participated for 6 months and participants in Cohort 3 enrolled as part of amendment 4 participated for 1 year in study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at baseline.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Within 14 days after vaccination 2
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.
Within 14 days after vaccination 2
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 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 [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Within 14 days after vaccination 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Within 14 days after vaccination 1
Chandler
Arizona
85224
United States
Clinical Research Advantage/Central Phoenix
Phoenix
Arizona
85020
United States
University Clinical Research, Inc.
Pembroke Pines
Florida
33024
United States
Advanced Clinical Research
Meridian
Idaho
83642
United States
Accelovance
South Bend
Indiana
46601
United States
Heartland Research Associates LLC
Wichita
Kansas
67205
United States
Heartland Research Associates, LLC
Wichita
Kansas
67207
United States
Kentucky Pediatric /Adult Research
Bardstown
Kentucky
40004
United States
University of Louisville
Louisville
Kentucky
40202
United States
Center for Pharmaceutical Research
Kansas City
Missouri
64114
United States
Radiant Research - St. Louis
St Louis
Missouri
63141
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
PMG Research of Raleigh, LLC
Cary
North Carolina
275188
United States
PMG Research of Raleigh, LLC
Raleigh
North Carolina
27609
United States
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
45229
United States
Primary Physicians Research
Pittsburgh
Pennsylvania
15205
United States
Primary Physicians Research
Upper Saint Clair
Pennsylvania
15241
United States
Omega Medical Research
Warwick
Rhode Island
02886
United States
Internal Medicine and Pediatrics Associates of Bristol, PC
Bristol
Tennessee
37520
United States
PMG Research of Bristoll, LLC
Bristol
Tennessee
37620
United States
J. Lewis Research Inc./Foothill Family Clinic South
Salt Lake City
Utah
84109
United States
J. Lewis Research Inc./Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
Advanced Clinical Research
West Jordan
Utah
84088
United States
J. Lewis Research/First Med
West Jordan
Utah
84088
United States
Group Health Research Institute
Seattle
Washington
98101
United States
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
FG002
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
FG003
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
FG004
13vPnC/13vPnC, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
FG005
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
FG006
23vPS/23vPS, Cohort 1
Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
FG007
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
FG000411 subjects
FG001411 subjects
FG002392 subjects
FG003854 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000411 subjects
FG001411 subjects
FG002392 subjects
FG003502 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003352 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Did not enter 1-year blood draw
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003352 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Vax 2/Year 3 to 4
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004108 subjects
FG005108 subjects
FG006189 subjects
FG007214 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Vax 1 Baseline/6-Month Follow-up
Type
Comment
Milestone Data
STARTED
FG000418 subjects
FG001417 subjects
FG002406 subjects
FG003900 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Vaccinated
FG000417 subjects
FG001414 subjects
FG002404 subjects
FG003899 subjects
FG004
COMPLETED
FG000411 subjects
FG001411 subjects
FG002392 subjects
FG003854 subjects
FG004
NOT COMPLETED
FG0007 subjects
FG0016 subjects
FG00214 subjects
FG00346 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG003
Vax 1/Year 1 Follow-up
Type
Comment
Milestone Data
STARTED
FG000411 subjects
FG001411 subjects
FG002392 subjects
FG003502 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000404 subjects
FG001396 subjects
FG002373 subjects
FG003469 subjects
FG004
NOT COMPLETED
FG0007 subjects
FG00115 subjects
FG00219 subjects
FG00333 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0015 subjects
FG0022 subjects
FG003
Between Year 1 - Vax 2/Year 3 to 4
Type
Comment
Milestone Data
STARTED
FG000404 subjects
FG001396 subjects
FG002373 subjects
FG003469 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000216 subjects
FG001189 subjects
FG002214 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG000188 subjects
FG001207 subjects
FG002159 subjects
FG003469 subjects
FG004
Type
Comment
Reasons
Did Not Consent to Receive Vax 2
FG000188 subjects
FG001207 subjects
FG002159 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
BG001
23vPS, Cohort 1
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
BG002
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
BG003
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000417
BG001414
BG002403
BG003899
BG0042133
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
In 13vPnc, Cohort 2; out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence baseline characteristics are available for 403 participant.
Number
participants
Title
Denominators
Categories
18 to 29 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
In 13vPnc, Cohort 2; out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence baseline characteristics are available for 403 participant.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000223
BG001
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
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 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 included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 2
ID
Title
Description
OG000
13vPnC/13vPnC, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
OG001
23vPS/23vPS, Cohort 1
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG002
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG003
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
Units
Counts
Participants
OG00080
OG001167
OG00289
OG003
Title
Denominators
Categories
Redness: Any
ParticipantsOG00050
ParticipantsOG001109
ParticipantsOG00251
ParticipantsOG003
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 2
ID
Title
Description
OG000
13vPnC/13vPnC, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
OG001
23vPS/23vPS, Cohort 1
Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG002
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Posted
Geometric Mean
95% Confidence Interval
titer
One month after vaccination 1
ID
Title
Description
OG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
OG002
Primary
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.
Posted
Number
95% Confidence Interval
percentage of participants
One month after vaccination 1
ID
Title
Description
OG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
Units
Counts
Participants
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Posted
Geometric Mean
95% Confidence Interval
titers
One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
ID
Title
Description
OG000
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
Secondary
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Posted
Number
95% Confidence Interval
Percentage of participants
One month after vaccination 1
ID
Title
Description
OG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
Secondary
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
ID
Title
Description
OG000
13vPnC/13vPnC, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
OG001
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG002
23vPS/23vPS, Cohort 1
Secondary
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
ID
Title
Description
OG000
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
OG002
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 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 [lim] 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 included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 1
ID
Title
Description
OG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 1
ID
Title
Description
OG000
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at Year 0.
OG001
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.
Time Frame
Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
Description
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic 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, Cohort 1
Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 [Vax1]), reported after vaccination.
1
417
277
417
EG001
13vPnC: 6 Month Follow-up After Vax 1, Cohort 1
Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
12
417
0
417
EG002
23vPS, Cohort 1
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
2
414
271
414
EG003
23vPS: 6 Month Follow-up After Vax 1, Cohort 1
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
10
414
5
414
EG004
13vPnC, Cohort 2
Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
2
403
293
403
EG005
13vPnC: 6 Month Follow-up After Vax 1, Cohort 2
Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
5
403
2
403
EG006
13vPnC/13vPnC, Cohort 1
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
1
108
66
108
EG007
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
2
108
1
108
EG008
13vPnC/23vPS, Cohort 1
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
1
108
73
108
EG009
13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
1
108
4
108
EG010
23vPS/23vPS, Cohort 1
Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
0
189
143
189
EG011
23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
3
189
13
189
EG012
13vPnC/13vPnC, Cohort 2
Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
0
214
164
214
EG013
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2
Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
0
214
4
214
EG014
13vPnC, Cohort 3
Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
2
899
779
899
EG015
13vPnC: 6 Month Follow-up After Vax 1, Cohort 3
Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
2
899
1
899
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0021 affected414 at risk
EG0030 affected414 at risk
EG0040 affected403 at risk
EG0050 affected403 at risk
EG0060 affected108 at risk
EG0070 affected108 at risk
EG0080 affected108 at risk
EG0090 affected108 at risk
EG0100 affected189 at risk
EG0110 affected189 at risk
EG0120 affected214 at risk
EG0130 affected214 at risk
EG0140 affected899 at risk
EG0150 affected899 at risk
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Endometrial cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Gastrooesophageal reflux
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Thrombosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0011 affected417 at risk
EG0020 affected414 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Lymphadenectomy
Surgical and medical procedures
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Ovarian cyst ruptured
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Redness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00039 affected193 at risk
EG0010 affected0 at risk
EG00227 affected190 at risk
EG0030 affected0 at risk
EG00424 affected152 at risk
EG0050 affected0 at risk
EG00610 affected50 at risk
EG0070 affected0 at risk
EG00814 affected51 at risk
EG0090 affected0 at risk
EG01039 affected109 at risk
EG0110 affected0 at risk
EG01218 affected84 at risk
EG0130 affected0 at risk
EG01481 affected266 at risk
EG0150 affected899 at risk
Redness (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00030 affected189 at risk
EG0010 affected0 at risk
EG00221 affected187 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00016 affected185 at risk
EG0010 affected0 at risk
EG0029 affected182 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0003 affected178 at risk
EG0010 affected0 at risk
EG0020 affected179 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00038 affected197 at risk
EG0010 affected0 at risk
EG00225 affected191 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00030 affected192 at risk
EG0010 affected0 at risk
EG00219 affected189 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00015 affected184 at risk
EG0010 affected0 at risk
EG0028 affected181 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected0 at risk
EG0022 affected180 at risk
EG003
Pain (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000265 affected331 at risk
EG0010 affected0 at risk
EG002221 affected301 at risk
EG003
Pain (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000254 affected323 at risk
EG0010 affected0 at risk
EG002199 affected290 at risk
EG003
Pain (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00048 affected206 at risk
EG0010 affected0 at risk
EG00263 affected210 at risk
EG003
Pain (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0003 affected178 at risk
EG0010 affected0 at risk
EG00216 affected187 at risk
EG003
Limitation of arm movement (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00061 affected214 at risk
EG0010 affected0 at risk
EG00265 affected211 at risk
EG003
Limitation of arm movement (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00057 affected212 at risk
EG0010 affected0 at risk
EG00261 affected208 at risk
EG003
Limitation of arm movement (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0004 affected179 at risk
EG0010 affected0 at risk
EG0027 affected182 at risk
EG003
Limitation of arm movement (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0003 affected180 at risk
EG0010 affected0 at risk
EG0028 affected185 at risk
EG003
Fatigue
General disorders
Systemic Events
Systematic Assessment
EG000175 affected277 at risk
EG0010 affected0 at risk
EG002168 affected273 at risk
EG003
Headache
General disorders
Systemic Events
Systematic Assessment
EG000136 affected252 at risk
EG0010 affected0 at risk
EG002141 affected259 at risk
EG003
Chills
General disorders
Systemic Events
Systematic Assessment
EG00048 affected204 at risk
EG0010 affected0 at risk
EG00248 affected199 at risk
EG003
Rash
General disorders
Systemic Events
Systematic Assessment
EG00032 affected194 at risk
EG0010 affected0 at risk
EG00225 affected192 at risk
EG003
Vomiting
General disorders
Systemic Events
Systematic Assessment
EG0007 affected180 at risk
EG0010 affected0 at risk
EG00210 affected186 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
EG00043 affected202 at risk
EG0010 affected0 at risk
EG00245 affected207 at risk
EG003
New generalized muscle pain
General disorders
Systemic Events
Systematic Assessment
EG000140 affected249 at risk
EG0010 affected0 at risk
EG002155 affected268 at risk
EG003
Aggravated generalized muscle pain
General disorders
Systemic Events
Systematic Assessment
EG00070 affected215 at risk
EG0010 affected0 at risk
EG00284 affected225 at risk
EG003
New generalized joint pain
General disorders
Systemic Events
Systematic Assessment
EG00048 affected197 at risk
EG0010 affected0 at risk
EG00265 affected216 at risk
EG003
Aggravated generalized joint pain
General disorders
Systemic Events
Systematic Assessment
EG00051 affected205 at risk
EG0010 affected0 at risk
EG00244 affected206 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Deafness bilateral
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Cataract
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Visual impairment
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Aphonia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Dementia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Atrophic vulvovaginitis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Venous insufficiency
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Eye irritation
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Eye pruritus
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Vision blurred
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0024 affected414 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Adverse drug reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Axillary pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Chills
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Influenza like illness
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site haematoma
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Injection site injury
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Injury associated with device
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Malaise
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Mass
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site pallor
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site rash
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0006 affected417 at risk
EG0010 affected417 at risk
EG0025 affected414 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected417 at risk
EG0010 affected417 at risk
EG0026 affected414 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0023 affected414 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Localised infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Gingival infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Fungal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hordeolum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Skin candida
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tinea infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0002 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Weight decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0005 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0002 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0002 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Sciatica
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Nipple exudate bloody
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected417 at risk
EG0010 affected417 at risk
EG0023 affected414 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Diaphragmalgia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0022 affected414 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Precancerous skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0021 affected414 at risk
EG003
Hot flush
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
hypotension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Fever Any (>=38 degrees C)
General disorders
Systemic Events
Systematic Assessment
EG00014 affected181 at risk
EG0010 affected0 at risk
EG00211 affected185 at risk
EG003
Fever Mild (>=38 degrees C but <38.5 degrees C)
General disorders
Systemic Events
Systematic Assessment
EG0007 affected179 at risk
EG0010 affected0 at risk
EG0022 affected180 at risk
EG003
Fever Moderate (>=38.5 degrees C but <39 degrees C)
General disorders
Systemic Events
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected0 at risk
EG0020 affected179 at risk
EG003
Fever Severe (>=39 degrees C but <=40 degrees C)
General disorders
Systemic Events
Systematic Assessment
EG0000 affected177 at risk
EG0010 affected0 at risk
EG0020 affected179 at risk
EG003
Fever Potentially life threatening (>40 degrees C)
General disorders
Systemic Events
Systematic Assessment
All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
EG0008 affected180 at risk
EG0010 affected0 at risk
EG0029 affected184 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site warmth
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site irritation
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Injection site induration
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Allergy to vaccine
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Heart rate increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Medial tibial stress syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Neuritis
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Tension headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Dermatitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected417 at risk
EG0010 affected417 at risk
EG0020 affected414 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG003
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
Units
Counts
Participants
OG00080
OG001162
OG00283
OG003167
Title
Denominators
Categories
Fever >=38 degrees C
ParticipantsOG00048
ParticipantsOG00179
ParticipantsOG00243
ParticipantsOG00375
Title
Measurements
OG0002.1(0.1 to 11.1)
OG0012.5(0.3 to 8.8)
OG0024.7(0.6 to 15.8)
OG003
Fever >= 38 to <38.5 degrees C
ParticipantsOG00047
ParticipantsOG00179
ParticipantsOG00242
ParticipantsOG00375
Fever >=38.5 to <39 degrees C
ParticipantsOG00048
ParticipantsOG00178
ParticipantsOG00242
ParticipantsOG00373
Fever >=39 to =<40 degrees C
ParticipantsOG00047
ParticipantsOG00178
ParticipantsOG00241
ParticipantsOG00373
Fever >40 degrees C
ParticipantsOG00047
ParticipantsOG00178
ParticipantsOG00241
ParticipantsOG00373
Fatigue
ParticipantsOG00069
ParticipantsOG001125
ParticipantsOG00268
ParticipantsOG003125
Headache
ParticipantsOG00060
ParticipantsOG001118
ParticipantsOG00264
ParticipantsOG003123
Chills
ParticipantsOG00052
ParticipantsOG00199
ParticipantsOG00256
ParticipantsOG00393
Rash
ParticipantsOG00051
ParticipantsOG00195
ParticipantsOG00249
ParticipantsOG00381
Vomiting
ParticipantsOG00048
ParticipantsOG00179
ParticipantsOG00243
ParticipantsOG00376
Decreased appetite
ParticipantsOG00052
ParticipantsOG00193
ParticipantsOG00254
ParticipantsOG00389
New generalized muscle pain
ParticipantsOG00060
ParticipantsOG001136
ParticipantsOG00266
ParticipantsOG003128
Aggravated generalized muscle pain
ParticipantsOG00051
ParticipantsOG001101
ParticipantsOG00258
ParticipantsOG00395
New generalized joint pain
ParticipantsOG00053
ParticipantsOG00191
ParticipantsOG00253
ParticipantsOG00393
Aggravated generalized joint pain
ParticipantsOG00051
ParticipantsOG00191
ParticipantsOG00249
ParticipantsOG00388
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).
OG003
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
Units
Counts
Participants
OG000411
OG001407
OG002388
OG003874
Title
Denominators
Categories
1
ParticipantsOG000404
ParticipantsOG001402
ParticipantsOG002382
ParticipantsOG003866
Title
Measurements
OG000146(124.0 to 172.9)
OG001104(87.7 to 124.4)
OG002200(170.3 to 236.0)
OG003
3
ParticipantsOG000394
ParticipantsOG001401
ParticipantsOG002379
ParticipantsOG003860
4
ParticipantsOG000359
ParticipantsOG001367
ParticipantsOG002350
ParticipantsOG003849
5
ParticipantsOG000392
ParticipantsOG001393
ParticipantsOG002373
ParticipantsOG003836
6A
ParticipantsOG000401
ParticipantsOG001392
ParticipantsOG002384
ParticipantsOG003855
6B
ParticipantsOG000371
ParticipantsOG001371
ParticipantsOG002361
ParticipantsOG003865
7F
ParticipantsOG000394
ParticipantsOG001396
ParticipantsOG002378
ParticipantsOG003859
9V
ParticipantsOG000367
ParticipantsOG001368
ParticipantsOG002364
ParticipantsOG003844
14
ParticipantsOG000375
ParticipantsOG001378
ParticipantsOG002373
ParticipantsOG003860
18C
ParticipantsOG000379
ParticipantsOG001381
ParticipantsOG002373
ParticipantsOG003850
19A
ParticipantsOG000392
ParticipantsOG001388
ParticipantsOG002377
ParticipantsOG003855
19F
ParticipantsOG000377
ParticipantsOG001370
ParticipantsOG002367
ParticipantsOG003841
23F
ParticipantsOG000375
ParticipantsOG001375
ParticipantsOG002368
ParticipantsOG003851
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: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.4
2-Sided
95
1.10
1.78
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.1
2-Sided
95
0.90
1.32
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.6
2-Sided
95
1.19
2.13
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.2
2-Sided
95
0.93
1.62
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
12.1
2-Sided
95
8.63
17.08
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
2.5
2-Sided
95
1.82
3.48
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
2.8
2-Sided
95
1.98
3.87
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
2.9
2-Sided
95
2.00
4.08
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
0.9
2-Sided
95
0.64
1.21
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.9
2-Sided
95
1.39
2.51
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.9
2-Sided
95
1.56
2.41
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
1.0
2-Sided
95
0.72
1.28
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
GMT Ratio
5.2
2-Sided
95
3.67
7.33
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.4
2-Sided
95
1.08
1.73
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.0
2-Sided
95
0.81
1.19
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.4
2-Sided
95
1.07
1.77
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.4
95
1.01
1.80
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.7
2-Sided
95
1.30
2.15
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.6
2-Sided
95
1.24
2.12
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.4
2-Sided
95
1.03
1.79
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.5
95
1.11
1.98
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.6
2-Sided
95
1.16
2.12
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.1
2-Sided
95
0.86
1.47
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.4
2-Sided
95
1.16
1.69
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.2
2-Sided
95
0.87
1.54
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.
GMT Ratio
1.3
2-Sided
95
0.94
1.84
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.4
2-Sided
95
2.03
2.87
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
1.0
2-Sided
95
0.84
1.13
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.3
2-Sided
95
1.92
2.76
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
1.9
2-Sided
95
1.55
2.42
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.2
2-Sided
95
1.84
2.67
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
4.9
2-Sided
95
4.13
5.93
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.9
2-Sided
95
2.41
3.49
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.9
2-Sided
95
2.34
3.52
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
4.9
2-Sided
95
4.01
5.93
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.3
2-Sided
95
1.91
2.79
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
2.3
2-Sided
95
2.02
2.66
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
3.0
2-Sided
95
2.44
3.60
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG003
Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.
GMT Ratio
4.2
2-Sided
95
3.31
5.31
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000374
OG001377
Title
Denominators
Categories
Title
Measurements
OG00088.5(84.8 to 91.6)
OG00149.3(44.2 to 54.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Percentage
39.2
2-Sided
95
33.0
45.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG002
23vPs/23vPS, Cohort 1
Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
Units
Counts
Participants
OG000108
OG001407
OG002189
Title
Denominators
Categories
1
ParticipantsOG000105
ParticipantsOG001184
ParticipantsOG002186
Title
Measurements
OG000398(306.2 to 516.3)
OG001116(89.4 to 149.6)
OG00295(74.8 to 121.1)
3
ParticipantsOG000107
ParticipantsOG001184
ParticipantsOG002181
Title
Measurements
OG000
4
ParticipantsOG000107
ParticipantsOG001174
ParticipantsOG002174
Title
Measurements
OG000
5
ParticipantsOG000106
ParticipantsOG001181
ParticipantsOG002180
Title
Measurements
OG000
6B
ParticipantsOG000104
ParticipantsOG001174
ParticipantsOG002181
Title
Measurements
OG000
7F
ParticipantsOG000105
ParticipantsOG001181
ParticipantsOG002182
Title
Measurements
OG000
9V
ParticipantsOG000107
ParticipantsOG001167
ParticipantsOG002177
Title
Measurements
OG000
14
ParticipantsOG000105
ParticipantsOG001173
ParticipantsOG002180
Title
Measurements
OG000
18C
ParticipantsOG000103
ParticipantsOG001174
ParticipantsOG002180
Title
Measurements
OG000
19A
ParticipantsOG000106
ParticipantsOG001182
ParticipantsOG002184
Title
Measurements
OG000
19F
ParticipantsOG00099
ParticipantsOG001170
ParticipantsOG002176
Title
Measurements
OG000
23F
ParticipantsOG000105
ParticipantsOG001173
ParticipantsOG002181
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: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
3.4
2-Sided
95
2.32
5.09
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
1.6
2-Sided
95
1.13
2.16
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
1.3
2-Sided
95
0.88
1.98
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
3.2
2-Sided
95
2.04
4.97
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
2.5
2-Sided
95
1.50
4.00
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
4.7
2-Sided
95
2.76
7.99
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
1.7
2-Sided
95
0.93
2.97
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
1.5
2-Sided
95
0.99
2.39
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
2.2
2-Sided
95
1.37
3.50
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
2.6
2-Sided
95
1.78
3.68
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
2.7
2-Sided
95
1.77
4.01
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMT Ratio
3.5
2-Sided
95
1.99
6.13
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
4.2
2-Sided
95
2.87
6.08
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
3.1
2-Sided
95
2.26
4.30
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT ratio
2.6
2-Sided
95
1.72
3.80
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
6.5
2-Sided
95
4.09
10.19
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
2.9
2-Sided
95
1.83
4.63
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
3.8
2-Sided
95
2.41
6.03
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
5.8
2-Sided
95
3.13
10.82
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
1.9
2-Sided
95
1.30
2.84
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
3.1
2-Sided
95
2.02
4.78
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
2.7
2-Sided
95
1.87
3.76
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
4.4
2-Sided
95
2.97
6.58
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMT Ratio
5.5
2-Sided
95
3.20
9.41
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG002
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
OG003
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
Units
Counts
Participants
OG000411
OG001407
OG002388
OG003874
Title
Denominators
Categories
1
ParticipantsOG000404
ParticipantsOG001402
ParticipantsOG002382
ParticipantsOG003866
Title
Measurements
OG00090.3(87.0 to 93.0)
OG00183.8(79.9 to 87.3)
OG00294.0(91.1 to 96.1)
OG003
3
ParticipantsOG000394
ParticipantsOG001401
ParticipantsOG002379
ParticipantsOG003860
4
ParticipantsOG000359
ParticipantsOG001367
ParticipantsOG002350
ParticipantsOG003849
5
ParticipantsOG000392
ParticipantsOG001393
ParticipantsOG002373
ParticipantsOG003836
6A
ParticipantsOG000401
ParticipantsOG001392
ParticipantsOG002384
ParticipantsOG003855
6B
ParticipantsOG000371
ParticipantsOG001371
ParticipantsOG002361
ParticipantsOG003865
7F
ParticipantsOG000394
ParticipantsOG001396
ParticipantsOG002378
ParticipantsOG003859
9V
ParticipantsOG000367
ParticipantsOG001368
ParticipantsOG002364
ParticipantsOG003844
14
ParticipantsOG000375
ParticipantsOG001378
ParticipantsOG002373
ParticipantsOG003860
18C
ParticipantsOG000379
ParticipantsOG001381
ParticipantsOG002373
ParticipantsOG003850
19A
ParticipantsOG000392
ParticipantsOG001388
ParticipantsOG002377
ParticipantsOG003855
19F
ParticipantsOG000377
ParticipantsOG001370
ParticipantsOG002367
ParticipantsOG003841
23F
ParticipantsOG000375
ParticipantsOG001375
ParticipantsOG002368
ParticipantsOG003851
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: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
6.5
2-Sided
95
1.9
11.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
3.9
2-Sided
95
-0.3
8.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
3.4
2-Sided
95
-0.2
7.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
2.3
2-Sided
95
-2.6
7.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
26.6
2-Sided
95
21.7
31.7
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
7.5
2-Sided
95
3.2
12.0
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
12.3
2-Sided
95
7.3
17.4
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
14.1
2-Sided
95
8.7
19.5
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
-0.9
2-Sided
95
-5.6
3.8
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
6.5
2-Sided
95
2.6
10.5
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
4.1
2-Sided
95
1.2
7.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG001
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
Difference in Percentage
-1.2
2-Sided
95
-5.5
3.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
23.2
2-Sided
95
17.0
29.3
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
3.6
2-Sided
95
-0.2
7.5
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
0.2
2-Sided
95
-3.6
4.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
2.4
2-Sided
95
-0.4
5.5
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
-0.9
2-Sided
95
-5.8
3.9
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
2.2
2-Sided
95
-0.4
4.8
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
4.0
2-Sided
95
0.8
7.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
4.4
2-Sided
95
0.6
8.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
3.8
2-Sided
95
-0.3
7.9
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Perecentage
4.2
2-Sided
95
-0.1
8.7
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
-0.6
2-Sided
95
-3.8
2.5
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
-0.1
2-Sided
95
-2.1
1.9
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
1.9
2-Sided
95
-2.4
6.2
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG002
Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
0.5
2-Sided
95
-4.7
5.7
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
7.2
2-Sided
95
4.3
10.6
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
2.6
2-Sided
95
-0.3
5.9
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
4.2
2-Sided
95
2.1
6.9
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
5.1
2-Sided
95
1.4
9.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
3.7
2-Sided
95
1.7
6.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
6.4
2-Sided
95
4.1
9.3
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
8.2
2-Sided
95
5.4
11.6
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
7.8
2-Sided
95
4.8
11.4
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
11.2
2-Sided
95
8.0
14.9
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
3.1
2-Sided
95
0.9
5.7
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
1.4
2-Sided
95
0.3
3.1
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
8.4
2-Sided
95
5.4
12.0
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
OG000
OG003
Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.
Difference in Percentage
10.5
2-Sided
95
6.8
14.7
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.
Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG003
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
Units
Counts
Participants
OG000108
OG001108
OG002189
OG003211
Title
Denominators
Categories
1
ParticipantsOG000102
ParticipantsOG001103
ParticipantsOG002185
ParticipantsOG003202
Title
Measurements
OG00072.6(53.90 to 97.82)
OG00169.7(51.85 to 93.79)
OG00215.6(12.38 to 19.73)
OG003
3
ParticipantsOG00098
ParticipantsOG001100
ParticipantsOG002176
ParticipantsOG003198
4
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG002136
ParticipantsOG003165
5
ParticipantsOG000101
ParticipantsOG001103
ParticipantsOG002177
ParticipantsOG003201
6A
ParticipantsOG00093
ParticipantsOG00199
ParticipantsOG002166
ParticipantsOG003189
6B
ParticipantsOG00089
ParticipantsOG00189
ParticipantsOG002157
ParticipantsOG003181
7F
ParticipantsOG00097
ParticipantsOG001100
ParticipantsOG002173
ParticipantsOG003193
9V
ParticipantsOG00085
ParticipantsOG00193
ParticipantsOG002147
ParticipantsOG003172
14
ParticipantsOG00095
ParticipantsOG00197
ParticipantsOG002165
ParticipantsOG003189
18C
ParticipantsOG00095
ParticipantsOG00197
ParticipantsOG002170
ParticipantsOG003191
19A
ParticipantsOG00096
ParticipantsOG00193
ParticipantsOG002168
ParticipantsOG003196
19F
ParticipantsOG00093
ParticipantsOG00193
ParticipantsOG002160
ParticipantsOG003186
23F
ParticipantsOG00095
ParticipantsOG00197
ParticipantsOG002169
ParticipantsOG003188
23vPs/23vPS, Cohort 1
Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
OG003
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
Units
Counts
Participants
OG000108
OG001407
OG002189
OG003211
Title
Denominators
Categories
1
ParticipantsOG00099
ParticipantsOG00148
ParticipantsOG00298
ParticipantsOG00398
Title
Measurements
OG0009.53(7.53 to 12.07)
OG0014.13(2.86 to 5.96)
OG0024.36(3.33 to 5.72)
OG003
3
ParticipantsOG00099
ParticipantsOG00146
ParticipantsOG00298
ParticipantsOG00398
4
ParticipantsOG00099
ParticipantsOG00148
ParticipantsOG00298
ParticipantsOG00393
5
ParticipantsOG00099
ParticipantsOG00147
ParticipantsOG00298
ParticipantsOG00397
6B
ParticipantsOG00098
ParticipantsOG00147
ParticipantsOG00298
ParticipantsOG00397
7F
ParticipantsOG00098
ParticipantsOG00147
ParticipantsOG00297
ParticipantsOG00395
9V
ParticipantsOG00099
ParticipantsOG00147
ParticipantsOG00297
ParticipantsOG00397
14
ParticipantsOG00097
ParticipantsOG00147
ParticipantsOG00298
ParticipantsOG00397
18C
ParticipantsOG00098
ParticipantsOG00148
ParticipantsOG00298
ParticipantsOG00398
19A
ParticipantsOG00098
ParticipantsOG00148
ParticipantsOG00298
ParticipantsOG00398
19F
ParticipantsOG00098
ParticipantsOG00146
ParticipantsOG00297
ParticipantsOG00396
23F
ParticipantsOG00098
ParticipantsOG00148
ParticipantsOG00297
ParticipantsOG00396
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: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
2.31
2-Sided
95
1.52
3.51
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.37
2-Sided
95
0.95
1.99
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
2.32
2-Sided
95
1.47
3.64
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.40
2-Sided
95
0.92
2.12
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.47
2-Sided
95
1.01
2.16
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.03
2-Sided
95
0.67
1.59
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.34
2-Sided
95
0.94
1.92
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.33
2-Sided
95
0.80
2.23
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.04
2-Sided
95
0.68
1.59
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.15
2-Sided
95
0.80
1.66
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.79
95
1.07
3.00
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG001
Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).
GMC Ratio
1.45
2-Sided
95
0.95
2.24
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
2.18
2-Sided
95
1.53
3.12
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.42
2-Sided
95
1.06
1.91
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
2.47
2-Sided
95
1.71
3.55
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.99
2-Sided
95
1.45
2.74
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
2.04
2-Sided
95
1.50
2.76
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.85
2-Sided
95
1.32
2.58
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.96
2-Sided
95
1.46
2.62
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.96
2-Sided
95
1.32
2.91
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.36
2-Sided
95
0.94
1.97
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
1.48
2-Sided
95
1.08
2.03
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
3.35
2-Sided
95
2.19
5.12
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG000
OG002
Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).
GMC Ratio
2.00
2-Sided
95
1.41
2.83
Non-Inferiority or Equivalence (legacy)
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG002
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).
OG003
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
Units
Counts
Participants
OG000337
OG001307
OG002327
OG003801
Title
Denominators
Categories
Redness: Any
ParticipantsOG000193
ParticipantsOG001190
ParticipantsOG002152
ParticipantsOG003266
Title
Measurements
OG00020.2(14.8 to 26.6)
OG00114.2(9.6 to 20.0)
OG00215.8(10.4 to 22.6)
OG003
Redness: Mild
ParticipantsOG000189
ParticipantsOG001187
ParticipantsOG002151
ParticipantsOG003258
Redness: Moderate
ParticipantsOG000185
ParticipantsOG001182
ParticipantsOG002140
ParticipantsOG003227
Redness: Severe
ParticipantsOG000178
ParticipantsOG001179
ParticipantsOG002137
ParticipantsOG003211
Swelling: Any
ParticipantsOG000197
ParticipantsOG001191
ParticipantsOG002161
ParticipantsOG003302
Swelling: Mild
ParticipantsOG000192
ParticipantsOG001189
ParticipantsOG002160
ParticipantsOG003293
Swelling: Moderate
ParticipantsOG000184
ParticipantsOG001181
ParticipantsOG002138
ParticipantsOG003238
Swelling: Severe
ParticipantsOG000178
ParticipantsOG001180
ParticipantsOG002136
ParticipantsOG003209
Pain: Any
ParticipantsOG000331
ParticipantsOG001301
ParticipantsOG002322
ParticipantsOG003787
Pain: Mild
ParticipantsOG000323
ParticipantsOG001290
ParticipantsOG002306
ParticipantsOG003721
Pain: Moderate
ParticipantsOG000206
ParticipantsOG001210
ParticipantsOG002190
ParticipantsOG003467
Pain: Severe
ParticipantsOG000178
ParticipantsOG001187
ParticipantsOG002139
ParticipantsOG003238
Lim of arm movement:Any
ParticipantsOG000214
ParticipantsOG001211
ParticipantsOG002194
ParticipantsOG003499
Lim of arm movement:Mild
ParticipantsOG000212
ParticipantsOG001208
ParticipantsOG002189
ParticipantsOG003466
Lim of arm movement:Moderate
ParticipantsOG000179
ParticipantsOG001182
ParticipantsOG002140
ParticipantsOG003238
Lim of arm movement:Severe
ParticipantsOG000180
ParticipantsOG001185
ParticipantsOG002139
ParticipantsOG003237
OG002
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.
OG003
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).