Study Evaluating a 13-valent Pneumococcal Conjugate Vacci... | NCT00500357 | Trialant
NCT00500357
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Apr 19, 2011Estimated
Enrollment
105Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal Conjugate Vaccine
Interventions
13-valent Pneumococcal Conjugate Vaccine
Countries
South Africa
Protocol Section
Identification Module
NCT ID
NCT00500357
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6115A1-3009
Secondary IDs
Not provided
Brief Title
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Official Title
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2007
Primary Completion Date
Jan 2010Actual
Completion Date
Jan 2010Actual
First Submitted Date
Jul 10, 2007
First Submission Date that Met QC Criteria
Jul 10, 2007
First Posted Date
Jul 12, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 21, 2011
Results First Submitted that Met QC Criteria
Jan 21, 2011
Results First Posted Date
Feb 17, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 21, 2009
Certification/Extension First Submitted that Passed QC Review
Sep 24, 2009
Certification/Extension First Posted Date
Sep 28, 2009Estimated
Last Update Submitted Date
Apr 15, 2011
Last Update Posted Date
Apr 19, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.
Detailed Description
Not provided
Conditions Module
Conditions
Vaccines, Pneumococcal Conjugate Vaccine
Keywords
Not provided
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
105Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
13-valent Pneumococcal Conjugate Vaccine
Biological
1 dose 13vPnC
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Secondary Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).
Eligibility Module
Eligibility Criteria
Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
Generally healthy male or female adults 65 years of age or older
Available for the duration of the trial - approximately 1 month
No history of severe adverse reaction associated with a vaccine
MMSE score less than or equal to 21 was an exclusion criteria.
Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
105 participants from the core study NCT00269672 (6115A1-500) who had received 13vPnC+AlPO4 (13vPnC) followed by 23vPS enrolled in the follow-up study NCT00500357 (6115A1-3009) 1 year after completion of the core study and received a subsequent 13vPnC dose at Year 2 (Vax 3).
Recruitment Details
915 participants were enrolled in core study NCT00269672 (6115A1-500); 914 participants received 13-valent pneumococcal conjugate vaccine plus or minus aluminum phosphate (13vPnC+AlPO4 or 13vPnC-AlPO4) or 23-valent pneumococcal polysaccharide vaccine (23vPS) in Year 0 (Vaccination 1 [Vax 1]) followed by 13vPnC+AlPO4 or 23vPS in Year 1 (Vax 2).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC (Vax 3 Follow-up / NCT00500357)
Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.
Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Bloemfontein
9317
South Africa
Brits
0250
South Africa
Cape Town
7941
South Africa
Cape Town
7945
South Africa
eManzimtoti
4126
South Africa
Lenasia
1827
South Africa
Paarl
7646
South Africa
Parow
7500
South Africa
Parys
9585
South Africa
Pretoria
0002
South Africa
Pretoria
0082
South Africa
Pretoria
0083
South Africa
Pretoria
0183
South Africa
Scottburgh South
4180
South Africa
Vanderbijlpark
1911
South Africa
FG000105 subjects
Received 13vPnC (Vax 3)
FG000105 subjects
Evaluable Immunogenicity Population
FG00098 subjectsAdministered Vax 1 and Vax 2 in study 6115A1-500; Vax 3 and at least 1 assay result in 6115A1-3009.
COMPLETED
FG000104 subjects
NOT COMPLETED
FG0001 subjects
Type
Comment
Reasons
Death
FG0001 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC (Vax 3 Follow-up / NCT00500357)
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Denominators
Units
Counts
Participants
BG000105
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00072.8± 4.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00056
Male
BG00049
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
ID
Title
Description
OG000
13vPnC (Vax 1 Core Study/NCT00269672)
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Units
Counts
Participants
OG00096
OG00196
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000198(133.7 to 293.0)
OG00178(55.4 to 108.8)
Serotype 3
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.4
2-Sided
95
0.28
0.56
Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus [-] Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).
Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.
Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Units
Counts
Participants
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
ID
Title
Description
OG000
13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean concentration (mcg/mL)
Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
ID
Title
Description
OG000
13vPnC (Vax 1 Core Study/NCT00269672)
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean concentration (mcg/mL)
Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
ID
Title
Description
OG000
13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Time Frame
Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
Description
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
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 / 23vPS / 13vPnC (Vax 3 Follow-up Study)
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46.
2
105
46
105
EG001
13vPnC+AlPO4 (After Vax 1 Core Study)
Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
2
308
70
308
EG002
13vPnC-AlPO4 (After Vax 1 Core Study)
Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
4
304
58
304
EG003
23vPS (After Vax 1 Core Study)
Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
3
139
26
139
EG005
13vPnC+AlPO4/23vPS (After Vax 2 Core Study)
Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1
128
35
128
EG006
13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1
273
76
273
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardio-respiratory arrest
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG0030 affected0 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG0030 affected0 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Drug hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Viral rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected105 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0006 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0005 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00014 affected83 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00010 affected81 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0007 affected81 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Pain (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00036 affected89 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Pain (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00030 affected88 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Pain (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00013 affected83 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Pain (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0009 affected80 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0007 affected80 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Fever (any) ≥ 38 degrees Celsius (C)
General disorders
Systemic events
Systematic Assessment
EG0006 affected81 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Fever (mild) ≥ 38 but <38.5 degrees C
General disorders
Systemic events
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Fever (moderate) ≥ 38.5 but <39 degrees C
General disorders
Systemic events
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Fever (severe) ≥ 39 but ≤40 degrees C
General disorders
Systemic events
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Fever (potentially life-threatening) >40 degrees C
General disorders
Systemic events
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Fatigue
General disorders
Systemic events
Systematic Assessment
EG00023 affected83 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Headache
General disorders
Systemic events
Systematic Assessment
EG00016 affected81 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Chills
General disorders
Systemic events
Systematic Assessment
EG0007 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Rash
General disorders
Systemic events
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Vomiting
General disorders
Systemic events
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Decreased appetitie
General disorders
Systemic events
Systematic Assessment
EG00015 affected82 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
New muscle pain
General disorders
Systemic events
Systematic Assessment
EG00018 affected84 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Aggravated muscle pain
General disorders
Systemic events
Systematic Assessment
EG00010 affected80 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
New joint pain
General disorders
Systemic events
Systematic Assessment
EG0006 affected78 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Aggravated joint pain
General disorders
Systemic events
Systematic Assessment
EG0005 affected79 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Dacryoadenitis acquired
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Eye pain
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Anal polyp
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0019 affected308 at risk
EG00217 affected304 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0016 affected308 at risk
EG0029 affected304 at risk
EG003
Injection site movement impairment
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0016 affected308 at risk
EG0026 affected304 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0019 affected308 at risk
EG0023 affected304 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0016 affected308 at risk
EG0024 affected304 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0022 affected304 at risk
EG003
Chills
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Injection site inflammation
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Injection site joint movement impairment
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Malaise
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Asthenia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Injection site induration
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Injection site rash
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0012 affected308 at risk
EG0023 affected304 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0013 affected308 at risk
EG0020 affected304 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0022 affected304 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0012 affected308 at risk
EG0020 affected304 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Tinea infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Parotitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Viral rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Body temperature increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0016 affected308 at risk
EG0025 affected304 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0018 affected308 at risk
EG0027 affected304 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0016 affected308 at risk
EG0027 affected304 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0012 affected308 at risk
EG0020 affected304 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0021 affected304 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0022 affected304 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG00111 affected308 at risk
EG00217 affected304 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0022 affected304 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Lentigo
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0021 affected304 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0011 affected308 at risk
EG0020 affected304 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected308 at risk
EG0020 affected304 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.govCallCenter@pfizer.com
126
(94.2 to 167.8)
OG001104(81.5 to 132.5)
Serotype 4
Title
Measurements
OG0002210(1603.5 to 3045.2)
OG0011254(926.6 to 1695.7)
Serotype 5
Title
Measurements
OG000413(278.0 to 614.9)
OG001170(119.7 to 241.3)
Serotype 6A
Title
Measurements
OG0004931(3391.0 to 7170.8)
OG0013158(2369.3 to 4209.7)
Serotype 6B
Title
Measurements
OG0003251(2105.0 to 5019.6)
OG0012440(1753.2 to 3395.1)
Serotype 7F
Title
Measurements
OG000869(540.3 to 1398.0)
OG001353(221.7 to 561.0)
Serotype 9V
Title
Measurements
OG000977(588.6 to 1620.4)
OG001247(142.9 to 426.8)
Serotype 14
Title
Measurements
OG000982(676.0 to 1425.8)
OG001550(392.5 to 769.8)
Serotype 18C
Title
Measurements
OG0002860(1899.9 to 4304.6)
OG0011457(1057.8 to 2008.1)
Serotype 19A
Title
Measurements
OG0001141(832.4 to 1564.3)
OG001431(340.3 to 546.1)
Serotype 19F
Title
Measurements
OG0001014(654.4 to 1572.6)
OG001494(341.4 to 715.5)
Serotype 23F
Title
Measurements
OG000523(315.4 to 867.7)
OG001661(443.6 to 985.8)
OG000
OG001
Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.67
1.01
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.6
2-Sided
95
0.44
0.72
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.4
2-Sided
95
0.32
0.53
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.6
2-Sided
95
0.45
0.91
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.56
1.01
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.4
2-Sided
95
0.25
0.65
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.3
2-Sided
95
0.16
0.40
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.6
2-Sided
95
0.40
0.78
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.5
2-Sided
95
0.40
0.65
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.4
2-Sided
95
0.30
0.48
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.5
2-Sided
95
0.35
0.67
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
1.3
2-Sided
95
0.86
1.86
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
Units
Counts
Participants
OG00091
Title
Denominators
Categories
Redness: Any (n=79)
Title
Measurements
OG0007.6
Redness: Mild (n=79)
Title
Measurements
OG0006.3
Redness: Moderate (n=78)
Title
Measurements
OG0003.8
Redness: Severe (n=78)
Title
Measurements
OG0000.0
Swelling: Any (n=83)
Title
Measurements
OG00016.9
Swelling: Mild (n=81)
Title
Measurements
OG00012.3
Swelling: Moderate (n=81)
Title
Measurements
OG0008.6
Swelling: Severe (n=78)
Title
Measurements
OG0000.0
Pain: Any (n=89)
Title
Measurements
OG00040.4
Pain: Mild (n=88)
Title
Measurements
OG00034.1
Pain: Moderate (n=83)
Title
Measurements
OG00015.7
Pain: Severe (n=78)
Title
Measurements
OG0000.0
Limitation of arm movement: Any (n=80)
Title
Measurements
OG00011.3
Limitation of arm movement: Mild (n=80)
Title
Measurements
OG0008.8
Limitation of arm movement: Moderate (n=78)
Title
Measurements
OG0002.6
Limitation of arm movement: Severe (n=79)
Title
Measurements
OG0001.3
OG00091
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=81)
Title
Measurements
OG0007.4
Fever: Mild ≥38 but <38.5 degrees C (n=80)
Title
Measurements
OG0003.8
Fever: Moderate ≥38.5 but <39 degrees C (n=78)
Title
Measurements
OG0002.6
Fever: Severe ≥39 but ≤40 degrees C (n=80)
Title
Measurements
OG0002.5
Potentially life-threatening >40 degrees C (n=79)
Title
Measurements
OG0001.3
Fatigue (n=83)
Title
Measurements
OG00027.7
Headache (n=81)
Title
Measurements
OG00019.8
Chills (n=79)
Title
Measurements
OG0008.9
Rash (n=78)
Title
Measurements
OG0002.6
Vomiting (n=79)
Title
Measurements
OG0001.3
Decreased appetite (n=82)
Title
Measurements
OG00018.3
New muscle pain (n=84)
Title
Measurements
OG00021.4
Aggravated muscle pain (n=80)
Title
Measurements
OG00012.5
New joint pain (n=78)
Title
Measurements
OG0007.7
Aggravated joint pain (n=79)
Title
Measurements
OG0006.3
Units
Counts
Participants
OG00097
OG00197
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000184(136.2 to 249.2)
OG00181(58.3 to 112.5)
Serotype 3
Title
Measurements
OG000131(102.2 to 168.9)
OG001104(81.5 to 132.5)
Serotype 4
Title
Measurements
OG0001457(1092.8 to 1942.2)
OG0011406(1098.1 to 1799.8)
Serotype 5
Title
Measurements
OG000326(228.4 to 464.0)
OG001219(153.6 to 312.8)
Serotype 6A
Title
Measurements
OG0001732(1163.1 to 2580.0)
OG0013443(2678.7 to 4425.1)
Serotype 6B
Title
Measurements
OG0001862(1333.5 to 2600.7)
OG0012505(1798.8 to 3488.1)
Serotype 7F
Title
Measurements
OG0001292(925.2 to 1803.5)
OG001351(224.5 to 550.1)
Serotype 9V
Title
Measurements
OG000624(371.0 to 1051.1)
OG001267(153.9 to 463.0)
Serotype 14
Title
Measurements
OG000808(599.4 to 1089.7)
OG001557(399.0 to 778.9)
Serotype 18C
Title
Measurements
OG0001753(1214.9 to 2528.5)
OG0011452(1049.6 to 2009.0)
Serotype 19A
Title
Measurements
OG000756(581.2 to 983.9)
OG001511(408.5 to 639.1)
Serotype 19F
Title
Measurements
OG000901(689.1 to 1177.3)
OG001527(369.1 to 752.7)
Serotype 23F
Title
Measurements
OG000484(323.7 to 723.6)
OG001731(499.0 to 1071.9)
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: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.4
2-Sided
95
0.34
0.57
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.66
0.95
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
1.0
2-Sided
95
0.76
1.22
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.7
2-Sided
95
0.57
0.80
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
2.0
2-Sided
95
1.39
2.84
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
1.3
2-Sided
95
1.11
1.63
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.3
2-Sided
95
0.18
0.41
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.4
2-Sided
95
0.27
0.68
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.7
2-Sided
95
0.57
0.83
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.66
1.03
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.7
2-Sided
95
0.58
0.78
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.6
2-Sided
95
0.47
0.73
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
OG000
OG001
Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
1.5
2-Sided
95
1.18
1.94
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).
Units
Counts
Participants
OG00098
OG00198
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG0007.67(5.48 to 10.72)
OG0014.99(4.06 to 6.14)
Serotype 3
Title
Measurements
OG0002.60(2.04 to 3.33)
OG0011.35(1.12 to 1.62)
Serotype 4
Title
Measurements
OG0004.68(3.40 to 6.43)
OG0012.96(2.30 to 3.81)
Serotype 5
Title
Measurements
OG00019.51(13.92 to 27.36)
OG0016.33(5.08 to 7.90)
Serotype 6A
Title
Measurements
OG0009.12(6.70 to 12.42)
OG0018.22(6.30 to 10.72)
Serotype 6B
Title
Measurements
OG00013.03(9.11 to 18.62)
OG00110.32(8.10 to 13.14)
Serotype 7F
Title
Measurements
OG0006.93(5.45 to 8.81)
OG0015.02(4.23 to 5.95)
Serotype 9V
Title
Measurements
OG00011.56(8.68 to 15.40)
OG0015.77(4.70 to 7.09)
Serotype 14
Title
Measurements
OG00017.51(12.70 to 24.13)
OG00113.34(10.67 to 16.69)
Serotype 18C
Title
Measurements
OG00020.59(15.35 to 27.62)
OG0017.82(6.39 to 9.56)
Serotype 19A
Title
Measurements
OG00029.52(22.14 to 39.36)
OG00117.80(14.67 to 21.60)
Serotype 19F
Title
Measurements
OG00013.39(9.47 to 18.92)
OG0018.55(6.60 to 11.07)
Serotype 23F
Title
Measurements
OG00010.16(7.06 to 14.64)
OG0017.73(5.77 to 10.36)
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: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.65
2-Sided
95
0.52
0.82
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.52
2-Sided
95
0.43
0.62
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.63
2-Sided
95
0.53
0.76
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.32
2-Sided
95
0.27
0.39
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.90
2-Sided
95
0.74
1.10
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.79
2-Sided
95
0.63
0.99
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.72
2-Sided
95
0.60
0.87
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.50
2-Sided
95
0.42
0.60
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.76
2-Sided
95
0.59
0.98
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.38
2-Sided
95
0.31
0.46
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.60
2-Sided
95
0.49
0.74
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.64
2-Sided
95
0.52
0.79
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
OG000
OG001
Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
geometric mean fold rise
0.76
2-Sided
95
0.62
0.93
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).
No
Superiority or Other
Units
Counts
Participants
OG00098
OG00198
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG0007.29(5.96 to 8.93)
OG0014.99(4.06 to 6.14)
Serotype 3
Title
Measurements
OG0002.46(2.01 to 3.01)
OG0011.36(1.13 to 1.64)
Serotype 4
Title
Measurements
OG0003.93(3.03 to 5.11)
OG0012.96(2.30 to 3.81)
Serotype 5
Title
Measurements
OG0009.29(7.37 to 11.71)
OG0016.33(5.08 to 7.90)
Serotype 6A
Title
Measurements
OG0005.51(4.25 to 7.15)
OG0018.22(6.30 to 10.72)
Serotype 6B
Title
Measurements
OG0009.67(7.47 to 12.53)
OG00110.32(8.10 to 13.14)
Serotype 7F
Title
Measurements
OG0007.41(6.07 to 9.04)
OG0015.02(4.23 to 5.95)
Serotype 9V
Title
Measurements
OG0009.60(7.68 to 12.00)
OG0015.77(4.70 to 7.09)
Serotype 14
Title
Measurements
OG00022.67(17.89 to 28.72)
OG00113.34(10.67 to 16.69)
Serotype 18C
Title
Measurements
OG00011.66(9.66 to 14.07)
OG0017.82(6.39 to 9.56)
Serotype 19A
Title
Measurements
OG00022.78(18.47 to 28.11)
OG00117.80(14.67 to 21.60)
Serotype 19F
Title
Measurements
OG00015.82(11.97 to 20.91)
OG0018.55(6.60 to 11.07)
Serotype 23F
Title
Measurements
OG0007.27(5.52 to 9.57)
OG0017.73(5.77 to 10.36)
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: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.68
2-Sided
95
0.60
0.78
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.55
2-Sided
95
0.48
0.64
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.75
2-Sided
95
0.65
0.87
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.68
2-Sided
95
0.61
0.76
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
1.49
2-Sided
95
1.27
1.75
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
1.07
2-Sided
95
0.94
1.21
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.68
2-Sided
95
0.58
0.79
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.60
2-Sided
95
0.53
0.68
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.59
2-Sided
95
0.51
0.67
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.67
2-Sided
95
0.60
0.74
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.78
2-Sided
95
0.69
0.88
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
0.54
2-Sided
95
0.47
0.62
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).
No
Superiority or Other
OG000
OG001
Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
geometric mean fold rise
1.06
2-Sided
95
0.90
1.25
CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).