Study Evaluating 13-valent Pneumococcal Conjugate Vaccine... | NCT00761631 | Trialant
NCT00761631
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jul 31, 2013Estimated
Enrollment
1,200Actual
Phase
Phase 3
Conditions
Healthy Subjects
Interventions
13 valent pneumococcal conjugate vaccine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00761631
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-3011
Secondary IDs
Not provided
Brief Title
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Official Title
A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
May 2013
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
Dec 2008
Primary Completion Date
Jul 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Sep 25, 2008
First Submission Date that Met QC Criteria
Sep 26, 2008
First Posted Date
Sep 29, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 15, 2011
Results First Submitted that Met QC Criteria
Jul 15, 2011
Results First Posted Date
Aug 10, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 30, 2013
Last Update Posted Date
Jul 31, 2013Estimated
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 open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Single
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
28 to 42 days after dose 1 for Group 3
Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)
Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.
28 to 42 days after dose 1
Secondary Outcomes
Not provided
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects >15months to <18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).
Group 4 only:
Negative urine pregnancy test for female subjects who are menstruating.
Exclusion Criteria:
Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.
Group 4 only:
Previous vaccination with Prevnar or any other pneumococcal vaccine.
Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.
Participants were stratified by age group. Group 1 included participants aged greater than (>) 15 months to less than (<) 2 years. Group 2 included participants aged greater than or equal to (>=) 2 to <5 years. Group 3 included participants aged >=5 to <10 years. Group 4 included participants aged >=10 to <18 years.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC Group 1 (Cohort 1)
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
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
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.
28 to 42 days after dose 1 for Group 3 and 4
From the day of dose 1 (Day 1) to Day 7 after dose 1
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
From the day of dose 2 (Day 1) to Day 7 of dose 2
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.
From the day of dose 1 (Day 1) to Day 7 of dose 1
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.
From the day of dose 2 (Day 1) to Day 7 of dose 2
Fayetteville
Arkansas
72703
United States
Pfizer Investigational Site
Jonesboro
Arkansas
72401
United States
Pfizer Investigational Site
Little Rock
Arkansas
72205
United States
Pfizer Investigational Site
Fountain Valley
California
92708
United States
Pfizer Investigational Site
Loma Linda
California
92354
United States
Pfizer Investigational Site
Torrance
California
90502
United States
Pfizer Investigational Site
Tampa
Florida
33606
United States
Pfizer Investigational Site
Marietta
Georgia
30062
United States
Pfizer Investigational Site
DeKalb
Illinois
60115
United States
Pfizer Investigational Site
Louisville
Kentucky
40202-3830
United States
Pfizer Investigational Site
Saint Paul
Minnesota
55108
United States
Pfizer Investigational Site
Lebanon
New Hampshire
03756
United States
Pfizer Investigational Site
Whitehouse Station
New Jersey
08809
United States
Pfizer Investigational Site
Rochester
New York
14618
United States
Pfizer Investigational Site
Cary
North Carolina
27518
United States
Pfizer Investigational Site
Bismarck
North Dakota
58501
United States
Pfizer Investigational Site
Fargo
North Dakota
58103
United States
Pfizer Investigational Site
Cincinnati
Ohio
45229
United States
Pfizer Investigational Site
Cleveland
Ohio
44121
United States
Pfizer Investigational Site
Tulsa
Oklahoma
74127
United States
Pfizer Investigational Site
Philadelphia
Pennsylvania
19107
United States
Pfizer Investigational Site
Clarksville
Tennessee
37043
United States
Pfizer Investigational Site
Galveston
Texas
77555-0351
United States
Pfizer Investigational Site
San Antonio
Texas
78229
United States
Pfizer Investigational Site
Murray
Utah
84107
United States
Pfizer Investigational Site
Salt Lake City
Utah
84132
United States
Pfizer Investigational Site
South Jordan
Utah
84095
United States
Pfizer Investigational Site
Vienna
Virginia
22180
United States
Pfizer Investigational Site
Vancouver
Washington
98664
United States
Pfizer Investigational Site
Monroe
Wisconsin
53566
United States
Derived
Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.
FG001
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
FG002
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
FG003
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
FG004
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
FG005
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
FG000126 subjects
FG001181 subjects
FG002176 subjects
FG003119 subjects
FG004299 subjects
FG005299 subjects
Vaccinated Dose 1
FG000124 subjects
FG001179 subjects
FG002175 subjects
FG003118 subjects
FG004294 subjects
FG005298 subjects
Vaccinated Dose 2
FG000112 subjects
FG0010 subjects
FG002165 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000111 subjects
FG001174 subjects
FG002160 subjects
FG003116 subjects
FG004277 subjects
FG005294 subjects
NOT COMPLETED
FG00015 subjects
FG0017 subjects
FG00216 subjects
FG0033 subjects
FG00422 subjects
FG0055 subjects
Type
Comment
Reasons
Parent/legal guardian request
FG0008 subjects
FG0013 subjects
FG0028 subjects
FG0030 subjects
FG0045 subjects
FG0050 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0027 subjects
FG0031 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Randomized, not treated
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Failed to return
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC Group 1 (Cohort 1 and 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
BG001
13vPnC Group 2 (Cohort 1 and 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
BG002
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
BG003
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000302
BG001300
BG002299
BG003299
BG0041200
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
>15 months to <2 years
Title
Measurements
BG000302
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000148
BG001139
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
ID
Title
Description
OG000
13vPnC Group 1 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
OG001
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
Units
Counts
Participants
OG000109
OG001175
Title
Denominators
Categories
Common serotypes - serotype 4
Title
Measurements
OG00098.2(93.5 to 99.8)
OG001100.0(97.9 to 100.0)
Common serotypes - serotype 6B
Title
Measurements
OG000
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
28 to 42 days after dose 1 for Group 3
ID
Title
Description
OG000
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
Units
Counts
Participants
Primary
Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)
Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.
Not Posted
Geometric Mean
95% Confidence Interval
mcg/mL
28 to 42 days after dose 1
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.
EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.
Posted
Geometric Mean
95% Confidence Interval
titer
28 to 42 days after dose 1 for Group 3 and 4
ID
Title
Description
OG000
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
OG001
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
Other Pre-specified
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Dose 1 Safety Population: all participants who received the first dose of 13vPnC. '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
Percentage of participants
From the day of dose 1 (Day 1) to Day 7 after dose 1
ID
Title
Description
OG000
13vPnC Group 1 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
OG001
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
Other Pre-specified
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. '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
Percentage of participants
From the day of dose 2 (Day 1) to Day 7 of dose 2
ID
Title
Description
OG000
13vPnC Group 1 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
OG001
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
Other Pre-specified
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.
Dose 1 Safety Population: all participants who received the first dose of 13vPnC. '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
Percentage of participants
From the day of dose 1 (Day 1) to Day 7 of dose 1
ID
Title
Description
OG000
13vPnC Group 1 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
OG001
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
OG002
Other Pre-specified
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.
Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. '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
Percentage of participants
From the day of dose 2 (Day 1) to Day 7 of dose 2
ID
Title
Description
OG000
13vPnC Group 1 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
OG001
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
Time Frame
Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
Description
SAEs and AEs were grouped by system organ class and summarized. AEs included 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 Group 1 (Cohort 1) Dose 1
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
0
124
112
124
EG001
13vPnC Group 1 (Cohort 1) Dose 2
13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
2
112
91
112
EG002
13vPnC Group 2 (Cohort 1) Dose 1
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1
179
158
179
EG003
13vPnC Group 1 (Cohort 2) Dose 1
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1
175
165
175
EG004
13vPnC Group 1 (Cohort 2) Dose 2
13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
4
165
137
165
EG005
13vPnC Group 2 (Cohort 2) Dose 1
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
0
118
107
118
EG006
6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)
6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
3
299
2
299
EG007
6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)
6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
1
297
2
297
EG008
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1
294
242
294
EG009
6-Month Follow-up 13vPnC Group 3
6-month follow-up telephone contact for participants in Group 3.
0
294
7
294
EG010
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
0
298
258
298
EG011
6-Month Follow-up 13vPnC Group 4
6 -Month Follow-up Telephone Contact for participants in Group 4.
1
298
4
298
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG0030 affected175 at risk
EG0040 affected165 at risk
EG0050 affected118 at risk
EG0060 affected299 at risk
EG0070 affected297 at risk
EG0080 affected294 at risk
EG0090 affected294 at risk
EG0100 affected298 at risk
EG0110 affected298 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Near drowning
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Status asthmaticus
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG0033 affected175 at risk
EG0041 affected165 at risk
EG0050 affected118 at risk
EG0060 affected299 at risk
EG0070 affected297 at risk
EG0081 affected294 at risk
EG0090 affected294 at risk
EG0100 affected298 at risk
EG0110 affected298 at risk
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0014 affected112 at risk
EG0022 affected179 at risk
EG003
Hypermetropia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Eye swelling
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0006 affected124 at risk
EG0011 affected112 at risk
EG0024 affected179 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0007 affected124 at risk
EG0011 affected112 at risk
EG0021 affected179 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0021 affected179 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Tongue coated
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Duodenogastric reflux
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0005 affected124 at risk
EG0013 affected112 at risk
EG0023 affected179 at risk
EG003
Influenza like illness
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Injection site reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG00015 affected124 at risk
EG0015 affected112 at risk
EG00212 affected179 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0009 affected124 at risk
EG0019 affected112 at risk
EG0023 affected179 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected124 at risk
EG0011 affected112 at risk
EG0021 affected179 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected124 at risk
EG0013 affected112 at risk
EG0024 affected179 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected124 at risk
EG0010 affected112 at risk
EG0022 affected179 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0011 affected112 at risk
EG0025 affected179 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0011 affected112 at risk
EG0022 affected179 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0010 affected112 at risk
EG0022 affected179 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0011 affected112 at risk
EG0023 affected179 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0011 affected112 at risk
EG0021 affected179 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Eye infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Impetigo
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Lice infestation
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Paronychia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Intertrigo candida
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Otitis externa
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Urethritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Viral rash
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Cellulitis streptococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Coxsackie viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Erythema infectiosum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Folliculitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Traumatic brain injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Lactose intolerance
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Speech disorder developmental
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Breath holding
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Asperger's disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Attention deficit/hyperactivity disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Penile adhesion
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected124 at risk
EG0010 affected112 at risk
EG0027 affected179 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected124 at risk
EG0012 affected112 at risk
EG0024 affected179 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0011 affected112 at risk
EG0021 affected179 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0024 affected179 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0021 affected179 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0011 affected112 at risk
EG0020 affected179 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0012 affected112 at risk
EG0022 affected179 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0012 affected112 at risk
EG0020 affected179 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00055 affected108 at risk
EG00150 affected87 at risk
EG00296 affected155 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0007 affected92 at risk
EG0016 affected68 at risk
EG00215 affected141 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00025 affected97 at risk
EG00117 affected73 at risk
EG00232 affected144 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00020 affected94 at risk
EG00116 affected72 at risk
EG00229 affected143 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0009 affected94 at risk
EG0012 affected69 at risk
EG0028 affected141 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected90 at risk
EG0010 affected68 at risk
EG0020 affected138 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00041 affected103 at risk
EG00127 affected76 at risk
EG00252 affected149 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00031 affected99 at risk
EG00125 affected74 at risk
EG00246 affected146 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG00012 affected94 at risk
EG0015 affected70 at risk
EG00214 affected142 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected90 at risk
EG0010 affected68 at risk
EG0020 affected138 at risk
EG003
Fever >=38 degreesC but <=39 degreesC
General disorders
Systemic Events
Systematic Assessment
EG00015 affected92 at risk
EG00110 affected70 at risk
EG0027 affected138 at risk
EG003
Fever >39 degreesC but <=40 degreesC
General disorders
Systemic Events
Systematic Assessment
EG0004 affected90 at risk
EG0013 affected68 at risk
EG0021 affected138 at risk
EG003
Fever >40 degreesC
General disorders
Systemic Events
Systematic Assessment
EG0000 affected90 at risk
EG0010 affected68 at risk
EG0021 affected138 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
EG00042 affected99 at risk
EG00131 affected77 at risk
EG00237 affected149 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
EG00065 affected108 at risk
EG00156 affected86 at risk
EG00260 affected151 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
EG00032 affected98 at risk
EG00122 affected75 at risk
EG00223 affected145 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
EG00022 affected97 at risk
EG00122 affected77 at risk
EG00220 affected143 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
EG0001 affected90 at risk
EG0012 affected68 at risk
EG0021 affected139 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Dermatophytosis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Presyncope
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Myopia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Uvulitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Chills
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Furuncle
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Heart rate decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Acanthosis nigricans
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected124 at risk
EG0010 affected112 at risk
EG0020 affected179 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
6 subjects
FG0051 subjects
5 subjects
FG0051 subjects
0 subjects
FG0050 subjects
5 subjects
FG0052 subjects
0 subjects
FG0050 subjects
1 subjects
FG0051 subjects
0
BG004302
>=2 years to <5 years
Title
Measurements
BG0000
BG001300
BG0020
BG0030
BG004300
>=5 years to <10 years
Title
Measurements
BG0000
BG0010
BG002299
BG0030
BG004299
>10 years to <18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003299
BG004299
155
BG003136
BG004578
Male
BG000154
BG001161
BG002144
BG003163
BG004622
100.0
(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Common serotypes - serotype 9V
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Common serotypes - serotype 14
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Common serotypes - serotype 18C
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Common serotypes - serotype 19F
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Common serotypes - serotype 23F
Title
Measurements
OG00099.1(95.0 to 100.0)
OG001100.0(97.9 to 100.0)
Additional serotypes - serotype 1
Title
Measurements
OG000100.0(96.7 to 100.0)
OG00198.9(95.9 to 99.9)
Additional serotypes - serotype 3
Title
Measurements
OG00094.5(88.4 to 98.0)
OG00192.0(86.9 to 95.5)
Additional serotypes - serotype 5
Title
Measurements
OG000100.0(96.7 to 100.0)
OG00198.9(95.9 to 99.9)
Additional serotypes - serotype 6A
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Additional serotypes - serotype 7F
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
Additional serotypes - serotype 19A
Title
Measurements
OG000100.0(96.7 to 100.0)
OG001100.0(97.9 to 100.0)
OG000
171
Title
Denominators
Categories
Common serotypes - serotype 4
Title
Measurements
OG0008.45(7.24 to 9.87)
Common serotypes - serotype 6B
Title
Measurements
OG00053.56(45.48 to 63.07)
Common serotypes - serotype 9V
Title
Measurements
OG0009.51(8.38 to 10.78)
Common serotypes - serotype 14
Title
Measurements
OG00029.36(24.78 to 34.78)
Common serotypes - serotype 18C
Title
Measurements
OG0008.23(7.13 to 9.51)
Common serotypes - serotype 19F
Title
Measurements
OG00017.58(14.95 to 20.67)
Common serotypes - serotype 23F
Title
Measurements
OG00011.26(9.79 to 12.95)
Additional serotypes - serotype 1
Title
Measurements
OG0003.57(3.05 to 4.18)
Additional serotypes - serotype 3
Title
Measurements
OG0002.38(2.07 to 2.74)
Additional serotypes - serotype 5
Title
Measurements
OG0005.52(4.82 to 6.32)
Additional serotypes - serotype 6A
Title
Measurements
OG00021.51(18.15 to 25.51)
Additional serotypes - serotype 7F
Title
Measurements
OG0006.24(5.49 to 7.08)
Additional serotypes - serotype 19A
Title
Measurements
OG00017.18(15.01 to 19.67)
Units
Counts
Participants
OG000189
OG001181
Title
Denominators
Categories
Common serotypes - serotype 4
Title
Measurements
OG0006912(6101.2 to 7831.4)
OG0014629(4017.2 to 5334.3)
Common serotypes - serotype 6B
Title
Measurements
OG00014224(12316.4 to 16427.3)
OG00114996(13164.1 to 17083.1)
Common serotypes - serotype 9V
Title
Measurements
OG0004485(4001.1 to 5027.5)
OG0014733(4203.3 to 5328.4)
Common serotypes - serotype 14
Title
Measurements
OG0006894(6028.3 to 7884.0)
OG0014759(4120.4 to 5497.0)
Common serotypes - serotype 18C
Title
Measurements
OG0006263(5436.4 to 7215.1)
OG0018815(7738.2 to 10041.0)
Common serotypes - serotype 19F
Title
Measurements
OG0002280(1949.4 to 2667.6)
OG0011559(1293.3 to 1878.9)
Common serotypes - serotype 23F
Title
Measurements
OG0003808(3354.7 to 4322.6)
OG0013245(2818.8 to 3735.5)
Additional serotypes - serotype 1
Title
Measurements
OG000319(271.2 to 376.0)
OG001187(160.4 to 218.6)
Additional serotypes - serotype 3
Title
Measurements
OG000114(100.4 to 129.4)
OG001202(180.9 to 226.3)
Additional serotypes - serotype 5
Title
Measurements
OG000336(270.3 to 417.6)
OG001491(426.3 to 565.3)
Additional serotypes - serotype 6A
Title
Measurements
OG0009928(8457.0 to 11654.8)
OG0017514(6350.8 to 8890.7)
Additional serotypes - serotype 7F
Title
Measurements
OG0006584(5829.4 to 7435.5)
OG00110334(9099.0 to 11736.8)
Additional serotypes - serotype 19A
Title
Measurements
OG0001276(1131.7 to 1439.0)
OG0011180(1047.5 to 1329.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: 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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.5
2-Sided
95
1.24
1.80
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
0.9
2-Sided
95
0.78
1.15
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
0.9
2-Sided
95
0.80
1.12
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.4
2-Sided
95
1.19
1.76
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
0.7
2-Sided
95
0.59
0.86
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.5
2-Sided
95
1.15
1.86
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.2
2-Sided
95
0.97
1.42
Yes
Non-Inferiority or Equivalence
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.7
2-Sided
95
1.36
2.13
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
0.6
2-Sided
95
0.48
0.67
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
0.7
2-Sided
95
0.53
0.89
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.3
2-Sided
95
1.05
1.67
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
0.6
2-Sided
95
0.53
0.76
Yes
Non-Inferiority or Equivalence
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 Group 4 - 13vPnC Group 3).
GMT Ratio
1.1
2-Sided
95
0.91
1.28
Yes
Non-Inferiority or Equivalence
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
OG002
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
OG003
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
OG004
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
OG005
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
Units
Counts
Participants
OG000110
OG001158
OG002151
OG003102
OG004270
OG005285
Title
Denominators
Categories
Tenderness Any (n=108,155, 148,102,265,283)
Title
Measurements
OG00050.9
OG00161.9
OG00245.3
OG00362.7
OG00486.8
OG00589.0
Tenderness Significant (n=92,141,133,92,221,242)
Title
Measurements
OG0007.6
OG00110.6
OG0025.3
OG003
Swelling Any (n=97,144,142,90,226,233)
Title
Measurements
OG00025.8
OG00122.2
OG00217.6
OG003
Swelling Mild (n=94,143,141,89,220,221)
Title
Measurements
OG00021.3
OG00120.3
OG00214.2
OG003
Swelling Moderate (n=94,141,135,89,219,226)
Title
Measurements
OG0009.6
OG0015.7
OG0027.4
OG003
Swelling Severe (n=90,138,131,88,211,214)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Redness Any (n=103,149,143,91,233,232)
Title
Measurements
OG00039.8
OG00134.9
OG00218.9
OG003
Redness Mild (n=99,146,143,90,226,226)
Title
Measurements
OG00031.3
OG00131.5
OG00216.8
OG003
Redness Moderate (n=94,142,135,89,218,221)
Title
Measurements
OG00012.8
OG0019.9
OG0025.9
OG003
Redness Severe (n=90,138,131,88,212,213)
Title
Measurements
OG0000.0
OG0010.0
OG0020.8
OG003
Units
Counts
Participants
OG00090
OG001131
Title
Denominators
Categories
Tenderness Any (n=87, 125)
Title
Measurements
OG00057.5
OG00155.2
Tenderness Significant (n=68, 101)
Title
Measurements
OG0008.8
OG0019.9
Swelling Any (n=73, 105)
Title
Measurements
OG00023.3
OG00117.1
Swelling Mild (n=72, 104)
Title
Measurements
OG00022.2
OG00115.4
Swelling Moderate (n=69, 102)
Title
Measurements
OG0002.9
OG0017.8
Swelling Severe (n=68, 98)
Title
Measurements
OG0000.0
OG0010.0
Redness Any (n=76, 110)
Title
Measurements
OG00035.5
OG00123.6
Redness Mild (n=74, 108)
Title
Measurements
OG00033.8
OG00118.5
Redness Moderate (n=70, 100)
Title
Measurements
OG0007.1
OG0016.0
Redness Severe (n=68, 98)
Title
Measurements
OG0000.0
OG0010.0
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
OG003
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
OG004
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
OG005
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.