Study Evaluating A 13-Valent Pneumococcal Conjugate Vacci... | NCT00689351 | Trialant
NCT00689351
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Jun 28, 2011Estimated
Enrollment
180Actual
Phase
Phase 2
Conditions
Pneumococcal Vaccine
Interventions
13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
Countries
South Korea
Protocol Section
Identification Module
NCT ID
NCT00689351
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-010
Secondary IDs
ID
Type
Description
Link
B1851001
Brief Title
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
Official Title
Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jun 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
Jun 2008
Primary Completion Date
Dec 2009Actual
Completion Date
Dec 2009Actual
First Submitted Date
May 29, 2008
First Submission Date that Met QC Criteria
Jun 2, 2008
First Posted Date
Jun 3, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2010
Results First Submitted that Met QC Criteria
Dec 10, 2010
Results First Posted Date
Jan 11, 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
Jun 24, 2011
Last Update Posted Date
Jun 28, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).
1 month after the infant series (7 months of age)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.
Other Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month-old-infants (42 to 98 days)
Available for the entire study period (14 months)
Exclusion Criteria:
Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
A previous severe reaction to any vaccine or vaccine-related component
Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
FG001
7vPnC
Periods
Title
Milestones
Reasons Not Completed
Infant Series of Dosing
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Care ProviderInvestigator
7-valent pneumococcal conjugate vaccine
Biological
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
2
1 month after the toddler dose (13 months of age)
1 month after the infant series (7 months of age)
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
1 month after the Toddler Dose (13 months of age)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after dose 1 (2 months of age)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after dose 2 (4 months of age)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after dose 3 (6 months of age)
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after toddler dose (12 months of age)
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after dose 1 (2 months of age)
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after dose 2 (4 months of age)
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after dose 3 (6 months of age)
Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after toddler dose (12 months of age)
Seoul
Jongno-gu
110-744
South Korea
Pfizer Investigational Site
Incheon
Jung-gu
400-711
South Korea
Pfizer Investigational Site
Kyunggi
Koyang
412-270
South Korea
Pfizer Investigational Site
Seoul
Seodaemun-gu
120-752
South Korea
Pfizer Investigational Site
Seoul
Yeongdeungpo-gu
150-950
South Korea
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
FG00091 subjects
FG00189 subjects
Vaccinated Dose 1
FG00088 subjects
FG00189 subjects
Vaccinated Dose 2
FG00086 subjects
FG00188 subjects
Vaccinated Dose 3
FG00085 subjects
FG00188 subjects
COMPLETED
FG00085 subjects
FG00188 subjects
NOT COMPLETED
FG0006 subjects
FG0011 subjects
Type
Comment
Reasons
Parent/legal guardian request
FG0005 subjects
FG0010 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG00085 subjects
FG00188 subjects
COMPLETED
FG00084 subjects
FG00188 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
Type
Comment
Reasons
Parent/legal guardian request
FG0001 subjects
FG0010 subjects
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG00084 subjects
FG00188 subjects
COMPLETED
FG00084 subjects
FG00188 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
BG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00091
BG00189
BG002180
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0002.1± 0.3
BG0012.1± 0.2
BG0022.1± 0.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00045
BG00139
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 a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).
Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
OG00091
OG00189
Title
Denominators
Categories
Serotype 4
Title
Measurements
OG000100.0(95.7 to 100.0)
OG001100.0(95.8 to 100.0)
Serotype 6B
Title
Measurements
OG000
Secondary
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.
Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Other Pre-specified
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Evaluable Infant Immunogenicity Population
Posted
Geometric Mean
95% Confidence Interval
Mcg/mL
1 month after the infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
Other Pre-specified
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Evaluable Toddler Immunogenicity Population
Posted
Geometric Mean
95% Confidence Interval
Mcg/mL
1 month after the Toddler Dose (13 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Posted
Number
percentage of participants
Within 4 days after dose 1 (2 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Posted
Number
percentage of participants
Within 4 days after dose 2 (4 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Posted
Number
percentage of participants
Within 4 days after dose 3 (6 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Posted
Number
percentage of participants
Within 4 days after toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Posted
Number
percentage of participants
Within 4 days after dose 1 (2 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Posted
Number
percentage of participants
Within 4 days after dose 2 (4 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Posted
Number
percentage of participants
Within 4 days after dose 3 (6 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Posted
Number
percentage of participants
Within 4 days after toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
Time Frame
Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age.
Description
Safety population = all randomized subjects with at least 1 dose of study treatment. 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
Infant Series 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
8
88
78
88
EG001
Infant Series 7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
9
89
75
89
EG002
After the Infant Series 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
9
88
18
88
EG003
After the Infant Series 7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
12
89
19
89
EG004
Toddler Dose 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose).
3
84
28
84
EG005
Toddler Dose 7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
3
88
36
88
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG0030 affected89 at risk
EG0040 affected84 at risk
EG0050 affected88 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Soft tissue inflammation
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0014 affected89 at risk
EG0021 affected88 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0003 affected88 at risk
EG0011 affected89 at risk
EG0021 affected88 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0012 affected89 at risk
EG0020 affected88 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0023 affected88 at risk
EG003
Kawasaki's disease
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Herpangina
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Influenza
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG0034 affected89 at risk
EG004
Supraventricular tachycardia
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 affected88 at risk
EG0012 affected89 at risk
EG0020 affected88 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Blepharitis
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Entropion
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Eye discharge
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00010 affected88 at risk
EG00110 affected89 at risk
EG0023 affected88 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0013 affected89 at risk
EG0020 affected88 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Pyrexia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0008 affected88 at risk
EG0014 affected89 at risk
EG0020 affected88 at risk
EG003
Injection site erythema
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Injection site induration
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Irritability
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Atopy
Immune system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG00024 affected88 at risk
EG00130 affected89 at risk
EG0023 affected88 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG00017 affected88 at risk
EG0019 affected89 at risk
EG0020 affected88 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG00011 affected88 at risk
EG00117 affected89 at risk
EG0023 affected88 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG00010 affected88 at risk
EG00110 affected89 at risk
EG0022 affected88 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG00012 affected88 at risk
EG0017 affected89 at risk
EG0020 affected88 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0009 affected88 at risk
EG0015 affected89 at risk
EG0020 affected88 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 affected88 at risk
EG0011 affected89 at risk
EG0021 affected88 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0012 affected89 at risk
EG0020 affected88 at risk
EG003
Otitis media
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0012 affected89 at risk
EG0020 affected88 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Varicella
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Candidiasis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Croup infectious
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Herpangina
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Viral diarrhoea
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Viral rash
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Periorbital cellulit
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Urine output decreased
Investigations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Weight decreased
Investigations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0021 affected88 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Perineal fistula
Reproductive system and breast disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00016 affected88 at risk
EG00116 affected89 at risk
EG0021 affected88 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00011 affected88 at risk
EG00117 affected89 at risk
EG0022 affected88 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0003 affected88 at risk
EG0012 affected89 at risk
EG0020 affected88 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Grunting
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Upper airway obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0008 affected88 at risk
EG0018 affected89 at risk
EG0022 affected88 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0007 affected88 at risk
EG0013 affected89 at risk
EG0020 affected88 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 affected88 at risk
EG0012 affected89 at risk
EG0020 affected88 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0016 affected89 at risk
EG0022 affected88 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0013 affected89 at risk
EG0020 affected88 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0013 affected89 at risk
EG0020 affected88 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected89 at risk
EG0020 affected88 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected89 at risk
EG0020 affected88 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; tenderness (any)=present at site of vaccination
EG00023 affected72 at risk
EG00126 affected76 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; tenderness (any)=present at site of vaccination
EG00023 affected60 at risk
EG00124 affected64 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; tenderness (any)=present at site of vaccination
EG00015 affected64 at risk
EG00116 affected59 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement
EG0006 affected68 at risk
EG0012 affected72 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement
EG0000 affected55 at risk
EG0013 affected60 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement
EG0000 affected58 at risk
EG0011 affected54 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination
EG00014 affected71 at risk
EG00118 affected73 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Swelling (any)=present at site of vaccination
EG00022 affected62 at risk
EG00118 affected63 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
Local reactions
Non-systematic Assessment
Infant Series Dose 3; Swelling (any)=present at site of vaccination
EG00018 affected65 at risk
EG00114 affected60 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 cm
EG0008 affected69 at risk
EG00118 affected73 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Swelling (mild)=0.5 to 2.0 cm
EG00018 affected61 at risk
EG00115 affected61 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Swelling (mild)=0.5 to 2.0 cm
EG00013 affected62 at risk
EG00113 affected59 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm
EG0007 affected69 at risk
EG0014 affected70 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Swelling (moderate)=2.5 to 7.0 cm
EG0004 affected56 at risk
EG0014 affected61 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Swelling (moderate)=2.5 to 7.0 cm
EG0007 affected62 at risk
EG0014 affected57 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (severe) >7.0 cm
EG0000 affected67 at risk
EG0010 affected70 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Swelling (severe) >7.0 cm
EG0000 affected55 at risk
EG0010 affected59 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Swelling (severe) >7.0 cm
EG0000 affected58 at risk
EG0010 affected53 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination.
EG00027 affected72 at risk
EG00122 affected75 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Redness (any)=present at site of vaccination
EG00020 affected61 at risk
EG00125 affected65 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Redness (any)=present at site of vaccination
EG00019 affected63 at risk
EG00116 affected61 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm
EG00023 affected70 at risk
EG00119 affected75 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Redness (mild)=0.5 to 2.0 cm
EG00018 affected61 at risk
EG00124 affected65 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Redness (mild)=0.5 to 2.0 cm
EG00012 affected60 at risk
EG00115 affected60 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm
EG0004 affected69 at risk
EG0013 affected70 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Redness (moderate)=2.5 to 7.0 cm
EG0004 affected56 at risk
EG0013 affected59 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Redness (moderate)=2.5 to 7.0 cm
EG0007 affected61 at risk
EG0013 affected54 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (severe) >7.0 cm
EG0000 affected67 at risk
EG0010 affected70 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Redness (severe) >7.0 cm
EG0000 affected55 at risk
EG0010 affected59 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Redness (severe) >7.0 cm
EG0000 affected58 at risk
EG0010 affected53 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever 38 degrees C but 39 degrees C
EG00011 affected69 at risk
EG0019 affected72 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever 38 degrees C but 39 degrees C
EG0006 affected55 at risk
EG0018 affected61 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever 38 degrees C but 39 degrees C
EG0008 affected59 at risk
EG0015 affected54 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever > 39 degrees C but 40 degrees C
EG0000 affected67 at risk
EG0010 affected70 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever > 39 degrees C but 40 degrees C
EG0000 affected55 at risk
EG0010 affected58 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever > 39 degrees C but 40 degrees C
EG0000 affected58 at risk
EG0011 affected51 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever > 40 degrees C
EG0000 affected67 at risk
EG0010 affected70 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever > 40 degrees C
EG0000 affected55 at risk
EG0010 affected58 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever > 40 degrees C
EG0000 affected58 at risk
EG0010 affected51 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG00023 affected71 at risk
EG00122 affected76 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG00016 affected59 at risk
EG00128 affected63 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00014 affected61 at risk
EG00116 affected57 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG00038 affected77 at risk
EG00156 affected79 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG00025 affected62 at risk
EG00136 affected67 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Irritability
EG00013 affected62 at risk
EG00125 affected60 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG00037 affected75 at risk
EG00130 affected77 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG00017 affected59 at risk
EG00116 affected61 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG00018 affected61 at risk
EG00112 affected57 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG00028 affected74 at risk
EG00138 affected76 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00018 affected60 at risk
EG00127 affected66 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00010 affected61 at risk
EG00117 affected58 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer Clinical Trials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquires@Pfizer.com
ID
Term
D004194
Disease
Ancestor Terms
ID
Term
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
Ancestor Terms
ID
Term
D022242
Pneumococcal Vaccines
D022541
Streptococcal Vaccines
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D017778
Vaccines, Combined
Browse Leaves
Not provided
Browse Branches
Not provided
84
Male
BG00046
BG00150
BG00296
98.8
(93.5 to 100.0)
OG001100.0(95.8 to 100.0)
Serotype 9V
Title
Measurements
OG000100.0(95.7 to 100.0)
OG001100.0(95.8 to 100.0)
Serotype 14
Title
Measurements
OG000100.0(95.7 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 18C
Title
Measurements
OG000100.0(95.7 to 100.0)
OG001100.0(95.8 to 100.0)
Serotype 19F
Title
Measurements
OG00097.6(91.6 to 99.7)
OG00198.8(93.6 to 100.0)
Serotype 23F
Title
Measurements
OG00098.8(93.5 to 100.0)
OG00198.8(93.6 to 100.0)
Serotype 1
Title
Measurements
OG000100.0(95.7 to 100.0)
OG0012.4(0.3 to 8.2)
Serotype 3
Title
Measurements
OG000100.0(95.7 to 100.0)
OG0012.4(0.3 to 8.2)
Serotype 5
Title
Measurements
OG000100.0(95.7 to 100.0)
OG00157.5(45.9 to 68.5)
Serotype 6A
Title
Measurements
OG00097.6(91.6 to 99.7)
OG00172.3(61.4 to 81.6)
Serotype 7F
Title
Measurements
OG000100.0(95.7 to 100.0)
OG0014.8(1.3 to 11.7)
Serotype 19A
Title
Measurements
OG000100.0(95.7 to 100.0)
OG001100.0(95.6 to 100.0)
Units
Counts
Participants
OG00091
OG00189
Title
Denominators
Categories
Serotype 4
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 6B
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 9V
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 14
Title
Measurements
OG00098.7(93.1 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 18C
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 19F
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 23F
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 1
Title
Measurements
OG000100.0(95.5 to 100.0)
OG0011.3(0.0 to 6.9)
Serotype 3
Title
Measurements
OG000100.0(95.5 to 100.0)
OG00112.0(5.9 to 21.0)
Serotype 5
Title
Measurements
OG000100.0(95.5 to 100.0)
OG00192.4(84.2 to 97.2)
Serotype 6A
Title
Measurements
OG00098.8(93.2 to 100.0)
OG001100.0(95.7 to 100.0)
Serotype 7F
Title
Measurements
OG000100.0(95.4 to 100.0)
OG00123.6(13.2 to 37.0)
Serotype 19A
Title
Measurements
OG000100.0(95.5 to 100.0)
OG00198.8(93.5 to 100.0)
OG00091
OG00189
Title
Denominators
Categories
Serotype 4
Title
Measurements
OG0005.40(4.62 to 6.30)
OG0016.97(5.94 to 8.18)
Serotype 6B
Title
Measurements
OG0005.71(4.64 to 7.03)
OG0014.88(3.96 to 6.01)
Serotype 9V
Title
Measurements
OG0003.33(2.90 to 3.83)
OG0013.78(3.31 to 4.33)
Serotype 14
Title
Measurements
OG00014.83(12.38 to 17.77)
OG00116.29(13.36 to 19.85)
Serotype 18C
Title
Measurements
OG0004.57(3.98 to 5.24)
OG0014.73(4.09 to 5.47)
Serotype 19F
Title
Measurements
OG0003.88(3.18 to 4.72)
OG0014.20(3.55 to 4.96)
Serotype 23F
Title
Measurements
OG0004.29(3.56 to 5.16)
OG0014.11(3.40 to 4.98)
Serotype 1
Title
Measurements
OG0007.44(6.25 to 8.85)
OG0010.02(0.02 to 0.03)
Serotype 3
Title
Measurements
OG0001.60(1.35 to 1.89)
OG0010.04(0.03 to 0.05)
Serotype 5
Title
Measurements
OG0005.06(4.37 to 5.85)
OG0010.39(0.30 to 0.49)
Serotype 6A
Title
Measurements
OG0005.73(4.64 to 7.07)
OG0010.64(0.49 to 0.82)
Serotype 7F
Title
Measurements
OG0006.97(6.07 to 8.00)
OG0010.04(0.03 to 0.05)
Serotype 19A
Title
Measurements
OG0005.94(5.13 to 6.89)
OG0012.65(2.29 to 3.06)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.77
2-Sided
95
0.62
0.97
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
1.17
2-Sided
95
0.87
1.57
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.88
2-Sided
95
0.73
1.07
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.91
2-Sided
95
0.70
1.19
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.97
2-Sided
95
0.79
1.18
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.92
2-Sided
95
0.71
1.19
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
1.04
2-Sided
95
0.80
1.36
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
329.44
2-Sided
95
242.98
446.67
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
40.79
2-Sided
95
30.27
54.97
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
13.12
2-Sided
95
9.92
17.34
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
9.01
2-Sided
95
6.46
12.56
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
165.90
2-Sided
95
122.95
223.85
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
2.24
2-Sided
95
1.83
2.75
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG00091
OG00189
Title
Denominators
Categories
Serotype 4
Title
Measurements
OG0006.46(5.29 to 7.90)
OG0018.25(6.88 to 9.89)
Serotype 6B
Title
Measurements
OG00016.81(14.36 to 19.68)
OG00115.14(11.91 to 19.25)
Serotype 9V
Title
Measurements
OG0004.59(3.91 to 5.38)
OG0014.83(4.12 to 5.67)
Serotype 14
Title
Measurements
OG00011.51(9.59 to 13.80)
OG00115.64(13.07 to 18.72)
Serotype 18C
Title
Measurements
OG0006.86(5.67 to 8.29)
OG0017.44(6.27 to 8.83)
Serotype 19F
Title
Measurements
OG0007.75(6.30 to 9.53)
OG0015.35(4.52 to 6.33)
Serotype 23F
Title
Measurements
OG00010.95(8.77 to 13.66)
OG00110.44(8.60 to 12.68)
Serotype 1
Title
Measurements
OG0009.29(7.65 to 11.28)
OG0010.04(0.03 to 0.05)
Serotype 3
Title
Measurements
OG0001.65(1.40 to 1.95)
OG0010.10(0.08 to 0.13)
Serotype 5
Title
Measurements
OG0008.92(7.62 to 10.45)
OG0011.31(1.09 to 1.56)
Serotype 6A
Title
Measurements
OG00013.58(11.28 to 16.36)
OG0013.33(2.67 to 4.14)
Serotype 7F
Title
Measurements
OG00011.17(9.33 to 13.37)
OG0010.10(0.07 to 0.14)
Serotype 19A
Title
Measurements
OG00010.12(8.55 to 11.98)
OG0012.38(2.04 to 2.78)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.78
2-Sided
95
0.60
1.02
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
1.11
2-Sided
95
0.83
1.48
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.95
2-Sided
95
0.76
1.19
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.74
2-Sided
95
0.57
0.95
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
0.92
2-Sided
95
0.72
1.19
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
1.45
2-Sided
95
1.11
1.88
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
1.05
2-Sided
95
0.78
1.40
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
234.33
2-Sided
95
176.33
311.41
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
16.63
2-Sided
95
12.19
22.69
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
6.84
2-Sided
95
5.39
8.67
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
4.08
2-Sided
95
3.07
5.43
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
110.92
2-Sided
95
77.09
159.59
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)
Student t distribution
Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Ratio of geometric means
4.25
2-Sided
95
3.39
5.33
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
Units
Counts
Participants
OG00075
OG00179
Title
Denominators
Categories
Tenderness: Any (n=23,26)
Title
Measurements
OG00031.9
OG00134.2
Tenderness: Significant (n=6,2)
Title
Measurements
OG0008.8
OG0012.8
Swelling: Any (n=14,18)
Title
Measurements
OG00019.7
OG00124.7
Swelling: Mild (n=8,18)
Title
Measurements
OG00011.6
OG00124.7
Swelling: Moderate (n=7,4)
Title
Measurements
OG00010.1
OG0015.7
Redness: Any (n=27,22)
Title
Measurements
OG00037.5
OG00129.3
Redness: Mild (n=23,19)
Title
Measurements
OG00032.9
OG00125.3
Redness: Moderate (n=4,3)
Title
Measurements
OG0005.8
OG0014.3
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
Comparison between treatments for any tenderness.
Fisher Exact
0.862
No
Superiority or Other
OG000
OG001
Comparison between treatments for significant tenderness.
Fisher Exact
0.157
No
Superiority or Other
OG000
OG001
Comparison between treatments for any swelling.
Fisher Exact
0.550
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild swelling.
Fisher Exact
0.052
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate swelling.
Fisher Exact
0.366
No
Superiority or Other
OG000
OG001
Comparison between treatments for any redness.
Fisher Exact
0.301
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild redness.
Fisher Exact
0.362
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate redness.
Fisher Exact
0.718
No
Superiority or Other
Participants
OG00062
OG00168
Title
Denominators
Categories
Tenderness: Any (n=23,24)
Title
Measurements
OG00038.3
OG00137.5
Tenderness: Significant (n=0,3)
Title
Measurements
OG0000.0
OG0015.0
Swelling: Any (n=22,18)
Title
Measurements
OG00035.5
OG00128.6
Swelling: Mild (n=18,15)
Title
Measurements
OG00029.5
OG00124.6
Swelling: Moderate (n=4,4)
Title
Measurements
OG0007.1
OG0016.6
Redness: Any (n=20,25)
Title
Measurements
OG00032.8
OG00138.5
Redness: Mild (n=18,24)
Title
Measurements
OG00029.5
OG00136.9
Redness: Moderate (n=4,3)
Title
Measurements
OG0007.1
OG0015.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison between treatments for any tenderness.
Fisher Exact
>0.99
No
Superiority or Other
OG000
OG001
Comparison between treatments for significant tenderness.
Fisher Exact
0.245
No
Superiority or Other
OG000
OG001
Comparison between treatments for any swelling.
Fisher Exact
0.447
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild swelling.
Fisher Exact
0.684
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate swelling.
Fisher Exact
>0.99
No
Superiority or Other
OG000
OG001
Comparison between treatments for any redness.
Fisher Exact
0.578
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild redness.
Fisher Exact
0.451
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate redness.
Fisher Exact
0.712
No
Superiority or Other
Participants
OG00066
OG00164
Title
Denominators
Categories
Tenderness: Any (n=15,16)
Title
Measurements
OG00023.4
OG00127.1
Tenderness: Significant (n=0,1)
Title
Measurements
OG0000.0
OG0011.9
Swelling: Any (n=18,14)
Title
Measurements
OG00027.7
OG00123.3
Swelling: Mild (n=13,13)
Title
Measurements
OG00021.0
OG00122.0
Swelling: Moderate (n=7,4)
Title
Measurements
OG00011.3
OG0017.0
Redness: Any (n=19,16)
Title
Measurements
OG00030.2
OG00126.2
Redness: Mild (n=12,15)
Title
Measurements
OG00020.0
OG00125.0
Redness: Moderate (n=7,3)
Title
Measurements
OG00011.5
OG0015.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison between treatments for any tenderness.
Fisher Exact
0.681
No
Superiority or Other
OG000
OG001
Comparison between treatments for significant tenderness.
Fisher Exact
0.482
No
Superiority or Other
OG000
OG001
Comparison between treatments for any swelling.
Fisher Exact
0.683
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild swelling.
Fisher Exact
>0.99
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate swelling.
Fisher Exact
0.533
No
Superiority or Other
OG000
OG001
Comparison between treatments for any redness.
Fisher Exact
0.692
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild redness.
Fisher Exact
0.662
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate redness.
Fisher Exact
0.331
No
Superiority or Other
Participants
OG00057
OG00157
Title
Denominators
Categories
Tenderness: Any (n=19,14)
Title
Measurements
OG00033.9
OG00125.9
Tenderness: Significant (n=3,1)
Title
Measurements
OG0005.9
OG0012.0
Swelling: Any (n=11,10)
Title
Measurements
OG00022.4
OG00118.9
Swelling: Mild (n=4,7)
Title
Measurements
OG0008.2
OG00113.5
Swelling: Moderate (n=9,4)
Title
Measurements
OG00018.4
OG0017.8
Swelling: Severe (n=1,0)
Title
Measurements
OG0002.0
OG0010.0
Redness: Any (n=15,12)
Title
Measurements
OG00028.8
OG00122.2
Redness: Mild (n=9,10)
Title
Measurements
OG00017.6
OG00118.5
Redness: Moderate (n=8,3)
Title
Measurements
OG00016.0
OG0016.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison between treatments for any tenderness.
Fisher Exact
0.409
No
Superiority or Other
OG000
OG001
Comparison between treatments for significant tenderness.
Fisher Exact
0.617
No
Superiority or Other
OG000
OG001
Comparison between treatments for any swelling.
Fisher Exact
0.807
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild swelling.
Fisher Exact
0.527
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate swelling.
Fisher Exact
0.144
No
Superiority or Other
OG000
OG001
Comparison between treatments for severe swelling.
Fisher Exact
0.495
No
Superiority or Other
OG000
OG001
Comparison between treatments for any redness.
Fisher Exact
0.506
No
Superiority or Other
OG000
OG001
Comparison between treatments for mild redness.
Fisher Exact
>0.99
No
Superiority or Other
OG000
OG001
Comparison between treatments for moderate redness.
Fisher Exact
0.200
No
Superiority or Other
OG00083
OG00186
Title
Denominators
Categories
Fever ≥38 degrees C but ≤39 degrees C (n=11,9)
Title
Measurements
OG00015.9
OG00112.5
Decreased appetite (n=23,22)
Title
Measurements
OG00032.4
OG00128.9
Irritability (n=38,56)
Title
Measurements
OG00049.4
OG00170.9
Increased sleep (n=37,30)
Title
Measurements
OG00049.3
OG00139.0
Decreased sleep (n=28,38)
Title
Measurements
OG00037.8
OG00150.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.
Fisher Exact
0.633
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased appetite.
Fisher Exact
0.721
No
Superiority or Other
OG000
OG001
Comparison between treatments for irritability.
Fisher Exact
0.009
No
Superiority or Other
OG000
OG001
Comparison between treatments for increased sleep.
Fisher Exact
0.253
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased sleep.
Fisher Exact
0.143
No
Superiority or Other
OG00064
OG00172
Title
Denominators
Categories
Fever ≥38 degrees C but ≤39 degrees C (n=6,8)
Title
Measurements
OG00010.9
OG00113.1
Decreased appetite (n=16,28)
Title
Measurements
OG00027.1
OG00144.4
Irritability (n=25,36)
Title
Measurements
OG00040.3
OG00153.7
Increased sleep (n=17,16)
Title
Measurements
OG00028.8
OG00126.2
Decreased sleep (n=18,27)
Title
Measurements
OG00030.0
OG00140.9
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
Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.
Fisher Exact
0.781
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased appetite.
Fisher Exact
0.060
No
Superiority or Other
OG000
OG001
Comparison between treatments for irritability.
Fisher Exact
0.159
No
Superiority or Other
OG000
OG001
Comparison between treatments for increased sleep.
Fisher Exact
0.839
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased sleep.
Fisher Exact
0.264
No
Superiority or Other
OG00065
OG00164
Title
Denominators
Categories
Fever ≥38 degrees C but ≤39 degrees C (n=8,5)
Title
Measurements
OG00013.6
OG0019.3
Fever >39 degrees C but ≤40 degrees C (n=0,1)
Title
Measurements
OG0000.0
OG0012.0
Decreased appetite (n=14,16)
Title
Measurements
OG00023.0
OG00128.1
Irritability (n=13,25)
Title
Measurements
OG00021.0
OG00141.7
Increased sleep (n=18,12)
Title
Measurements
OG00029.5
OG00121.1
Decreased sleep (n=10,17)
Title
Measurements
OG00016.4
OG00129.3
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
Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.
Fisher Exact
0.563
No
Superiority or Other
OG000
OG001
Comparison between treatments for fever >39 degrees C but ≤40 degrees C.
Fisher Exact
0.468
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased appetite.
Fisher Exact
0.535
No
Superiority or Other
OG000
OG001
Comparison between treatments for irritability.
Fisher Exact
0.019
No
Superiority or Other
OG000
OG001
Comparison between treatments for increased sleep.
Fisher Exact
0.398
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased sleep.
Fisher Exact
0.125
No
Superiority or Other
OG00064
OG00165
Title
Denominators
Categories
Fever ≥38 degrees C but ≤39 degrees C (n=7,10)
Title
Measurements
OG00013.7
OG00119.6
Fever >39 degrees C but ≤40 degrees C (n=1,0)
Title
Measurements
OG0002.0
OG0010.0
Decreased appetite (n=13,15)
Title
Measurements
OG00022.8
OG00127.8
Irritability (n=18,21)
Title
Measurements
OG00030.5
OG00137.5
Increased sleep (n=11,8)
Title
Measurements
OG00021.2
OG00115.4
Decreased sleep (n=11,20)
Title
Measurements
OG00020.4
OG00134.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.
Fisher Exact
0.596
No
Superiority or Other
OG000
OG001
Comparison between treatments for fever >39 degrees C but ≤40 degrees C.
Fisher Exact
>0.99
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased appetite.
Fisher Exact
0.663
No
Superiority or Other
OG000
OG001
Comparison between treatments for irritability.
Fisher Exact
0.439
No
Superiority or Other
OG000
OG001
Comparison between treatments for increased sleep.
Fisher Exact
0.613
No
Superiority or Other
OG000
OG001
Comparison between treatments for decreased sleep.