Study Evaluating A 13-Valent Pneumococcal Conjugate Vacci... | NCT00688870 | Trialant
NCT00688870
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Oct 7, 2022Actual
Enrollment
168Actual
Phase
Phase 3
Conditions
Vaccines
Pneumococcal Conjugate Vaccine
Interventions
13-valent pneumococcal conjugate vaccine (13vPnC)
7-valent pneumococcal conjugate vaccine (7vPnC)
Countries
Taiwan
Protocol Section
Identification Module
NCT ID
NCT00688870
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-3004
Secondary IDs
ID
Type
Description
Link
B1851005
Other Identifier
Alias Study Number
2008-004766-40
EudraCT Number
Brief Title
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
Official Title
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Sep 2022
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 5, 2008Actual
Primary Completion Date
Jan 13, 2010Actual
Completion Date
Jan 13, 2010Actual
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
Jan 13, 2011
Results First Submitted that Met QC Criteria
Apr 18, 2011
Results First Posted Date
May 12, 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
Sep 12, 2022
Last Update Posted Date
Oct 7, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
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 Taiwan.
13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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) are presented.
1 month after the infant series (7 months of age)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% 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) are presented.
Other Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
Antibody GMC as measured in mcg/mL 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.
1 month after the 3-dose infant series (7 months of age)
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 vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
A total of 169 subjects were screened, 168 subjects were randomly assigned in a 1:1 ratio to either the 13vPnC group (n=84) or the 7vPnC group (n=84).
Recruitment Details
Subjects were recruited in Taiwan from June 2008 to Nov 2009
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Periods
Title
Milestones
Reasons Not Completed
Infant Series
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
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
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 (7vPnC)
Biological
7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
2
1 month after toddler dose (16 months of age)
GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
Antibody GMC as measured in mcg/mL 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.
1 month after the toddler dose (16 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).
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 and redness present); Mild (0.5 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 1 of the infant series (2 Months of Age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
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 and redness present); Mild (0.5 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 of the infant series (4 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
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 and redness present); Mild (0.5 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 of the infant series (6 months of age)
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).
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 and redness present); Mild (0.5 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 the toddler dose (15 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after Dose 1 of the infant series (2 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after Dose 2 of the infant series (4 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after dose 3 of the infant series (6 months of age)
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).
Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after the toddler dose (15 months of age)
Taoyuan Hsien
333
Taiwan
FG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
FG00084 subjects
FG00184 subjects
Vaccinated Dose 1
FG00083 subjects
FG00184 subjects
Vaccinated Dose 2
FG00080 subjects
FG00184 subjects
Vaccinated Dose 3
FG00080 subjects
FG00184 subjects
COMPLETED
FG00080 subjects
FG00184 subjects
NOT COMPLETED
FG0004 subjects
FG0010 subjects
Type
Comment
Reasons
Parent or legal guardian request
FG0004 subjects
FG0010 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG00080 subjects
FG00184 subjects
COMPLETED
FG00080 subjects
FG00184 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG00080 subjects
FG00184 subjects
COMPLETED
FG00080 subjects
FG00184 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
BG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00084
BG00184
BG002168
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
BG0002.2± 0.3
BG0012.3± 0.3
BG0022.2± 0.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00040
BG00147
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Taiwan, Province Of China
Title
Measurements
BG00084
BG00184
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 Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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) are presented.
Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Units
Counts
Participants
OG00080
OG00183
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG00098.8(93.2 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 6B
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Common serotypes - serotype 4
Chan and Zhang
Difference
-1.2
2-Sided
95
-6.8
3.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Secondary
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% 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) are presented.
Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after toddler dose (16 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
Antibody GMC as measured in mcg/mL 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.
Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
GMC mcg/mL
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
Antibody GMC as measured in mcg/mL 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.
Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
GMC mcg/mL
1 month after the toddler dose (16 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).
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 and redness present); Mild (0.5 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 population: all participants who received dose 1 of the infant series vaccination (2 months of age). number analyzed= number of participants reporting yes for at least 1 day or no for all days.
Posted
Number
percentage of participants
Within 4 days after Dose 1 of the infant series (2 Months of Age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
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 and redness present); Mild (0.5 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 population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Posted
Number
percentage of participants
Within 4 Days after Dose 2 of the infant series (4 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
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 and redness present); Mild (0.5 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 population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Posted
Number
percentage of participants
Within 4 days after Dose 3 of the infant series (6 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).
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 and redness present); Mild (0.5 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 population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Posted
Number
percentage of participants
Within 4 days after the toddler dose (15 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.
Posted
Number
percentage of participants
Within 4 days after Dose 1 of the infant series (2 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Posted
Number
percentage of participants
Within 4 days after Dose 2 of the infant series (4 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Posted
Number
percentage of participants
Within 4 days after dose 3 of the infant series (6 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).
Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Posted
Number
percentage of participants
Within 4 days after the toddler dose (15 months of age)
ID
Title
Description
OG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Time Frame
Baseline through 1 month after last study vaccination (16 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=15 months of age.
Description
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Infant Series 13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
4
83
81
83
EG001
Infant Series 7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
4
84
77
84
EG002
After the Infant Series 13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
12
83
11
83
EG003
After the Infant Series 7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
9
84
16
84
EG004
Toddler Dose 13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose).
0
80
39
80
EG005
Toddler Dose 7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
3
84
47
84
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ileus
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG0030 affected84 at risk
EG0040 affected80 at risk
EG0050 affected84 at risk
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0013 affected84 at risk
EG0022 affected83 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0011 affected84 at risk
EG0021 affected83 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0022 affected83 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Pneumonia primary atypical
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0021 affected83 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Intestinal functional disorder
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0022 affected83 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Roseola
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Herpangina
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Testicular retraction
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Tenderness (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (any) = present at site of vaccination.
EG00025 affected80 at risk
EG00126 affected76 at risk
EG0020 affected0 at risk
EG0030 affected0 at risk
EG004
Tenderness (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; tenderness (any) = present at site of vaccination.
EG00017 affected72 at risk
EG00117 affected76 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; tenderness (any) = present at site of vaccination.
EG00013 affected67 at risk
EG00112 affected67 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (significant) = present and interfered with limb movement.
EG0004 affected75 at risk
EG0017 affected75 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Tenderness (significant) = present and interfered with limb movement.
EG0002 affected69 at risk
EG0011 affected71 at risk
EG0020 affected0 at risk
EG003
Tenderness (signficant)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Tenderness (significant) = present and interfered with limb movement.
EG0000 affected65 at risk
EG0011 affected65 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (any) = present at site of vaccination.
EG00020 affected78 at risk
EG0019 affected76 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Swelling (any) = present at site of vaccination.
EG0009 affected70 at risk
EG00111 affected72 at risk
EG0020 affected0 at risk
EG003
Swelling (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Swelling (any) = present at site of vaccination.
EG00011 affected65 at risk
EG0013 affected65 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (mild) = 0.5 to 2.0 cm
EG00019 affected78 at risk
EG0019 affected76 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Swelling (mild) = 0.5 to 2.0 cm
EG0009 affected70 at risk
EG00111 affected72 at risk
EG0020 affected0 at risk
EG003
Swelling (mild)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Swelling (mild) = 0.5 to 2.0 cm
EG00010 affected65 at risk
EG0013 affected65 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (moderate) = 2.5 to 7.0 cm
EG0001 affected74 at risk
EG0010 affected74 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Swelling (moderate) = 2.5 to 7.0 cm
EG0000 affected69 at risk
EG0010 affected71 at risk
EG0020 affected0 at risk
EG003
Swelling (moderate)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Swelling (moderate) = 2.5 to 7.0 cm
EG0002 affected65 at risk
EG0010 affected64 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Swelling (severe) = >7.0 cm
EG0000 affected74 at risk
EG0010 affected74 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Swelling (severe) = >7.0 cm
EG0000 affected69 at risk
EG0010 affected71 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (any) = present at site of vaccination.
EG00023 affected77 at risk
EG00122 affected76 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Redness (any) = present at site of vaccination.
EG00012 affected70 at risk
EG00115 affected74 at risk
EG0020 affected0 at risk
EG003
Redness (any)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Redness (any) = present at site of vaccination.
EG00014 affected67 at risk
EG0019 affected65 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (mild) = 0.5 to 2.0 cm
EG00020 affected77 at risk
EG00120 affected76 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Redness (mild) = 0.5 to 2.0 cm
EG00012 affected70 at risk
EG00113 affected74 at risk
EG0020 affected0 at risk
EG003
Redness (mild)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Redness (mild) = 0.5 to 2.0 cm
EG00012 affected66 at risk
EG0019 affected65 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (moderate) = 2.5 to 7.0 cm
EG0006 affected74 at risk
EG0012 affected74 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Redness (moderate) = 2.5 to 7.0 cm
EG0000 affected69 at risk
EG0012 affected71 at risk
EG0020 affected0 at risk
EG003
Redness (moderate)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Redness (moderate) = 2.5 to 7.0 cm
EG0003 affected66 at risk
EG0010 affected64 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Redness (severe) = >7.0 cm
EG0000 affected74 at risk
EG0010 affected74 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Redness (severe) = >7.0 cm
EG0000 affected69 at risk
EG0010 affected71 at risk
EG0020 affected0 at risk
EG003
Redness (severe)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Redness (severe) = >7.0 cm
EG0000 affected65 at risk
EG0010 affected64 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees C but ≤ 39 degrees C
EG00044 affected80 at risk
EG00139 affected78 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Fever ≥ 38 degrees C but ≤ 39 degrees C
EG00038 affected73 at risk
EG00133 affected76 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Fever ≥ 38 degrees C but ≤ 39 degrees C
EG00021 affected66 at risk
EG00115 affected66 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever > 39 degrees C but ≤ 40 degrees C
EG0001 affected74 at risk
EG0011 affected74 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Fever > 39 degrees C but ≤ 40 degrees C
EG0002 affected69 at risk
EG0012 affected72 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Fever > 39 degrees C but ≤ 40 degrees C
EG0003 affected65 at risk
EG0016 affected66 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever > 40 degrees C
EG0000 affected74 at risk
EG0010 affected74 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Fever > 40 degrees C
EG0000 affected69 at risk
EG0010 affected71 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Fever > 40 degrees C
EG0000 affected65 at risk
EG0011 affected64 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG00039 affected78 at risk
EG00145 affected81 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG00037 affected73 at risk
EG00146 affected82 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00030 affected69 at risk
EG00139 affected75 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG00052 affected80 at risk
EG00156 affected80 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Irritability
EG00042 affected75 at risk
EG00146 affected80 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Irritability
EG00029 affected68 at risk
EG00134 affected71 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG00041 affected77 at risk
EG00141 affected81 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG00030 affected73 at risk
EG00133 affected76 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG00027 affected66 at risk
EG00126 affected70 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG00035 affected79 at risk
EG00132 affected78 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00030 affected71 at risk
EG00125 affected77 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00021 affected68 at risk
EG00123 affected69 at risk
EG0020 affected0 at risk
EG003
Swelling (severe)
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
Infant Series Dose 3; Swelling (severe) = >7.0 cm
EG0000 affected65 at risk
EG0010 affected64 at risk
EG0020 affected0 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0005 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Milk allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG00031 affected83 at risk
EG00153 affected84 at risk
EG0020 affected83 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected83 at risk
EG0014 affected84 at risk
EG0020 affected83 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0015 affected84 at risk
EG0020 affected83 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0014 affected84 at risk
EG0020 affected83 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0013 affected84 at risk
EG0020 affected83 at risk
EG003
Roseola
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Abscess limb
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Viral rash
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected83 at risk
EG0014 affected84 at risk
EG0021 affected83 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected83 at risk
EG0012 affected84 at risk
EG0021 affected83 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0011 affected84 at risk
EG0021 affected83 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0012 affected84 at risk
EG0020 affected83 at risk
EG003
Allergic respiratory disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Tonsillar inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG00010 affected83 at risk
EG00111 affected84 at risk
EG0025 affected83 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0005 affected83 at risk
EG0016 affected84 at risk
EG0020 affected83 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected83 at risk
EG0015 affected84 at risk
EG0023 affected83 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0013 affected84 at risk
EG0021 affected83 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0011 affected84 at risk
EG0020 affected83 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Gastric disorder
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Intestinal functional disorder
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Otitis externa
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Scleroderma
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0021 affected83 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected83 at risk
EG0010 affected84 at risk
EG0020 affected83 at risk
EG003
Geometric Mean Concentration Outcome Measures were identified as secondary analysis in the study protocol, but are included to maintain consistency with other postings for this program.
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
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
87
Male
BG00044
BG00137
BG00281
168
100.0
(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 9V
Title
Measurements
OG00098.8(93.2 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 14
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 18C
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 19F
Title
Measurements
OG00098.8(93.2 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 23F
Title
Measurements
OG00095.0(87.7 to 98.6)
OG001100.0(95.7 to 100.0)
Additional Serotypes - Serotype 1
Title
Measurements
OG00098.8(93.2 to 100.0)
OG0012.4(0.3 to 8.4)
Additional Serotypes - Serotype 3
Title
Measurements
OG00097.5(91.3 to 99.7)
OG0012.4(0.3 to 8.4)
Additional Serotypes - Serotype 5
Title
Measurements
OG00098.8(93.2 to 100.0)
OG00161.5(49.8 to 72.3)
Additional Serotypes - Serotype 6A
Title
Measurements
OG000100.0(95.5 to 100.0)
OG00177.1(66.6 to 85.6)
Additional Serotypes - Serotype 7F
Title
Measurements
OG000100.0(95.5 to 100.0)
OG0012.4(0.3 to 8.4)
Additional Serotypes - Serotype 19A
Title
Measurements
OG000100.0(95.5 to 100.0)
OG001100.0(95.6 to 100.0)
OG000
OG001
Common serotypes - serotype 6B
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 9V
Chan and Zhang
Difference
-1.2
2-Sided
95
-6.8
3.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 14
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 18C
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 19F
Chan and Zhang
Difference
-1.2
2-Sided
95
-6.8
3.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 23F
Chan and Zhang
Difference
-5.0
2-Sided
95
-12.3
-0.3
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 1
Chan and Zhang
Difference
96.3
2-Sided
95
89.4
99.2
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 3
Chan and Zhang
Difference
95.1
2-Sided
95
87.7
98.6
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 5
Chan and Zhang
Difference
37.2
2-Sided
95
26.2
48.9
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 6A
Chan and Zhang
Difference
22.9
2-Sided
95
14.4
33.4
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 7F
Chan and Zhang
Difference
97.6
2-Sided
95
91.6
99.7
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 19A
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.5
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Units
Counts
Participants
OG00079
OG00184
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG00098.7(93.1 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 6B
Title
Measurements
OG000100.0(95.4 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 9V
Title
Measurements
OG00098.7(93.1 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 14
Title
Measurements
OG000100.0(95.4 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 18C
Title
Measurements
OG000100.0(95.4 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 19F
Title
Measurements
OG00098.7(93.1 to 100.0)
OG001100.0(95.7 to 100.0)
Common Serotypes - Serotype 23F
Title
Measurements
OG000100.0(95.4 to 100.0)
OG001100.0(95.7 to 100.0)
Additional Serotypes - Serotype 1
Title
Measurements
OG000100.0(95.4 to 100.0)
OG0015.0(1.4 to 12.3)
Additional Serotypes - Serotype 3
Title
Measurements
OG00096.2(89.3 to 99.2)
OG00113.8(7.1 to 23.3)
Additional Serotypes - Serotype 5
Title
Measurements
OG000100.0(95.4 to 100.0)
OG00190.4(81.9 to 95.7)
Additional Serotypes - Serotype 6A
Title
Measurements
OG000100.0(95.4 to 100.0)
OG001100.0(95.7 to 100.0)
Additional Serotypes - Serotype 7F
Title
Measurements
OG000100.0(95.4 to 100.0)
OG0016.3(2.1 to 14.0)
Additional Serotypes - Serotype 19A
Title
Measurements
OG000100.0(95.4 to 100.0)
OG00198.8(93.5 to 100.0)
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
Common serotypes - serotype 4
Chan and Zhang
Difference
-1.3
2-Sided
95
-6.9
3.1
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 6B
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.4
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 9V
Chan and Zhang
Difference
-1.3
2-Sided
95
-6.9
3.1
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 14
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.4
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 18C
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.4
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 19F
Chan and Zhang
Difference
-1.3
2-Sided
95
-6.9
3.1
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Common serotypes - serotype 23F
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.4
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 1
Chan and Zhang
Difference
95.0
2-Sided
95
87.7
98.6
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 3
Chan and Zhang
Difference
82.5
2-Sided
95
72.0
90.1
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 5
Chan and Zhang
Difference
9.6
2-Sided
95
3.8
18.1
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 6A
Chan and Zhang
Difference
0.0
2-Sided
95
-4.6
4.4
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 7F
Chan and Zhang
Difference
93.8
2-Sided
95
86.0
97.9
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000
OG001
Additional serotypes - serotype 19A
Chan and Zhang
Difference
1.2
2-Sided
95
-3.4
6.5
Non-Inferiority or Equivalence (legacy)
Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Units
Counts
Participants
OG00080
OG00183
Title
Denominators
Categories
Common serotypes - serotype 4
Title
Measurements
OG0002.89(2.45 to 3.42)
OG0014.64(4.00 to 5.37)
Common serotypes - serotype 6B
Title
Measurements
OG0004.37(3.58 to 5.33)
OG0014.82(4.09 to 5.67)
Common serotypes - serotype 9V
Title
Measurements
OG0001.97(1.70 to 2.27)
OG0012.92(2.55 to 3.34)
Common serotypes - serotype 14
Title
Measurements
OG0009.76(8.34 to 11.43)
OG00111.59(9.79 to 13.71)
Common serotypes - serotype 18C
Title
Measurements
OG0002.39(2.04 to 2.82)
OG0013.07(2.64 to 3.56)
Common serotypes - serotype 19F
Title
Measurements
OG0003.60(3.00 to 4.32)
OG0014.77(4.17 to 5.47)
Common serotypes - serotype 23F
Title
Measurements
OG0001.93(1.56 to 2.37)
OG0013.25(2.78 to 3.80)
Additional serotypes - serotype 1
Title
Measurements
OG0004.14(3.45 to 4.96)
OG0010.02(0.02 to 0.02)
Additional serotypes - serotype 3
Title
Measurements
OG0001.20(1.00 to 1.45)
OG0010.05(0.04 to 0.06)
Additional serotypes - serotype 5
Title
Measurements
OG0002.47(2.09 to 2.92)
OG0010.43(0.35 to 0.53)
Additional serotypes - serotype 6A
Title
Measurements
OG0004.57(3.92 to 5.34)
OG0010.79(0.63 to 0.99)
Additional serotypes - serotype 7F
Title
Measurements
OG0003.67(3.14 to 4.29)
OG0010.04(0.03 to 0.05)
Additional serotypes - serotype 19A
Title
Measurements
OG0003.69(3.20 to 4.24)
OG0012.46(2.13 to 2.84)
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
Common serotypes - serotype 4
ratio of GMCs
0.62
2-Sided
95
0.50
0.78
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 6B
ratio of GMCs
0.91
2-Sided
95
0.70
1.17
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 9V
ratio of GMCs
0.67
2-Sided
95
0.55
0.82
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 14
ratio of GMCs
0.84
2-Sided
95
0.67
1.06
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 18C
ratio of GMCs
0.78
2-Sided
95
0.63
0.97
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 19F
ratio of GMCs
0.75
2-Sided
95
0.60
0.94
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 23F
ratio of GMCs
0.59
2-Sided
95
0.46
0.77
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 1
ratio of GMCs
202.58
2-Sided
95
157.04
261.32
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 3
ratio of GMCs
24.11
2-Sided
95
18.46
31.49
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 5
ratio of GMCs
5.69
2-Sided
95
4.37
7.41
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 6A
ratio of GMCs
5.82
2-Sided
95
4.42
7.67
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 7F
ratio of GMCs
96.10
2-Sided
95
75.60
122.17
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 19A
ratio of GMCs
1.50
2-Sided
95
1.23
1.83
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
Units
Counts
Participants
OG00079
OG00184
Title
Denominators
Categories
Common serotypes - serotype 4
Title
Measurements
OG0004.06(3.34 to 4.93)
OG0016.34(5.26 to 7.65)
Common serotypes - serotype 6B
Title
Measurements
OG00013.62(11.08 to 16.73)
OG00113.28(10.87 to 16.21)
Common serotypes - serotype 9V
Title
Measurements
OG0003.18(2.66 to 3.80)
OG0013.88(3.27 to 4.60)
Common serotypes - serotype 14
Title
Measurements
OG0008.17(6.53 to 10.22)
OG00112.04(9.90 to 14.63)
Common serotypes - serotype 18C
Title
Measurements
OG0003.67(3.00 to 4.49)
OG0014.87(4.01 to 5.90)
Common serotypes - serotype 19F
Title
Measurements
OG0008.07(6.58 to 9.90)
OG0017.41(6.16 to 8.92)
Common serotypes - serotype 23F
Title
Measurements
OG0005.51(4.46 to 6.81)
OG0017.97(6.55 to 9.68)
Additional serotypes - serotype 1
Title
Measurements
OG0007.62(6.30 to 9.21)
OG0010.03(0.02 to 0.03)
Additional serotypes - serotype 3
Title
Measurements
OG0001.29(1.09 to 1.53)
OG0010.12(0.09 to 0.16)
Additional serotypes - serotype 5
Title
Measurements
OG0004.57(3.87 to 5.39)
OG0010.95(0.80 to 1.13)
Additional serotypes - serotype 6A
Title
Measurements
OG00011.55(9.66 to 13.81)
OG0013.79(3.01 to 4.76)
Additional serotypes - serotype 7F
Title
Measurements
OG0005.91(4.95 to 7.06)
OG0010.06(0.04 to 0.07)
Additional serotypes - serotype 19A
Title
Measurements
OG0008.82(7.45 to 10.43)
OG0011.98(1.69 to 2.32)
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
Common serotypes - serotype 4
ratio of GMC
0.64
2-Sided
95
0.49
0.84
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 6B
ratio of GMCs
1.03
2-Sided
95
0.77
1.36
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 9V
ratio of GMCs
0.82
2-Sided
95
0.64
1.05
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 14
ratio of GMCs
0.68
2-Sided
95
0.51
0.91
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 18C
ratio of GMCs
0.75
2-Sided
95
0.57
0.99
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 19F
ratio of GMCs
1.09
2-Sided
95
0.83
1.43
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Common serotypes - serotype 23F
ratio of GMCs
0.69
2-Sided
95
0.52
0.92
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 1
ratio of GMCs
303.73
2-Sided
95
213.63
431.83
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 3
ratio of GMCs
10.65
2-Sided
95
7.77
14.62
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 5
ratio of GMCs
4.79
2-Sided
95
3.78
6.08
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 6A
ratio of GMCs
3.05
2-Sided
95
2.28
4.08
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 7F
ratio of GMCs
105.00
2-Sided
95
75.60
145.84
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
OG000
OG001
Additional serotypes - serotype 19A
ratio of GMCs
4.45
2-Sided
95
3.54
5.60
Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Superiority or Other (legacy)
Units
Counts
Participants
OG00083
OG00184
Title
Denominators
Categories
Tenderness - Any
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00031.3
OG00134.2
Tenderness - Significant
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG0005.3
OG001
Swelling - Any
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00025.6
OG001
Swelling - Mild
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00024.4
OG001
Swelling - Moderate
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0001.4
OG001
Swelling - Severe
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0000.0
OG001
Redness - Any
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00029.9
OG001
Redness - Mild
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00026.0
OG001
Redness - Moderate
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0008.1
OG001
Redness - Severe
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0000.0
OG001
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
For Tenderness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.735
95
Superiority or Other (legacy)
OG000
OG001
For Tenderness - Significant, Fisher exact test was used to calculate p-value.
Fisher Exact
0.533
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.039
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
0.059
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
0.275
95
Superiority or Other (legacy)
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Units
Counts
Participants
OG00080
OG00184
Title
Denominators
Categories
Tenderness - Any
ParticipantsOG00080
ParticipantsOG00184
Title
Measurements
OG00023.6
OG00122.4
Tenderness - Significant
ParticipantsOG00069
ParticipantsOG00171
Title
Measurements
OG0002.9
OG001
Swelling - Any
ParticipantsOG00070
ParticipantsOG00172
Title
Measurements
OG00012.9
OG001
Swelling - Mild
ParticipantsOG00070
ParticipantsOG00172
Title
Measurements
OG00012.9
OG001
Swelling - Moderate
ParticipantsOG00069
ParticipantsOG00171
Title
Measurements
OG0000.0
OG001
Swelling - Severe
ParticipantsOG00069
ParticipantsOG00171
Title
Measurements
OG0000.0
OG001
Redness - Any
ParticipantsOG00070
ParticipantsOG00174
Title
Measurements
OG00017.1
OG001
Redness - Mild
ParticipantsOG00070
ParticipantsOG00174
Title
Measurements
OG00017.1
OG001
Redness - Moderate
ParticipantsOG00069
ParticipantsOG00171
Title
Measurements
OG0000.0
OG001
Redness - Severe
ParticipantsOG00069
ParticipantsOG00171
Title
Measurements
OG0000.0
OG001
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
For Tenderness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Tenderness - Significant, Fisher exact test was used to calculate p-value.
Fisher Exact
0.617
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.810
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
0.810
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.674
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
0.497
95
Superiority or Other (legacy)
Units
Counts
Participants
OG00080
OG00184
Title
Denominators
Categories
Tenderness - Any
ParticipantsOG00067
ParticipantsOG00167
Title
Measurements
OG00019.4
OG00117.9
Tenderness - Significant
ParticipantsOG00065
ParticipantsOG00165
Title
Measurements
OG0000.0
OG001
Swelling - Any
ParticipantsOG00065
ParticipantsOG00165
Title
Measurements
OG00016.9
OG001
Swelling - Mild
ParticipantsOG00065
ParticipantsOG00165
Title
Measurements
OG00015.4
OG001
Swelling - Moderate
ParticipantsOG00065
ParticipantsOG00164
Title
Measurements
OG0003.1
OG001
Swelling - Severe
ParticipantsOG00065
ParticipantsOG00164
Title
Measurements
OG0000.0
OG001
Redness - Any
ParticipantsOG00067
ParticipantsOG00165
Title
Measurements
OG00020.9
OG001
Redness - Mild
ParticipantsOG00066
ParticipantsOG00165
Title
Measurements
OG00018.2
OG001
Redness - Moderate
ParticipantsOG00066
ParticipantsOG00164
Title
Measurements
OG0004.5
OG001
Redness - Severe
ParticipantsOG00065
ParticipantsOG00164
Title
Measurements
OG0000.0
OG001
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
For Tenderness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Tenderness - Significant, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.044
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
0.076
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
0.496
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.361
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
0.635
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
0.244
95
Superiority or Other (legacy)
Units
Counts
Participants
OG00080
OG00184
Title
Denominators
Categories
Tenderness - Any
ParticipantsOG00064
ParticipantsOG00175
Title
Measurements
OG00010.9
OG00122.7
Tenderness - Significant
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0000.0
OG001
Swelling - Any
ParticipantsOG00063
ParticipantsOG00170
Title
Measurements
OG0007.9
OG001
Swelling - Mild
ParticipantsOG00063
ParticipantsOG00170
Title
Measurements
OG0006.3
OG001
Swelling - Moderate
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0001.6
OG001
Swelling - Severe
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0000.0
OG001
Redness - Any
ParticipantsOG00065
ParticipantsOG00170
Title
Measurements
OG00015.4
OG001
Redness - Mild
ParticipantsOG00065
ParticipantsOG00170
Title
Measurements
OG00013.8
OG001
Redness - Moderate
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0001.6
OG001
Redness - Severe
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0000.0
OG001
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
For Tenderness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.076
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.735
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Swelling - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
0.477
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Any, Fisher exact test was used to calculate p-value.
Fisher Exact
0.805
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Mild, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Redness - Moderate, Fisher exact test was used to calculate p-value.
Fisher Exact
0.477
95
Superiority or Other (legacy)
Units
Counts
Participants
OG00083
OG00184
Title
Denominators
Categories
Fever >=38 but <=39 degrees C
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00055.0
OG00150.0
Fever >39 but <=40 degrees C
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0001.4
OG001
Fever >40 degrees C
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0000.0
OG001
Decreased appetite
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00050.0
OG001
Irritability
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00065.0
OG001
Increased sleep
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00053.2
OG001
Decreased sleep
ParticipantsOG00083
ParticipantsOG00184
Title
Measurements
OG00044.3
OG001
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
For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
0.633
95
Superiority or Other (legacy)
OG000
OG001
For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Decreased appetite, Fisher exact test was used to calculate p-value.
Fisher Exact
0.527
95
Superiority or Other (legacy)
OG000
OG001
For Irritability, Fisher exact test was used to calculate p-value.
Fisher Exact
0.613
95
Superiority or Other (legacy)
OG000
OG001
For Increased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
0.753
95
Superiority or Other (legacy)
OG000
OG001
For Decreased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
0.748
95
Superiority or Other (legacy)
Units
Counts
Participants
OG00080
OG00184
Title
Denominators
Categories
Fever >=38 but <=39 degrees C
ParticipantsOG00080
ParticipantsOG00184
Title
Measurements
OG00052.1
OG00143.4
Fever >39 but <=40 degrees C
ParticipantsOG00069
ParticipantsOG00172
Title
Measurements
OG0002.9
OG001
Fever >40 degrees C
ParticipantsOG00069
ParticipantsOG00171
Title
Measurements
OG0000.0
OG001
Decreased appetite
ParticipantsOG00080
ParticipantsOG00184
Title
Measurements
OG00050.7
OG001
Irritability
ParticipantsOG00080
ParticipantsOG00184
Title
Measurements
OG00056.0
OG001
Increased sleep
ParticipantsOG00080
ParticipantsOG00184
Title
Measurements
OG00041.1
OG001
Decreased sleep
ParticipantsOG00071
ParticipantsOG00177
Title
Measurements
OG00042.3
OG001
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
For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
0.327
95
Superiority or Other (legacy)
OG000
OG001
For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Decreased appetite, Fisher exact test was used to calculate p-value.
Fisher Exact
0.522
95
Superiority or Other (legacy)
OG000
OG001
For Irritability, Fisher exact test was used to calculate p-value.
Fisher Exact
0.872
95
Superiority or Other (legacy)
OG000
OG001
For Increased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
0.868
95
Superiority or Other (legacy)
OG000
OG001
For Decreased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
0.237
95
Superiority or Other (legacy)
Units
Counts
Participants
OG00080
OG00184
Title
Denominators
Categories
Fever >=38 but <=39 degrees C
ParticipantsOG00066
ParticipantsOG00166
Title
Measurements
OG00031.8
OG00122.7
Fever >39 but <=40 degrees C
ParticipantsOG00065
ParticipantsOG00166
Title
Measurements
OG0004.6
OG001
Fever >40 degrees C
ParticipantsOG00065
ParticipantsOG00164
Title
Measurements
OG0000.0
OG001
Decreased appetite
ParticipantsOG00069
ParticipantsOG00175
Title
Measurements
OG00043.5
OG001
Irritability
ParticipantsOG00068
ParticipantsOG00171
Title
Measurements
OG00042.6
OG001
Increased sleep
ParticipantsOG00066
ParticipantsOG00170
Title
Measurements
OG00040.9
OG001
Decreased sleep
ParticipantsOG00068
ParticipantsOG00169
Title
Measurements
OG00030.9
OG001
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
For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
0.329
95
Superiority or Other (legacy)
OG000
OG001
For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
0.492
95
Superiority or Other (legacy)
OG000
OG001
For Fever >40 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
0.496
95
Superiority or Other (legacy)
OG000
OG001
For Decreased appetite, Fisher exact test was used to calculate p-value.
Fisher Exact
0.322
95
Superiority or Other (legacy)
OG000
OG001
For Irritability, Fisher exact test was used to calculate p-value.
Fisher Exact
0.610
95
Superiority or Other (legacy)
OG000
OG001
For Increased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
0.726
95
Superiority or Other (legacy)
OG000
OG001
For Decreased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
0.855
95
Superiority or Other (legacy)
Units
Counts
Participants
OG00080
OG00184
Title
Denominators
Categories
Fever >=38 but <=39 degrees C
ParticipantsOG00065
ParticipantsOG00170
Title
Measurements
OG00029.2
OG00121.4
Fever >39 but <=40 degrees C
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0003.2
OG001
Fever >40 degrees C
ParticipantsOG00063
ParticipantsOG00169
Title
Measurements
OG0000.0
OG001
Decreased appetite
ParticipantsOG00065
ParticipantsOG00175
Title
Measurements
OG00027.7
OG001
Irritability
ParticipantsOG00065
ParticipantsOG00174
Title
Measurements
OG00027.7
OG001
Increased sleep
ParticipantsOG00066
ParticipantsOG00172
Title
Measurements
OG00016.7
OG001
Decreased sleep
ParticipantsOG00064
ParticipantsOG00174
Title
Measurements
OG00017.2
OG001
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
For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
0.326
95
Superiority or Other (legacy)
OG000
OG001
For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Decreased appetite, Fisher exact test was used to calculate p-value.
Fisher Exact
0.714
95
Superiority or Other (legacy)
OG000
OG001
For Irritability, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Increased sleep, Fisher exact test was used to calculate p-value.
Fisher Exact
>0.99
95
Superiority or Other (legacy)
OG000
OG001
For Decreased sleep, Fisher exact test was used to calculate p-value.