Study Evaluating 13-valent Pneumococcal Conjugate Vaccine... | NCT00452790 | Trialant
NCT00452790
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Mar 24, 2011Estimated
Enrollment
708Actual
Phase
Phase 3
Conditions
Pneumococcal Infections
Interventions
13-valent Pneumococcal Conjugate Vaccine
7 valent pneumococcal conjugate vaccine
Countries
India
Protocol Section
Identification Module
NCT ID
NCT00452790
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-011
Secondary IDs
Not provided
Brief Title
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Official Title
A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2007
Primary Completion Date
Oct 2009Actual
Completion Date
Feb 2010Actual
First Submitted Date
Mar 23, 2007
First Submission Date that Met QC Criteria
Mar 26, 2007
First Posted Date
Mar 27, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 13, 2010
Results First Submitted that Met QC Criteria
Oct 13, 2010
Results First Posted Date
Nov 15, 2010Estimated
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
Mar 22, 2011
Last Update Posted Date
Mar 24, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
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) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
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 O'Brien-Fleming-adjusted, exact, 2-sided 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 19 A) are presented.
1 month after the infant series (18 weeks of age)
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
1 month after the infant series (18 weeks 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, 2-sided 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 19 A) are presented.
Other Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose 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. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Healthy infants aged 6 weeks (42-72 days) at time of enrolment
Available for the entire study period
Exclusion Criteria
Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
A previous anaphylactic reaction to any vaccine or vaccine-related component
Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
42 Days
Maximum Age
72 Days
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sector-12
Chandigarh
160 012
India
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
708 participants were enrolled and 709 were randomized into the study. One infant in the 13vPnC group was randomly assigned twice because of technical difficulties with the first random assignment. Though this infant participated in the study only once, both random assignments were included in the 354 participants in the 13vPnC group.
Recruitment Details
Not provided
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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1 month after the 3-dose infant series (18 weeks of age)
GMC for Serotype-specific Pneumococcal 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. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.
1 month after toddler dose (13 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after the dose 1 of the infant series (6 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after the dose 2 of the infant series (10 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after the dose 3 of the infant series (14 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 4 days after the toddler dose (12 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks 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 the dose 1 of the infant series (6 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks 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 the dose 2 of the infant series (10 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks 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 the dose 3 of the infant series (14 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 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 the toddler dose(12 months of age)
Sector-32 B
Chandigarh
160031
India
Bangalore
Karnataka
560 034
India
Bangalore
Karnataka
560017
India
Mumbai
Maharashtra
400 026
India
Pune
Maharashtra
411 043
India
Pune
Maharashtra
411001
India
Pune
Maharashtra
411011
India
Rajinder Nagar
New Delhi
110 060
India
Ludhiana
Punjab
141008
India
Chennai
Tamil Nadu
600034
India
Vellore
Tamil Nadu
632 004
India
FG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
FG000354 subjects
FG001355 subjects
Vaccinated Dose 1
FG000353 subjects
FG001353 subjects
Vaccinated Dose 2
FG000300 subjects
FG001300 subjects
Vaccinated Dose 3
FG000221 subjects
FG001218 subjects
COMPLETED
FG000219 subjects
FG001214 subjects
NOT COMPLETED
FG000135 subjects
FG001141 subjects
Type
Comment
Reasons
Clinical hold - consent withdrawn
FG000118 subjects
FG001123 subjects
Parent/legal guardian request
FG0008 subjects
FG0016 subjects
Failed to return
FG0004 subjects
FG0011 subjects
Protocol Violation
FG0001 subjects
FG0013 subjects
Lost to Follow-up
FG0002 subjects
FG0012 subjects
Adverse Event
FG0001 subjects
FG0012 subjects
Other reasons
FG0001 subjects
FG0012 subjects
Investigator request
FG0000 subjects
FG0011 subjects
Death
FG0000 subjects
FG0011 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000219 subjects
FG001214 subjects
COMPLETED
FG000198 subjects
FG001200 subjects
NOT COMPLETED
FG00021 subjects
FG00114 subjects
Type
Comment
Reasons
Investigator request
FG00010 subjects
FG00110 subjects
Adverse Event
FG0004 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000198 subjects
FG001200 subjects
COMPLETED
FG000198 subjects
FG001198 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
Type
Comment
Reasons
Failed to return
FG0000 subjects
FG0011 subjects
Parent/legal guardian request
FG0000 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
BG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000354
BG001355
BG002709
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
BG0001.6± 0.3
BG0011.6± 0.2
BG0021.6± 0.3
Age Continuous
Mean
Standard Deviation
weeks
Title
Denominators
Categories
Title
Measurements
BG0007.1± 1.1
BG0017.2± 1.1
BG002
Sex/Gender, Customized
Number
participants
Title
Denominators
Categories
Male
Title
Measurements
BG000184
BG001186
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 O'Brien-Fleming-adjusted, exact, 2-sided 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 19 A) 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the infant series (18 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Units
Counts
Participants
OG000206
OG001196
Title
Denominators
Categories
Common serotypes - serotype 4 (n= 203, 192)
Title
Measurements
OG00097.0(93.6 to 98.9)
OG00197.9(94.7 to 99.4)
Common serotypes - serotype 6B (n= 196,194)
Title
Measurements
OG000
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose 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. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the 3-dose infant series (18 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Primary
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) 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 (18 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
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, 2-sided 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 19 A) 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the toddler dose (13 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Other Pre-specified
GMC for Serotype-specific Pneumococcal 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. GMC (13vPnC) and corresponding 2-sided 95% CIs were 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after toddler dose (13 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks 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 dose 1 of the infant series (6 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks 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 dose 2 of the infant series (10 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks 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 dose 3 of the infant series (14 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population: all participants who received toddler dose vaccination(after 12 months). 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 (12 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks 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 at least dose 1 of the infant series vaccination (after 6 weeks. 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 dose 1 of the infant series (6 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks 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 2 of the infant series vaccination (10 weeks 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 dose 2 of the infant series (10 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks 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 3 of the infant series vaccination (14 weeks 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 dose 3 of the infant series (14 weeks 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 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 toddler dose vaccination (12 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(12 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 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
OG001
7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Time Frame
Baseline through 1 month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=6 weeks of age; Dose 2=10 weeks of age; Dose 3=14 weeks of age; Toddler Dose=12 months of age.
Description
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Infant Series 13vPnC
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
8
353
330
353
EG001
Infant Series 7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
6
353
316
353
EG002
After the Infant Series 13vPnC
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
8
353
5
353
EG003
After the Infant Series 7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
11
353
9
353
EG004
Toddler Dose 13vPnC
Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
4
198
98
198
EG005
Toddler Dose 7vPnC
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
1
200
98
200
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG0031 affected353 at risk
EG0040 affected198 at risk
EG0050 affected200 at risk
Infantile colic
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0014 affected353 at risk
EG0020 affected353 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0003 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Viral infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0021 affected353 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Heart disease congenital
Congenital, familial and genetic disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Pyrexia
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Hepatosplenomegaly
Hepatobiliary disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0022 affected353 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0022 affected353 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0022 affected353 at risk
EG003
Dysentery
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Sepsis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Septic shock
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Viral myocarditis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0022 affected353 at risk
EG003
Acute lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Breath holding
Psychiatric disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ventricular extrasystoles
Cardiac disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG0030 affected353 at risk
EG0040 affected198 at risk
EG0050 affected200 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Eye discharge
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG00021 affected353 at risk
EG00126 affected353 at risk
EG0021 affected353 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0004 affected353 at risk
EG0016 affected353 at risk
EG0020 affected353 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Perianal erythema
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Injection site pain
General disorders
MedDRA 12.1
Non-systematic Assessment
EG00075 affected353 at risk
EG00170 affected353 at risk
EG0020 affected353 at risk
EG003
Injection site swelling
General disorders
MedDRA 12.1
Non-systematic Assessment
EG00055 affected353 at risk
EG00157 affected353 at risk
EG0020 affected353 at risk
EG003
Pyrexia
General disorders
MedDRA 12.1
Non-systematic Assessment
EG00029 affected353 at risk
EG00121 affected353 at risk
EG0020 affected353 at risk
EG003
Injection site erythema
General disorders
MedDRA 12.1
Non-systematic Assessment
EG00012 affected353 at risk
EG00112 affected353 at risk
EG0020 affected353 at risk
EG003
Injection site nodule
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0005 affected353 at risk
EG00112 affected353 at risk
EG0020 affected353 at risk
EG003
Irritability
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0013 affected353 at risk
EG0020 affected353 at risk
EG003
Tenderness
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG00047 affected353 at risk
EG00137 affected353 at risk
EG0020 affected353 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG00039 affected353 at risk
EG00145 affected353 at risk
EG0022 affected353 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG00011 affected353 at risk
EG00117 affected353 at risk
EG0020 affected353 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0008 affected353 at risk
EG0015 affected353 at risk
EG0020 affected353 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0005 affected353 at risk
EG0012 affected353 at risk
EG0021 affected353 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0004 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0013 affected353 at risk
EG0020 affected353 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Otitis media
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Viral infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Omphalitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Viral diarrhoea
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Abscess neck
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Body tinea
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0021 affected353 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Impetigo
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Otitis candidiasis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Viral rash
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Crying
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Umbilical granuloma
Pregnancy, puerperium and perinatal conditions
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Penile adhesion
Reproductive system and breast disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG00037 affected353 at risk
EG00140 affected353 at risk
EG0020 affected353 at risk
EG003
Upper airway obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0013 affected353 at risk
EG0020 affected353 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0012 affected353 at risk
EG0020 affected353 at risk
EG003
Acne infantile
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Dandruff
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0011 affected353 at risk
EG0020 affected353 at risk
EG003
Macrocephaly
Congenital, familial and genetic disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Rickets
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0021 affected353 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Furuncle
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Decreased appetitie
Metabolism and nutrition disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Pallor
Vascular disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected353 at risk
EG0010 affected353 at risk
EG0020 affected353 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (any) = present at site of vaccination.
EG000217 affected347 at risk
EG001207 affected347 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; tenderness (any) = present at site of vaccination.
EG000126 affected284 at risk
EG001124 affected282 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; tenderness (any)= present at site of vaccination.
EG00076 affected204 at risk
EG00176 affected200 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (significant) = present and interfered with limb movement.
EG000144 affected341 at risk
EG001139 affected343 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant) = present and interfered with limb movement.
EG00074 affected278 at risk
EG00178 affected279 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (significant) = present and interfered with limb movement.
EG00048 affected199 at risk
EG00146 affected196 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (any) = present at site of vaccination.
EG00073 affected339 at risk
EG00177 affected342 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Induration (any) = present at site of vaccination.
EG00058 affected281 at risk
EG00152 affected278 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Induration (any) = present at site of vaccination.
EG00034 affected198 at risk
EG00127 affected195 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (mild) = 0.5 to 2.0 centimeters (cm)
EG00065 affected338 at risk
EG00165 affected340 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Induration (mild) = 0.5 to 2.0 cm
EG00047 affected281 at risk
EG00145 affected277 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Induration (mild) = 0.5 to 2.0 cm
EG00031 affected196 at risk
EG00123 affected195 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (moderate) = 2.5 to 7.0 cm
EG00016 affected331 at risk
EG00119 affected338 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Induration (moderate) = 2.5 to 7.0 cm
EG00014 affected273 at risk
EG00111 affected272 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Induration (moderate) = 2.5 to 7.0 cm
EG0005 affected193 at risk
EG0017 affected193 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm
EG0000 affected329 at risk
EG0010 affected336 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Induration (severe) >7.0 cm
EG0000 affected273 at risk
EG0010 affected271 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Induration (severe) >7.0 cm
EG0000 affected191 at risk
EG0010 affected193 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (any) = present at site of vaccination.
EG00042 affected333 at risk
EG00145 affected339 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Erythema (any) = present at site of vaccination
EG00038 affected275 at risk
EG00150 affected280 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Erythema (any) = present at site of vaccination
EG00020 affected192 at risk
EG00119 affected195 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (mild) = 0.5 to 2.0 cm
EG00038 affected333 at risk
EG00140 affected338 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Erythema (mild) = 0.5 to 2.0 cm
EG00036 affected275 at risk
EG00144 affected279 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Erythema (mild) = 0.5 to 2.0 cm
EG00020 affected192 at risk
EG00118 affected195 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (moderate) = 2.5 to 7.0 cm
EG0005 affected330 at risk
EG0016 affected337 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Erythema (moderate) = 2.5 to 7.0 cm
EG0004 affected273 at risk
EG0018 affected273 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Erythema (moderate) = 2.5 to 7.0 cm
EG0000 affected191 at risk
EG0011 affected193 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm
EG0000 affected329 at risk
EG0010 affected336 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Erythema (severe) >7.0 cm
EG0000 affected273 at risk
EG0010 affected271 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 3; Erythema (severe) >7.0 cm
EG0000 affected191 at risk
EG0010 affected193 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees Celsius [C] but ≤ 39 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees C but ≤ 39 degrees C
EG00062 affected313 at risk
EG00170 affected324 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Fever ≥ 38 degrees C but ≤ 39 degrees C
EG00027 affected263 at risk
EG00138 affected249 at risk
EG0020 affected0 at risk
EG003
Fever ≥ 38 degrees C but ≤ 39 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Fever ≥ 38 degrees C but ≤ 39 degrees C
EG00014 affected181 at risk
EG00124 affected172 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever > 39 degrees C but ≤ 40 degrees C
EG0007 affected309 at risk
EG0014 affected322 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Fever > 39 degrees C but ≤ 40 degrees C
EG0002 affected259 at risk
EG0011 affected247 at risk
EG0020 affected0 at risk
EG003
Fever > 39 degrees C but ≤ 40 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Fever > 39 degrees C but ≤ 40 degrees C
EG0000 affected179 at risk
EG0010 affected170 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever > 40 degrees C
EG0001 affected309 at risk
EG0013 affected322 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Fever > 40 degrees C
EG0000 affected259 at risk
EG0011 affected247 at risk
EG0020 affected0 at risk
EG003
Fever > 40 degrees C
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Fever > 40 degrees C
EG0000 affected179 at risk
EG0011 affected171 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG000191 affected343 at risk
EG001194 affected347 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG000135 affected281 at risk
EG001131 affected282 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00085 affected202 at risk
EG00182 affected200 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG000287 affected345 at risk
EG001277 affected347 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Irritability
EG000205 affected290 at risk
EG001203 affected291 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Irritability
EG000134 affected208 at risk
EG001140 affected208 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG000138 affected338 at risk
EG001126 affected342 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG00096 affected285 at risk
EG00174 affected275 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG00040 affected199 at risk
EG00140 affected195 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG000187 affected336 at risk
EG001192 affected343 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG000107 affected282 at risk
EG001134 affected286 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00087 affected205 at risk
EG00174 affected201 at risk
EG0020 affected0 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
D011008
Pneumococcal Infections
Ancestor Terms
ID
Term
D013290
Streptococcal Infections
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
Ancestor Terms
ID
Term
D022242
Pneumococcal Vaccines
D022541
Streptococcal Vaccines
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D017778
Vaccines, Combined
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
Parent/legal guardian request
FG0001 subjects
FG0013 subjects
Lost to Follow-up
FG0004 subjects
FG0010 subjects
Failed to return
FG0001 subjects
FG0010 subjects
Other reasons
FG0001 subjects
FG0010 subjects
1 subjects
7.1
± 1.1
370
Female
Title
Measurements
BG000169
BG001169
BG002338
Unknown
Title
Measurements
BG0001
BG0010
BG0021
84.7
(78.8 to 89.5)
OG00187.1(81.5 to 91.5)
Common serotypes - serotype 9V (n= 204,195)
Title
Measurements
OG00092.6(88.1 to 95.8)
OG00194.4(90.1 to 97.2)
Common serotypes - serotype 14 (n= 185,186)
Title
Measurements
OG00091.4(86.3 to 95.0)
OG00193.5(89.0 to 96.6)
Common serotypes - serotype 18C (n= 204,188)
Title
Measurements
OG00095.1(91.1 to 97.6)
OG00193.1(88.4 to 96.3)
Common serotypes - serotype 19F (n= 200,188)
Title
Measurements
OG00095.0(91.0 to 97.6)
OG00194.7(90.4 to 97.4)
Common serotypes - serotype 23F (n= 202,186)
Title
Measurements
OG00090.1(85.1 to 93.9)
OG00189.2(83.8 to 93.3)
Additional serotypes - serotype 1 (n= 206,195)
Title
Measurements
OG00096.6(93.1 to 98.6)
OG0010.5(0.0 to 2.8)
Additional serotypes - serotype 3 (n= 201,187)
Title
Measurements
OG00087.6(82.1 to 91.8)
OG0012.1(0.6 to 5.4)
Additional serotypes - serotype 5 (n= 201,185)
Title
Measurements
OG00085.1(79.3 to 89.7)
OG00124.3(18.3 to 31.2)
Additional serotypes - serotype 6A (n= 200,191)
Title
Measurements
OG00090.0(84.9 to 93.8)
OG00136.1(29.3 to 43.4)
Additional serotypes - serotype 7F (n= 203,192)
Title
Measurements
OG00098.0(95.0 to 99.5)
OG0012.6(0.8 to 6.0)
Additional serotypes - serotype 19 A (n= 204,190)
Title
Measurements
OG00099.5(97.3 to 100.0)
OG00184.7(78.8 to 89.6)
Units
Counts
Participants
OG000206
OG001196
Title
Denominators
Categories
Common serotypes - serotype 4 (n= 203,192)
Title
Measurements
OG0002.19(1.95 to 2.46)
OG0012.58(2.26 to 2.95)
Common serotypes - serotype 6B (n= 196,194)
Title
Measurements
OG0001.45(1.20 to 1.75)
OG0011.56(1.28 to 1.89)
Common serotypes - serotype 9V (n= 204,195)
Title
Measurements
OG0001.34(1.19 to 1.50)
OG0011.46(1.28 to 1.65)
Common serotypes - serotype 14 (n= 185,186)
Title
Measurements
OG0002.84(2.35 to 3.43)
OG0012.39(1.98 to 2.90)
Common serotypes - serotype 18C (n= 204,188)
Title
Measurements
OG0001.61(1.42 to 1.82)
OG0011.70(1.47 to 1.96)
Common serotypes - serotype 19F (n= 200,188)
Title
Measurements
OG0002.25(1.97 to 2.56)
OG0012.47(2.11 to 2.89)
Common serotypes - serotype 23F (n= 202,186)
Title
Measurements
OG0001.38(1.18 to 1.60)
OG0011.46(1.25 to 1.70)
Additional serotypes - serotype 1 (n= 206,195)
Title
Measurements
OG0001.95(1.72 to 2.22)
OG0010.03(0.03 to 0.04)
Additional serotypes - serotype 3 (n= 201,195)
Title
Measurements
OG0000.80(0.72 to 0.90)
OG0010.05(0.05 to 0.06)
Additional serotypes - serotype 5 (n= 201,195)
Title
Measurements
OG0000.93(0.82 to 1.06)
OG0010.20(0.18 to 0.23)
Additional serotypes - serotype 6A (n= 200,195)
Title
Measurements
OG0001.44(1.25 to 1.66)
OG0010.28(0.25 to 0.31)
Additional serotypes - serotype 7F (n= 203,195)
Title
Measurements
OG0002.27(2.05 to 2.33)
OG0010.06(0.05 to 0.06)
Additional serotypes - serotype 19A (n= 204,195)
Title
Measurements
OG0002.76(2.46 to 3.10)
OG0010.74(0.66 to 0.82)
Units
Counts
Participants
OG000206
OG001196
Title
Denominators
Categories
PT >=0.975 EU/mL
Title
Measurements
OG000100.0(98.2 to 100.0)
OG001100.0(98.1 to 100.0)
FHA >=3.91 EU/mL
Title
Measurements
OG000100.0(98.2 to 100.0)
OG001100.0(98.1 to 100.0)
PRN >=6 EU/mL
Title
Measurements
OG00092.7(88.2 to 95.9)
OG00195.9(92.1 to 98.2)
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
Units
Counts
Participants
OG000193
OG001196
Title
Denominators
Categories
Common serotypes - serotype 4 (n= 193, 196)
Title
Measurements
OG000100.0(98.1 to 100.0)
OG001100.0(98.1 to 100.0)
Common serotypes - serotype 6B (n= 192,195)
Title
Measurements
OG000100.0(98.1 to 100.0)
OG00199.5(97.2 to 100.0)
Common serotypes - serotype 9V (n= 193,196)
Title
Measurements
OG00099.5(97.1 to 100.0)
OG00199.5(97.2 to 100.0)
Common serotypes - serotype 14 (n= 193,196)
Title
Measurements
OG00099.5(97.1 to 100.0)
OG00199.5(97.2 to 100.0)
Common serotypes - serotype 18C (n= 193,196)
Title
Measurements
OG00099.5(97.1 to 100.0)
OG00199.0(96.4 to 99.9)
Common serotypes - serotype 19F (n= 193,196)
Title
Measurements
OG00097.9(94.8 to 99.4)
OG00198.0(94.9 to 99.4)
Common serotypes - serotype 23F (n= 193,196)
Title
Measurements
OG00098.4(95.5 to 99.7)
OG00199.5(97.2 to 100.0)
Additional serotypes - serotype 1 (n= 193,196)
Title
Measurements
OG00098.4(95.5 to 99.7)
OG0013.1(1.1 to 6.6)
Additional serotypes - serotype 3 (n= 193,196)
Title
Measurements
OG00090.2(85.1 to 94.0)
OG00112.9(8.5 to 18.4)
Additional serotypes - serotype 5 (n= 192,196)
Title
Measurements
OG000100.0(98.1 to 100.0)
OG00174.3(67.4 to 80.5)
Additional serotypes - serotype 6A (n= 193,196)
Title
Measurements
OG000100.0(98.1 to 100.0)
OG00192.8(88.2 to 96.0)
Additional serotypes - serotype 7F (n= 193,196)
Title
Measurements
OG00099.0(96.3 to 99.9)
OG0019.8(6.0 to 14.9)
Additional serotypes - serotype 19 A (n= 193,196)
Title
Measurements
OG000100.0(98.1 to 100.0)
OG00198.5(95.5 to 99.7)
Units
Counts
Participants
OG000193
OG001196
Title
Denominators
Categories
Common serotypes - serotype 4 (n= 193, 196)
Title
Measurements
OG0005.33(4.69 to 6.04)
OG0015.85(5.13 to 6.68)
Common serotypes - serotype 6B (n= 192, 195)
Title
Measurements
OG00012.24(10.60 to 14.13)
OG00111.60(9.95 to 13.53)
Common serotypes - serotype 9V (n= 193,196)
Title
Measurements
OG0003.01(2.68 to 3.37)
OG0013.33(2.96 to 3.75)
Common serotypes - serotype 14 (n= 193,196)
Title
Measurements
OG00010.59(9.21 to 12.18)
OG00110.95(9.41 to 12.74)
Common serotypes - serotype 18C (n= 193,196)
Title
Measurements
OG0002.63(2.33 to 2.97)
OG0012.98(2.65 to 3.34)
Common serotypes - serotype 19F (n= 193,196)
Title
Measurements
OG0008.38(7.11 to 9.87)
OG0015.65(4.84 to 6.58)
Common serotypes - serotype 23F (n= 193,196)
Title
Measurements
OG0004.27(3.66 to 4.98)
OG0015.31(4.66 to 6.04)
Additional serotypes - serotype 1 (n= 193,196)
Title
Measurements
OG0005.10(4.39 to 5.92)
OG0010.04(0.04 to 0.05)
Additional serotypes - serotype 3 (n= 193,196)
Title
Measurements
OG0000.91(0.81 to 1.03)
OG0010.09(0.08 to 0.11)
Additional serotypes - serotype 5 (n= 192,196)
Title
Measurements
OG0003.58(3.20 to 4.00)
OG0010.64(0.55 to 0.75)
Additional serotypes - serotype 6A (n= 193,196)
Title
Measurements
OG0008.13(7.11 to 9.28)
OG0011.87(1.62 to 2.17)
Additional serotypes - serotype 7F (n= 193,196)
Title
Measurements
OG0004.81(4.27 to 5.42)
OG0010.06(0.05 to 0.08)
Additional serotypes - serotype 19A (n= 193,196)
Title
Measurements
OG00014.12(12.45 to 16.01)
OG0013.56(3.14 to 4.05)
Units
Counts
Participants
OG000353
OG001353
Title
Denominators
Categories
Tenderness: Any (n= 347,347)
Title
Measurements
OG00062.5
OG00159.7
Tenderness: Significant (n= 341,343)
Title
Measurements
OG00042.2
OG00140.5
Induration: Any (n= 339,342)
Title
Measurements
OG00021.5
OG00122.5
Induration: Mild (n= 338,340)
Title
Measurements
OG00019.2
OG00119.1
Induration: Moderate (n= 331,338)
Title
Measurements
OG0004.8
OG0015.6
Induration: Severe (n= 329,336)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n= 333,339)
Title
Measurements
OG00012.6
OG00113.3
Erythema: Mild (n= 333,338)
Title
Measurements
OG00011.4
OG00111.8
Erythema: Moderate (n= 330,337)
Title
Measurements
OG0001.5
OG0011.8
Erythema: Severe (n= 329,336)
Title
Measurements
OG0000.0
OG0010.0
Any of the above (n= 349,348)
Title
Measurements
OG00066.8
OG00165.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.483
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.698
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.782
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.729
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.819
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.904
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.690
95
No
Superiority or Other
Units
Counts
Participants
OG000300
OG001300
Title
Denominators
Categories
Tenderness: Any (n= 284,282)
Title
Measurements
OG00044.4
OG00144.0
Tenderness: Significant (n= 278,279)
Title
Measurements
OG00026.6
OG00128.0
Induration: Any (n= 281,278)
Title
Measurements
OG00020.6
OG00118.7
Induration: Mild (n= 281,277)
Title
Measurements
OG00016.7
OG00116.2
Induration: Moderate (n= 273,272)
Title
Measurements
OG0005.1
OG0014.0
Induration: Severe (n= 273,271)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n= 275,280)
Title
Measurements
OG00013.8
OG00117.9
Erythema: Mild (n= 275,279)
Title
Measurements
OG00013.1
OG00115.8
Erythema: Moderate (n= 273,273)
Title
Measurements
OG0001.5
OG0012.9
Erythema: Severe (n= 273,271)
Title
Measurements
OG0000.0
OG0010.0
Any of the above (n= 285,286)
Title
Measurements
OG00051.6
OG00153.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.933
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.776
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.596
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.909
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.683
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.203
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.399
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.382
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.738
95
No
Superiority or Other
Units
Counts
Participants
OG000221
OG001218
Title
Denominators
Categories
Tenderness: Any (n= 204,200)
Title
Measurements
OG00037.3
OG00138.0
Tenderness: Significant (n= 199,196)
Title
Measurements
OG00024.1
OG00123.5
Induration: Any (n= 198,195)
Title
Measurements
OG00017.2
OG00113.8
Induration: Mild (n= 196,195)
Title
Measurements
OG00015.8
OG00111.8
Induration: Moderate (n= 193,193)
Title
Measurements
OG0002.6
OG0013.6
Induration: Severe (n= 191,193)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n= 192,195)
Title
Measurements
OG00010.4
OG0019.7
Erythema: Mild (n= 192,195)
Title
Measurements
OG00010.4
OG0019.2
Erythema: Moderate (n= 191,193)
Title
Measurements
OG0000.0
OG0010.5
Erythema: Severe (n= 191,193)
Title
Measurements
OG0000.0
OG0010.0
Any of the above (n= 206,202)
Title
Measurements
OG00043.2
OG00142.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.918
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.906
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.404
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.305
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.771
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.867
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.735
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.842
95
No
Superiority or Other
Units
Counts
Participants
OG000198
OG001200
Title
Denominators
Categories
Tenderness: Any (n= 174,176)
Title
Measurements
OG00029.9
OG00130.7
Tenderness: Significant (n= 171,170)
Title
Measurements
OG00015.8
OG00117.1
Induration: Any (n= 173,176)
Title
Measurements
OG00019.7
OG00117.6
Induration: Mild (n= 170,175)
Title
Measurements
OG00015.9
OG00114.9
Induration: Moderate (n= 170,171)
Title
Measurements
OG0005.3
OG0017.6
Induration: Severe (n= 167,169)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n= 174,176)
Title
Measurements
OG00014.9
OG00114.2
Erythema: Mild (n= 172,175)
Title
Measurements
OG00012.2
OG00110.9
Erythema: Moderate (n= 169,170)
Title
Measurements
OG0003.6
OG0014.1
Erythema: Severe (n= 167,169)
Title
Measurements
OG0000.0
OG0010.0
Any of the above (n= 177,178)
Title
Measurements
OG00036.7
OG00141.0
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
Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.908
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.772
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.681
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.881
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.509
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.880
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.739
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.446
95
No
Superiority or Other
Units
Counts
Participants
OG000353
OG001353
Title
Denominators
Categories
Fever >=38 but <=39 degrees C (n= 313,324)
Title
Measurements
OG00019.8
OG00121.6
Fever >39 but <=40 degrees C (n= 309,322)
Title
Measurements
OG0002.3
OG0011.2
Fever >40 degrees C (n= 309,322)
Title
Measurements
OG0000.3
OG0010.9
Decreased appetite (n= 343,347)
Title
Measurements
OG00055.7
OG00155.9
Irritability (n= 345,347)
Title
Measurements
OG00083.2
OG00179.8
Increased sleep (n= 338,342)
Title
Measurements
OG00040.8
OG00136.8
Decreased sleep (n= 336,343)
Title
Measurements
OG00055.7
OG00156.0
Any systemic event (n= 350,348)
Title
Measurements
OG00094.3
OG00190.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of fever >=38 but <=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.625
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >39 but <=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.375
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.624
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.282
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.307
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.939
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.085
95
No
Superiority or Other
Units
Counts
Participants
OG000300
OG001300
Title
Denominators
Categories
Fever >=38 but <=39 degrees C (n= 263,249)
Title
Measurements
OG00010.3
OG00115.3
Fever >39 but <=40 degrees C (n= 259,247)
Title
Measurements
OG0000.8
OG0010.4
Fever >40 degrees C (n= 259,247)
Title
Measurements
OG0000.0
OG0010.4
Decreased appetite (n= 281,282)
Title
Measurements
OG00048.0
OG00146.5
Irritability (n= 290,291)
Title
Measurements
OG00070.7
OG00169.8
Increased sleep (n= 285,275)
Title
Measurements
OG00033.7
OG00126.9
Decreased sleep (n= 282,286)
Title
Measurements
OG00037.9
OG00146.9
Any systemic event (n= 294,297)
Title
Measurements
OG00080.6
OG00180.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of fever >= 38 but <= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.111
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >39 but <= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.488
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.736
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.856
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.098
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.034
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
Units
Counts
Participants
OG000221
OG001218
Title
Denominators
Categories
Fever >=38 but <=39 degrees C (n= 181,172)
Title
Measurements
OG0007.7
OG00114.0
Fever >39 but <=40 degrees C (n= 179,170)
Title
Measurements
OG0000.0
OG0010.0
Fever >40 degrees C (n= 179,171)
Title
Measurements
OG0000.0
OG0010.6
Decreased appetite (n= 202,200)
Title
Measurements
OG00042.1
OG00141.0
Irritability (n= 208,208)
Title
Measurements
OG00064.4
OG00167.3
Increased sleep (n= 199,195)
Title
Measurements
OG00020.1
OG00120.5
Decreased sleep (n= 205,201)
Title
Measurements
OG00042.4
OG00136.8
Any systemic event (n= 213,209)
Title
Measurements
OG00075.1
OG00178.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of fever >= 38 but <= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.085
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >39 but <= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.489
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.840
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.605
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.265
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.422
95
No
Superiority or Other
Units
Counts
Participants
OG000198
OG001200
Title
Denominators
Categories
Fever >=38 but <=39 degrees C (n= 161,154)
Title
Measurements
OG0005.6
OG0016.5
Fever >39 but <=40 degrees (n= 160,152)
Title
Measurements
OG0000.6
OG0010.0
Fever >40 degrees C (n= 160,152)
Title
Measurements
OG0000.0
OG0010.0
Decreased appetite (n= 174,179)
Title
Measurements
OG00028.7
OG00124.6
Irritability (n= 174,183)
Title
Measurements
OG00038.5
OG00135.0
Increased sleep (n= 171,170)
Title
Measurements
OG00012.3
OG0019.4
Decreased sleep (n= 172,178)
Title
Measurements
OG00022.7
OG00127.0
Any systemic event (n= 179,186)
Title
Measurements
OG00054.7
OG00152.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in incidence rates of fever >= 38 but <= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.815
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >39 but <= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
>0.99
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of fever >40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.401
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.511
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.487
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.
Fisher Exact
0.388
95
No
Superiority or Other
OG000
OG001
Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.