Study Evaluating 13-valent Pneumococcal Conjugate Vaccine... | NCT00475033 | Trialant
NCT00475033
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Apr 21, 2011Estimated
Enrollment
603Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal Conjugate Vaccine
Interventions
13-valent Pneumococcal Conjugate Vaccine
7-valent pneumococcal conjugate vaccine
Countries
Canada
Protocol Section
Identification Module
NCT ID
NCT00475033
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-3008
Secondary IDs
Not provided
Brief Title
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
Official Title
A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Canada
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2007
Primary Completion Date
May 2009Actual
Completion Date
May 2009Actual
First Submitted Date
May 15, 2007
First Submission Date that Met QC Criteria
May 15, 2007
First Posted Date
May 17, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 4, 2010
Results First Submitted that Met QC Criteria
May 4, 2010
Results First Posted Date
Jun 4, 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
Apr 18, 2011
Last Update Posted Date
Apr 21, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.
13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Other Outcomes
Measure
Description
Time Frame
Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month old infants (42 to 98 days)
Available for the duration of the study and reachable by telephone
Exclusion Criteria:
Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
Receipt of blood products or gamma globulin
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
42 Days
Maximum Age
98 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
Trial Manager
For Canada, clintrialparticipation@wyeth.com
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Calgary
Alberta
T3B 6A8
Canada
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
Not provided
Recruitment Details
Subjects were recruited in Canada from June 2007 through November 2007.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
2
Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
1 month after the 3-dose Infant Series (7 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
1 month after the 3-dose infant series (7 months of age)
1 month after the toddler dose of NeisVac-C® (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
1 month after the toddler dose (13 months of age)
Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
1 month after the 3-dose infant series (7 months of age)
1 month after the 3-dose infant series (7 months of age)
Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
1 month after the 3-dose infant series (7 months of age)
Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
1 month after the toddler dose (13 months of age)
Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
1 month after the toddler dose (13 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Within 4 days after dose (2 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Within 4 days after dose (4 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Within 4 days after dose (6 months of age)
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Within 4 days after dose (12 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Within 4 days after dose (2 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Within 4 days after dose (4 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Within 4 days after dose (6 months of age)
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
FG000300 subjects
FG001303 subjects
Vaccinated Dose 1
FG000300 subjects
FG001303 subjects
Vaccinated Dose 2
FG000297 subjects
FG001296 subjects
Vaccinated Dose 3
FG000293 subjects
FG001294 subjects
COMPLETED
FG000293 subjects
FG001290 subjects
NOT COMPLETED
FG0007 subjects
FG00113 subjects
Type
Comment
Reasons
Failed to return
FG0003 subjects
FG0014 subjects
Parent or legal guardian request
FG0001 subjects
FG0015 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
Adverse Event
FG0000 subjects
FG0012 subjects
After the Infant Series
Type
Comment
Milestone Data
STARTED
FG000293 subjects
FG001290 subjects
Withdrawn After Infant Series
FG0006 subjects
FG0018 subjects
COMPLETED
FG000287 subjects
FG001282 subjects
NOT COMPLETED
FG0006 subjects
FG0018 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0014 subjects
Parent or legal guardian request
FG0002 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000287 subjectsVaccinated Toddler Dose
FG001282 subjectsVaccinated Toddler Dose
COMPLETED
FG000283 subjects
FG001282 subjects
NOT COMPLETED
FG0004 subjects
FG0010 subjects
Type
Comment
Reasons
Parent or legal guardian request
FG0002 subjects
FG0010 subjects
Failed to return
FG0001 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
BG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000300
BG001303
BG002603
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Age at enrollment
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0002.1± 0.3
BG0012.1± 0.3
BG0022.1± 0.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000143
BG001152
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 Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000284
OG001278
Title
Denominators
Categories
Title
Measurements
OG00096.8(94.1 to 98.5)
OG00199.3(97.4 to 99.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
-2.4
2-Sided
95
-5.3
-0.1
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
Primary
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
GMT
1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Primary
Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Secondary
Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-toddler dose antibody concentration (titer) to the given antigen.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after the toddler dose of NeisVac-C® (13 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
Secondary
Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
GMT
1 month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.
Posted
Geometric Mean
95% Confidence Interval
GMC μg/mL
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by μg/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% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.
The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.
Posted
Geometric Mean
95% Confidence Interval
GMC μg/mL
1 month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Primary
Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
GMC EU/mL
1 month after the 3-dose Infant Series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Primary
Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Primary
Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Posted
Geometric Mean
95% Confidence Interval
GMC µg/mL
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Secondary
Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series
Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration (titer) to the given antigen.
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (2 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (4 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (6 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (12 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (2 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (4 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (6 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Pre-specified
Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)
Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.
Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.
Posted
Number
percentage of subjects
Within 4 days after dose (12 months of age)
ID
Title
Description
OG000
13vPnC
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Time Frame
Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 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
13vPnC Infant Series
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273.
5
300
273
300
EG001
7vPnC Infant Series
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279.
5
303
279
303
EG002
13vPnC After the Infant Series
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
11
299
20
299
EG003
7vPnC After the Infant Series
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
7
301
16
301
EG004
13vPnC Toddler Dose
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199.
2
286
199
286
EG005
7vPnC Toddler Dose
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193.
2
280
193
280
EG006
13vPnC Toddler Dose 6-Month Follow-up
Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
7
299
6
299
EG007
7vPnC Toddler Dose 6-Month Follow-up
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
3
301
4
301
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG0030 affected301 at risk
EG0040 affected286 at risk
EG0050 affected280 at risk
EG0060 affected299 at risk
EG0070 affected301 at risk
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Developmental delay
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected300 at risk
EG0013 affected303 at risk
EG0022 affected299 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0021 affected299 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Meningitis meningococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Eye swelling
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0022 affected299 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Physical testicle examination abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Complex partial seizures
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG0031 affected301 at risk
EG0040 affected286 at risk
EG0050 affected280 at risk
EG0060 affected299 at risk
EG0070 affected301 at risk
Cyanosis
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Plagiocephaly
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0005 affected300 at risk
EG0019 affected303 at risk
EG0020 affected299 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0013 affected303 at risk
EG0020 affected299 at risk
EG003
Eye discharge
Eye disorders
MedDRA
Non-systematic Assessment
EG0007 affected300 at risk
EG0014 affected303 at risk
EG0020 affected299 at risk
EG003
Eye oedema
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Hypermetropia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected300 at risk
EG0016 affected303 at risk
EG0020 affected299 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00013 affected300 at risk
EG0013 affected303 at risk
EG0023 affected299 at risk
EG003
Dental discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00030 affected300 at risk
EG00129 affected303 at risk
EG0021 affected299 at risk
EG003
Faecal volume increased
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0006 affected300 at risk
EG0017 affected303 at risk
EG0020 affected299 at risk
EG003
Gingival cyst
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Infantile spitting up
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0017 affected303 at risk
EG0020 affected299 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00016 affected300 at risk
EG00114 affected303 at risk
EG0020 affected299 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00022 affected300 at risk
EG00119 affected303 at risk
EG0020 affected299 at risk
EG003
Vomiting neonatal
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Vomiting projectile
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Feeling abnormal
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Feeling hot
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Influenza like illness
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site bruising
General disorders
MedDRA
Non-systematic Assessment
EG0004 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG00015 affected300 at risk
EG00114 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site induration
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site mass
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site reaction
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0004 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Irritability
General disorders
MedDRA
Non-systematic Assessment
EG00018 affected300 at risk
EG00112 affected303 at risk
EG0020 affected299 at risk
EG003
Malaise
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0013 affected303 at risk
EG0020 affected299 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Peripheral coldness
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG00033 affected300 at risk
EG00143 affected303 at risk
EG0020 affected299 at risk
EG003
Tenderness
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Allergy to metals
Immune system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Food allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0023 affected299 at risk
EG003
Milk allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0021 affected299 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00012 affected300 at risk
EG00111 affected303 at risk
EG0020 affected299 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Candida nappy rash
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Conjunctivitis infective
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected300 at risk
EG0014 affected303 at risk
EG0020 affected299 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0008 affected300 at risk
EG00110 affected303 at risk
EG0020 affected299 at risk
EG003
Eye infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected300 at risk
EG0015 affected303 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00013 affected300 at risk
EG00112 affected303 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Fungal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Impetigo
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0013 affected303 at risk
EG0020 affected299 at risk
EG003
Incision site infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Localised infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected300 at risk
EG0013 affected303 at risk
EG0020 affected299 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00068 affected300 at risk
EG00160 affected303 at risk
EG0020 affected299 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected300 at risk
EG0019 affected303 at risk
EG0020 affected299 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Paronychia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Roseola
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected300 at risk
EG0015 affected303 at risk
EG0020 affected299 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Skin candida
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG00060 affected300 at risk
EG00153 affected303 at risk
EG0024 affected299 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Varicella
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Viral skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Accidental needle stick
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Physical examination abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0015 affected303 at risk
EG0020 affected299 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Head titubation
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Tremor
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Perineal laceration
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Crying
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0015 affected303 at risk
EG0020 affected299 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Listless
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Tearfulness
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Genital labial adhesions
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG00029 affected300 at risk
EG00122 affected303 at risk
EG0021 affected299 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG00031 affected300 at risk
EG00121 affected303 at risk
EG0021 affected299 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0013 affected303 at risk
EG0020 affected299 at risk
EG003
Pharyngeal ulceration
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG00023 affected300 at risk
EG00120 affected303 at risk
EG0020 affected299 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Dandruff
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG00012 affected300 at risk
EG0017 affected303 at risk
EG0021 affected299 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected300 at risk
EG0012 affected303 at risk
EG0021 affected299 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG00019 affected300 at risk
EG00124 affected303 at risk
EG0021 affected299 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0015 affected303 at risk
EG0020 affected299 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG00014 affected300 at risk
EG00119 affected303 at risk
EG0020 affected299 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0012 affected303 at risk
EG0020 affected299 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Seborrhoea
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Skin discoloration
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Skin nodule
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Skin warm
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0004 affected300 at risk
EG0013 affected303 at risk
EG0021 affected299 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected299 at risk
EG003
Coxsackie viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Injection site infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Measles
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Measles post vaccine
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Viraemia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Positional plagiocephaly
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Movement disorder
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Livedo reticularis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected299 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected299 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.
EG000125 affected281 at risk
EG001124 affected283 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (any)
EG00099 affected264 at risk
EG00187 affected266 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (any)
EG00067 affected245 at risk
EG00172 affected257 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.
EG00012 affected270 at risk
EG00111 affected274 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant)
EG0009 affected248 at risk
EG0019 affected252 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (significant)
EG0009 affected238 at risk
EG0012 affected244 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.
EG00016 affected271 at risk
EG00120 affected276 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (any)
EG00027 affected251 at risk
EG00129 affected253 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (any)
EG00028 affected243 at risk
EG00125 affected250 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 centimeters (cm) to 2.0 cm.
EG00015 affected270 at risk
EG00115 affected275 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (mild)
EG00026 affected251 at risk
EG00129 affected253 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (mild)
EG00027 affected243 at risk
EG00124 affected250 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 cm to 7.0 cm.
EG0002 affected267 at risk
EG0017 affected274 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (moderate)
EG0002 affected245 at risk
EG0011 affected252 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (moderate)
EG0002 affected238 at risk
EG0013 affected244 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 affected266 at risk
EG0010 affected273 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (severe)
EG0000 affected245 at risk
EG0010 affected252 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (severe)
EG0000 affected237 at risk
EG0010 affected244 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.
EG00030 affected270 at risk
EG00140 affected275 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (any)
EG00047 affected258 at risk
EG00147 affected257 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (any)
EG00040 affected244 at risk
EG00145 affected253 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 cm to 2.0 cm.
EG00029 affected270 at risk
EG00139 affected275 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (mild)
EG00043 affected256 at risk
EG00146 affected257 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (mild)
EG00040 affected244 at risk
EG00143 affected253 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 cm to 7.0 cm.
EG0001 affected266 at risk
EG0012 affected273 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (moderate)
EG0005 affected247 at risk
EG0012 affected252 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (moderate)
EG0001 affected237 at risk
EG0012 affected244 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 affected266 at risk
EG0010 affected273 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (severe)
EG0000 affected245 at risk
EG0010 affected252 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (severe)
EG0000 affected237 at risk
EG0010 affected244 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
EG00024 affected269 at risk
EG00125 affected273 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 2; Fever ≥38 degrees C but ≤39 degrees C
EG00020 affected249 at risk
EG00119 affected255 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
EG00021 affected237 at risk
EG00114 affected244 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
EG0002 affected267 at risk
EG0010 affected273 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
EG0001 affected245 at risk
EG0011 affected253 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
EG0001 affected237 at risk
EG0012 affected244 at risk
EG0020 affected0 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever >40 degrees C
EG0000 affected266 at risk
EG0010 affected273 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 affected245 at risk
EG0010 affected252 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 affected237 at risk
EG0010 affected244 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG000119 affected279 at risk
EG001102 affected283 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG00073 affected254 at risk
EG00182 affected262 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00083 affected249 at risk
EG00179 affected253 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG000235 affected291 at risk
EG001239 affected288 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG000201 affected283 at risk
EG001197 affected281 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Irritability
EG000181 affected266 at risk
EG001178 affected270 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG000180 affected286 at risk
EG001189 affected292 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG000143 affected263 at risk
EG001144 affected275 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG00091 affected255 at risk
EG001103 affected258 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG00082 affected276 at risk
EG00178 affected276 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00066 affected256 at risk
EG00181 affected261 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00075 affected251 at risk
EG00172 affected254 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc
1-800-718-1021
ClinicalTrials.govCallCenter@pfizer.com
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
2 subjects
Failed to return
FG0002 subjects
FG0011 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
Other
FG0000 subjects
FG0011 subjects
0 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
295
Male
BG000157
BG001151
BG002308
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000284
OG001278
Title
Denominators
Categories
Title
Measurements
OG000361.16(305.46 to 427.00)
OG001302.55(263.89 to 346.86)
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
Ratio of GMs (13vPnC, 7vPnC)
Ratio of geometric means
1.19
2-Sided
95
0.96
1.48
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000300
OG001303
Title
Denominators
Categories
PT ≥5 EU/mL (n=282, 277)
Title
Measurements
OG00099.6(98.0 to 100.0)
OG00199.6(98.0 to 100.0)
FHA ≥5 EU/mL (n=283, 278)
Title
Measurements
OG000100.0(98.7 to 100.0)
OG001100.0(98.7 to 100.0)
PRN ≥5 EU/mL (n=283, 277)
Title
Measurements
OG00097.9(95.4 to 99.2)
OG00196.8(93.9 to 98.5)
FIM ≥2.2 EU/mL (n=282, 275)
Title
Measurements
OG00095.4(92.2 to 97.5)
OG00197.5(94.8 to 99.0)
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
PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
0.0
2-Sided
95
-1.6
1.7
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
OG000
OG001
FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
0.0
2-Sided
95
-1.3
1.3
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
OG000
OG001
PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
1.1
2-Sided
95
-1.7
4.2
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
OG000
OG001
FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage
Difference
-2.1
2-Sided
95
-5.5
1.2
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000265
OG001268
Title
Denominators
Categories
Title
Measurements
OG000100.0(98.6 to 100.0)
OG001100.0(98.6 to 100.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
0.0
2-Sided
95
-1.4
1.4
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000265
OG001268
Title
Denominators
Categories
Title
Measurements
OG0001379.75(1235.06 to 1541.39)
OG0011083.96(962.54 to 1220.69)
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
Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)
Ratio of geometric means
1.27
2-Sided
95
1.08
1.50
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
Units
Counts
Participants
OG000300
Title
Denominators
Categories
Common serotypes - serotype 4 (n=277)
Title
Measurements
OG00097.1(94.4 to 98.7)
Common serotypes - serotype 6B (n=276)
Title
Measurements
OG00093.1(89.5 to 95.8)
Common serotypes - serotype 9V (n=277)
Title
Measurements
OG00095.3(92.1 to 97.5)
Common serotypes - serotype 14 (n=275)
Title
Measurements
OG00098.2(95.8 to 99.4)
Common serotypes - serotype 18C n=277)
Title
Measurements
OG00096.4(93.5 to 98.3)
Common serotypes - serotype 19F (n=273)
Title
Measurements
OG00098.5(96.3 to 99.6)
Common serotypes - serotype 23F (n=275)
Title
Measurements
OG00090.2(86.0 to 93.4)
Additional serotypes - serotype 1 (n=277)
Title
Measurements
OG00095.7(92.6 to 97.7)
Additional serotypes - serotype 3 (n=275)
Title
Measurements
OG00079.6(74.4 to 84.2)
Additional serotypes - serotype 5 (n=276)
Title
Measurements
OG00087.0(82.4 to 90.7)
Additional serotypes - serotype 6A (n=276)
Title
Measurements
OG00096.4(93.4 to 98.2)
Additional serotypes - serotype 7F (n=276)
Title
Measurements
OG00098.6(96.3 to 99.6)
Additional serotypes - serotype 19A (n=272)
Title
Measurements
OG00097.8(95.3 to 99.2)
Units
Counts
Participants
OG000300
Title
Denominators
Categories
Common serotypes - serotype 4 (n=277)
Title
Measurements
OG0001.46(1.33 to 1.60)
Common serotypes - serotype 6B (n=276)
Title
Measurements
OG0002.16(1.87 to 2.49)
Common serotypes - serotype 9V (n=277)
Title
Measurements
OG0001.12(1.03 to 1.22)
Common serotypes - serotype 14 (n=275)
Title
Measurements
OG0005.43(4.86 to 6.06)
Common serotypes - serotype 18C (n=277)
Title
Measurements
OG0001.37(1.23 to 1.52)
Common serotypes - serotype 19F (n=273)
Title
Measurements
OG0002.18(1.99 to 2.39)
Common serotypes - serotype 23F (n=275)
Title
Measurements
OG0001.15(1.03 to 1.30)
Additional serotypes - serotype 1 (n=277)
Title
Measurements
OG0001.82(1.63 to 2.04)
Additional serotypes - serotype 3 (n=275)
Title
Measurements
OG0000.63(0.58 to 0.70)
Additional serotypes - serotype 5 (n=276)
Title
Measurements
OG0000.90(0.81 to 0.99)
Additional serotypes - serotype 6A (n=276)
Title
Measurements
OG0001.92(1.73 to 2.12)
Additional serotypes - serotype 7F (n=276)
Title
Measurements
OG0002.26(2.09 to 2.45)
Additional serotypes - serotype 19A (n=272)
Title
Measurements
OG0002.00(1.82 to 2.19)
Units
Counts
Participants
OG000287
Title
Denominators
Categories
Common serotypes - serotype 4 (n=264)
Title
Measurements
OG000100.0(98.6 to 100.0)
Common serotypes - serotype 6B (n=263)
Title
Measurements
OG000100.0(98.6 to 100.0)
Common serotypes - serotype 9V (n=264)
Title
Measurements
OG00099.2(97.3 to 99.9)
Common serotypes - serotype 14 (n=264)
Title
Measurements
OG000100.0(98.6 to 100.0)
Common serotypes - serotype 18C (n=262)
Title
Measurements
OG00098.9(96.7 to 99.8)
Common serotypes - serotype 19F (n=263)
Title
Measurements
OG00098.1(95.6 to 99.4)
Common serotypes - serotype 23F (n=263)
Title
Measurements
OG00099.6(97.9 to 100.0)
Additional serotypes - serotype 1 (n=264)
Title
Measurements
OG000100.0(98.6 to 100.0)
Additional serotypes - serotype 3 (n=264)
Title
Measurements
OG00084.8(79.9 to 88.9)
Additional serotypes - serotype 5 (n=264)
Title
Measurements
OG00098.5(96.2 to 99.6)
Additional serotypes - serotype 6A (n=264)
Title
Measurements
OG000100.0(98.6 to 100.0)
Additional serotypes - serotype 7F (n=264)
Title
Measurements
OG000100.0(98.6 to 100.0)
Additional serotypes - serotype 19A (n=263)
Title
Measurements
OG000100.0(98.6 to 100.0)
Units
Counts
Participants
OG000287
Title
Denominators
Categories
Common serotypes - serotype 4 (n=264)
Title
Measurements
OG0002.67(2.43 to 2.92)
Common serotypes - serotype 6B (n=263)
Title
Measurements
OG0009.83(8.83 to 10.94)
Common serotypes - serotype 9V (n=264)
Title
Measurements
OG0002.04(1.87 to 2.23)
Common serotypes - serotype 14 (n=264)
Title
Measurements
OG0007.58(6.86 to 8.37)
Common serotypes - serotype 18C (n=262)
Title
Measurements
OG0002.00(1.80 to 2.21)
Common serotypes - serotype 19F (n=263)
Title
Measurements
OG0005.70(5.06 to 6.42)
Common serotypes - serotype 23F (n=263)
Title
Measurements
OG0003.59(3.21 to 4.01)
Additional serotypes - serotype 1 (n=264)
Title
Measurements
OG0003.45(3.11 to 3.82)
Additional serotypes - serotype 3 (n=264)
Title
Measurements
OG0000.74(0.67 to 0.81)
Additional serotypes - serotype 5 (n=264)
Title
Measurements
OG0002.38(2.15 to 2.62)
Additional serotypes - serotype 6A (n=264)
Title
Measurements
OG0006.47(5.87 to 7.12)
Additional serotypes - serotype 7F (n=264)
Title
Measurements
OG0003.88(3.59 to 4.21)
Additional serotypes - serotype 19A (n=263)
Title
Measurements
OG0008.36(7.61 to 9.19)
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000300
OG001303
Title
Denominators
Categories
PT (n=282, 277)
Title
Measurements
OG00046.06(42.83 to 49.53)
OG00140.37(37.24 to 43.75)
FHA (n=283,278)
Title
Measurements
OG00078.08(72.47 to 84.13)
OG00169.52(64.39 to 75.05)
PRN (n=283, 277)
Title
Measurements
OG00042.90(38.17 to 48.22)
OG00140.69(36.16 to 45.79)
FIM (n=282, 275)
Title
Measurements
OG00011.54(10.48 to 12.71)
OG00112.98(11.81 to 14.27)
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
PT: Ratio of geometric means (13vPnC, 7vPnC)
Ratio of geometric means
1.14
2-Sided
95
1.02
1.27
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
FHA: Ratio of geometric means (13vPnC, 7vPnC)
Ratio of geometric means
1.12
2-Sided
95
1.01
1.25
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
PRN: Ratio of geometric means (13vPnC, 7vPnC)
Ratio of geometric means
1.05
2-Sided
95
0.89
1.24
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG000
OG001
FIM: Ratio of geometric means (13vPnC, 7vPnC)
Ratio of geometric means
0.89
2-Sided
95
0.78
1.02
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000272
OG001266
Title
Denominators
Categories
Title
Measurements
OG00097.8(95.3 to 99.2)
OG00199.6(97.9 to 100.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
-1.8
2-Sided
95
-4.4
0.1
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000272
OG001266
Title
Denominators
Categories
Title
Measurements
OG0002.87(2.48 to 3.32)
OG0013.14(2.74 to 3.60)
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
PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)
Ratio of geometric means
0.91
2-Sided
95
0.75
1.12
CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
No
Superiority or Other
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000272
OG001266
Title
Denominators
Categories
Title
Measurements
OG00081.6(76.5 to 86.0)
OG00184.6(79.7 to 88.7)
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
PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Difference
-3.0
2-Sided
95
-9.4
3.4
Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.
Yes
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.
OG001
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000284
OG001284
Title
Denominators
Categories
Tenderness: Any (n=281, 283)
Title
Measurements
OG00044.5
OG00143.8
Tenderness: Significant (n=270, 274)
Title
Measurements
OG0004.4
OG0014.0
Induration: Any (n=271, 276)
Title
Measurements
OG0005.9
OG0017.2
Induration: Mild (n=270, 275)
Title
Measurements
OG0005.6
OG0015.5
Induration: Moderate (n=267, 274)
Title
Measurements
OG0000.7
OG0012.6
Induration: Severe (n=266, 273)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n=270, 275)
Title
Measurements
OG00011.1
OG00114.5
Erythema: Mild (n=270, 275)
Title
Measurements
OG00010.7
OG00114.2
Erythema: Moderate (n=266, 273)
Title
Measurements
OG0000.4
OG0010.7
Erythema: Severe (n=266, 273)
Title
Measurements
OG0000.0
OG0010.0
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000271
OG001268
Title
Denominators
Categories
Tenderness: Any (n=264, 266)
Title
Measurements
OG00037.5
OG00132.7
Tenderness: Significant (n=248, 252)
Title
Measurements
OG0003.6
OG0013.6
Induration: Any (n=251, 253)
Title
Measurements
OG00010.8
OG00111.5
Induration: Mild (n=251, 253)
Title
Measurements
OG00010.4
OG00111.5
Induration: Moderate (n=245, 252)
Title
Measurements
OG0000.8
OG0010.4
Induration: Severe (n=245, 252)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n=258, 257)
Title
Measurements
OG00018.2
OG00118.3
Erythema: Mild (n=256, 257)
Title
Measurements
OG00016.8
OG00117.9
Erythema: Moderate (n=247, 252)
Title
Measurements
OG0002.0
OG0010.8
Erythema: Severe (n=245, 252)
Title
Measurements
OG0000.0
OG0010.0
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Units
Counts
Participants
OG000251
OG001264
Title
Denominators
Categories
Tenderness: Any (n=245, 257)
Title
Measurements
OG00027.3
OG00128.0
Tenderness: Significant (n=238, 244)
Title
Measurements
OG0003.8
OG0010.8
Induration: Any (n=243, 250)
Title
Measurements
OG00011.5
OG00110.0
Induration: Mild (n=243, 250)
Title
Measurements
OG00011.1
OG0019.6
Induration: Moderate (n=238, 244)
Title
Measurements
OG0000.8
OG0011.2
Induration: Severe (n=237, 244)
Title
Measurements
OG0000.0
OG0010.0
Erythema: Any (n=244, 253)
Title
Measurements
OG00016.4
OG00117.8
Erythema: Mild (n=244, 253)
Title
Measurements
OG00016.4
OG00117.0
Erythema: Moderate (n=237, 244)
Title
Measurements
OG0000.4
OG0010.8
Erythema: Severe (n=237, 244)
Title
Measurements
OG0000.0
OG0010.0
7vPnC
Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.