A Trial Evaluating a 7-valent Pneumococcal Conjugate Vacc... | NCT01250756 | Trialant
NCT01250756
Sponsor
Pfizer
Status
Completed
Last Update Posted
Feb 26, 2013Estimated
Enrollment
321Actual
Phase
Phase 4
Conditions
Healthy Subjects
Interventions
7-pneumococcal conjugate vaccine (7vPnC)
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
DTaP
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01250756
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1841007
Secondary IDs
ID
Type
Description
Link
B1841007, 6107A1-4000
Brief Title
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Official Title
A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2010
Primary Completion Date
Mar 2012Actual
Completion Date
Mar 2012Actual
First Submitted Date
Nov 29, 2010
First Submission Date that Met QC Criteria
Nov 29, 2010
First Posted Date
Dec 1, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 22, 2013
Results First Submitted that Met QC Criteria
Jan 22, 2013
Results First Posted Date
Feb 26, 2013Estimated
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
Jan 22, 2013
Last Update Posted Date
Feb 26, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.
Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
2
Experimental
Active comparator
Biological: DTaP
Interventions
Name
Type
Description
Arm Group Labels
Other Names
7-pneumococcal conjugate vaccine (7vPnC)
Biological
0.5 mL per dose, 4 doses
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
1 month after the infant series
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
1 month after the infant series
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
Available for entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
3 Months
Maximum Age
6 Months
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Tsubaki Children's Clinic
Chiba
Chiba
Japan
Sotobo Children's Clinic
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Periods
Title
Milestones
Reasons Not Completed
Infant Series
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
Biological
0.5 mL per dose, 4 doses
1
DTaP
Biological
0.5 mL per dose, 4 doses
2
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
1 month after the infant series
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
1 month after the toddler dose
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
1 month after the toddler dose
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Pre-toddler dose, 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
1 month after the catch-up dose 3
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
1 month after the catch-up dose 3
Within 7 days after Dose 1 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Within 7 days after Dose 2 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Within 7 days after Dose 3 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Within 7 days after the toddler dose
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Within 7 days after Catch-up Dose 1
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Within 7 days after Catch-up Dose 2
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Within 7 days after Catch-up Dose 3
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Dose 1 of the infant series
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Dose 2 of the infant series
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Dose 3 of the infant series
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after the toddler dose
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Catch-up Dose 1
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Catch-up Dose 2
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Catch-up Dose 3
Isumi
Chiba
Japan
Matsuyama Red Cross Hospital
Matsuyama
Ehime
Japan
Kiyomatsu Childrens Clinic
Fukuoka
Fukuoka
Japan
National Hospital Organization Fukuoka National Hospital
Fukuoka
Fukuoka
Japan
Shindo Children's Clinic
Fukuoka
Fukuoka
Japan
Takasaki Clinic Pedatrics and Child Health
Fukuoka
Fukuoka
Japan
Yamashita Pediatrics Clinic
Itoshima
Fukuoka
Japan
Yokoyama Children's Clinic
Kasuga
Fukuoka
Japan
Furuta Children's Clinic
Sapporo
Hokkaido
Japan
Tenshi Hospital
Sapporo
Hokkaido
Japan
Watanabe Pediatric Allergy Clinic
Sapporo
Hokkaido
Japan
Yamanaka Tatsuru Pediatrics
Sapporo
Hokkaido
Japan
Matsuda Pediatrics Clinic
Kuwana
Mie-ken
Japan
Kawasaki Medical School, Department of Pediatrics
Kurashiki
Okayama-ken
Japan
Momotaro Clinic
Okayama
Okayama-ken
Japan
Hug Hug Kids Clinic
Toyonaka
Osaka
Japan
Shibuya Clinic
Kumagaya
Saitama
Japan
FG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
FG000161 subjects
FG001160 subjects
Vaccinated Dose 1
FG000159 subjects
FG001158 subjects
Vaccinated Dose 2
FG000147 subjects
FG001157 subjects
Vaccinated Dose 3
FG000133 subjects
FG001155 subjects
COMPLETED
FG000133 subjects
FG001153 subjects
NOT COMPLETED
FG00028 subjects
FG0017 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
FG0015 subjects
Randomized, Not Vaccinated
FG0002 subjects
FG0012 subjects
Other
FG00022 subjects
FG0010 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000133 subjects
FG001153 subjects
COMPLETED
FG000122 subjects
FG001149 subjects
NOT COMPLETED
FG00011 subjects
FG0014 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0012 subjects
Withdrawal by Subject
FG0004 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000122 subjects
FG001149 subjects
COMPLETED
FG000122 subjects
FG001148 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
After Toddler Dose
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001148 subjects
COMPLETED
FG0000 subjects
FG001147 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
BG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000161
BG001160
BG002321
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0003.8± 0.91
BG0013.9± 0.94
BG0023.9± 0.93
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00080
BG00182
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
OG000132
OG001149
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG000100.0(97.2 to 100.0)
OG001100.0(97.6 to 100.0)
Tetanus
Title
Measurements
OG000
Primary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Primary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
1 month after the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Primary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Units
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Secondary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
1 month after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Participants
Secondary
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
Pre-toddler dose, 1 month after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Units
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the catch-up dose 3
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the catch-up dose 3
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after Dose 1 of the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after Dose 2 of the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after Dose 3 of the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.
Posted
Number
Percentage of participants
Within 7 days after Catch-up Dose 1
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.
Posted
Number
Percentage of participants
Within 7 days after Catch-up Dose 2
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.
Posted
Number
Percentage of participants
Within 7 days after Catch-up Dose 3
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after Dose 1 of the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after Dose 2 of the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after Dose 3 of the infant series
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
Posted
Number
Percentage of participants
Within 7 days after the toddler dose
ID
Title
Description
OG000
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
Posted
Number
Percentage of participants
Within 7 days after Catch-up Dose 1
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
Posted
Number
Percentage of participants
Within 7 days after Catch-up Dose 2
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
Posted
Number
Percentage of participants
Within 7 days after Catch-up Dose 3
ID
Title
Description
OG000
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
Time Frame
AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Description
Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
7vPnC + DTaP - Infant Series
Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
3
159
123
159
EG001
DTaP (Catch-up 7vPnC)- Infant Series
Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
7
158
126
158
EG002
7vPnC + DTaP - After the Infant Series
Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
10
159
20
159
EG003
DTaP (Catch-up 7vPnC) - After the Infant Series
Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
7
158
129
158
EG004
7vPnC + DTaP - Toddler Dose
Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
0
122
72
122
EG005
DTaP (Catch-up 7vPnC) - Toddler Dose
Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
4
149
96
149
EG006
DTaP (Catch-up 7vPnC) - After the Toddler Dose
Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
1
149
85
149
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Inguinal hernia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG0030 affected158 at risk
EG0040 affected122 at risk
EG0050 affected149 at risk
EG0060 affected149 at risk
Intussusception
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0021 affected159 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0021 affected159 at risk
EG003
Respiratory syncytial virus bronchitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0022 affected159 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Gastroenteritis adenovirus
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Otitis media
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0024 affected159 at risk
EG003
Infantile asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Kawasaki's disease
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0022 affected159 at risk
EG0032 affected158 at risk
EG004
Conjunctivitis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0006 affected159 at risk
EG00114 affected158 at risk
EG0020 affected159 at risk
EG003
Eye discharge
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Keratitis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0008 affected159 at risk
EG0018 affected158 at risk
EG0020 affected159 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0007 affected159 at risk
EG0019 affected158 at risk
EG0021 affected159 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Vaccination site erythema
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0005 affected159 at risk
EG00110 affected158 at risk
EG0020 affected159 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0005 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Vaccination site induration
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0014 affected158 at risk
EG0020 affected159 at risk
EG003
Injection site induration
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Vaccination site swelling
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Application site erythema
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Food allergy
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0011 affected158 at risk
EG0026 affected159 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Milk allergy
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0021 affected159 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG00049 affected159 at risk
EG00159 affected158 at risk
EG0021 affected159 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG00035 affected159 at risk
EG00122 affected158 at risk
EG0025 affected159 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG00019 affected159 at risk
EG00112 affected158 at risk
EG0020 affected159 at risk
EG003
Influenza
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG00016 affected159 at risk
EG00112 affected158 at risk
EG0020 affected159 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG00010 affected159 at risk
EG00111 affected158 at risk
EG0020 affected159 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0006 affected159 at risk
EG00113 affected158 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0007 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Varicella
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0005 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Impetigo
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0015 affected158 at risk
EG0020 affected159 at risk
EG003
Otitis media
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0005 affected159 at risk
EG0012 affected158 at risk
EG0020 affected159 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0015 affected158 at risk
EG0020 affected159 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0005 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0015 affected158 at risk
EG0020 affected159 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0015 affected158 at risk
EG0020 affected159 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0012 affected158 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0012 affected158 at risk
EG0020 affected159 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Paronychia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Respiratory syncytial virus bronchitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Mucocutaneous candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Rotavirus infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Staphylococcal scalded skin syndrome
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Vaccination site infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Viral infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Viral rash
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0012 affected158 at risk
EG0020 affected159 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Lactose intolerance
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0021 affected159 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG00026 affected159 at risk
EG00122 affected158 at risk
EG0022 affected159 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG00016 affected159 at risk
EG00113 affected158 at risk
EG0021 affected159 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0006 affected159 at risk
EG0018 affected158 at risk
EG0021 affected159 at risk
EG003
Asteatosis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0005 affected159 at risk
EG0014 affected158 at risk
EG0020 affected159 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0016 affected158 at risk
EG0021 affected159 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0004 affected159 at risk
EG0010 affected158 at risk
EG0023 affected159 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0013 affected158 at risk
EG0020 affected159 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0011 affected158 at risk
EG0021 affected159 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0011 affected158 at risk
EG0020 affected159 at risk
EG003
Wolff-Parkinson-White syndrome
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Infantile asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Rhinitis perennial
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0021 affected159 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Allergy to animal
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Herpangina
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Localised infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Otitis media bacterial
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Generalised erythema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Candida nappy rash
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis adenovirus
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected159 at risk
EG0010 affected158 at risk
EG0020 affected159 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00087 affected152 at risk
EG00122 affected152 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00091 affected142 at risk
EG00159 affected150 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG00065 affected123 at risk
EG00144 affected144 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00080 affected152 at risk
EG00119 affected151 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00083 affected142 at risk
EG00150 affected150 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG00057 affected123 at risk
EG00140 affected143 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00022 affected148 at risk
EG0013 affected152 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00043 affected134 at risk
EG00110 affected147 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG00024 affected120 at risk
EG0018 affected139 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG0000 affected148 at risk
EG0010 affected151 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0000 affected133 at risk
EG0010 affected147 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG0000 affected118 at risk
EG0010 affected138 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00060 affected149 at risk
EG00112 affected153 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00071 affected137 at risk
EG00145 affected150 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG00055 affected124 at risk
EG00128 affected144 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00057 affected149 at risk
EG00112 affected153 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00068 affected137 at risk
EG00143 affected150 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG00053 affected124 at risk
EG00128 affected144 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00015 affected148 at risk
EG0010 affected151 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00032 affected134 at risk
EG00110 affected148 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG00014 affected119 at risk
EG0013 affected139 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG0000 affected148 at risk
EG0010 affected151 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0000 affected133 at risk
EG0010 affected147 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG0000 affected118 at risk
EG0010 affected138 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG00018 affected148 at risk
EG0011 affected151 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00010 affected133 at risk
EG0016 affected147 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG0006 affected119 at risk
EG0015 affected138 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
EG0000 affected148 at risk
EG0010 affected151 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0000 affected133 at risk
EG0010 affected147 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3 / After Toddler Dose 3
EG0000 affected118 at risk
EG0010 affected138 at risk
EG0020 affected0 at risk
EG003
Fever ≥37.5°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG00028 affected149 at risk
EG00124 affected152 at risk
EG0020 affected0 at risk
EG003
Fever ≥37.5°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00035 affected138 at risk
EG00123 affected149 at risk
EG0020 affected0 at risk
EG003
Fever ≥37.5°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00023 affected120 at risk
EG00121 affected141 at risk
EG0020 affected0 at risk
EG003
Fever>39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG0003 affected148 at risk
EG0013 affected135 at risk
EG0020 affected0 at risk
EG003
Fever>39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0003 affected135 at risk
EG0010 affected147 at risk
EG0020 affected0 at risk
EG003
Fever>39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0002 affected118 at risk
EG0011 affected138 at risk
EG0020 affected0 at risk
EG003
Fever >40.0°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG0000 affected148 at risk
EG0010 affected151 at risk
EG0020 affected0 at risk
EG003
Fever >40.0°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0000 affected133 at risk
EG0011 affected147 at risk
EG0020 affected0 at risk
EG003
Fever >40.0°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0000 affected118 at risk
EG0010 affected138 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG00013 affected148 at risk
EG00112 affected151 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00016 affected135 at risk
EG0018 affected147 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00010 affected119 at risk
EG0019 affected138 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG00023 affected151 at risk
EG00114 affected151 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00026 affected134 at risk
EG00118 affected149 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00012 affected118 at risk
EG00110 affected139 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG00048 affected150 at risk
EG00139 affected153 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00026 affected136 at risk
EG00119 affected148 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00019 affected119 at risk
EG00126 affected141 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG00025 affected151 at risk
EG00123 affected151 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG00024 affected140 at risk
EG00123 affected151 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0008 affected120 at risk
EG00120 affected140 at risk
EG0020 affected0 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG0002 affected148 at risk
EG0011 affected151 at risk
EG0020 affected0 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0004 affected133 at risk
EG0010 affected147 at risk
EG0020 affected0 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0002 affected119 at risk
EG0010 affected138 at risk
EG0020 affected0 at risk
EG003
Use of antipyretic medication to treat symptoms
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
EG0002 affected148 at risk
EG0012 affected151 at risk
EG0020 affected0 at risk
EG003
Use of antipyretic medication to treat symptoms
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2 / After Infant Series Dose 2
EG0003 affected134 at risk
EG0013 affected147 at risk
EG0020 affected0 at risk
EG003
Use of antipyretic medication to treat symptoms
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0002 affected119 at risk
EG0013 affected138 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D022681
Diphtheria-Tetanus-acellular Pertussis Vaccines
Ancestor Terms
ID
Term
D010567
Pertussis Vaccine
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D004168
Diphtheria Toxoid
D014121
Toxoids
D013745
Tetanus Toxoid
D017778
Vaccines, Combined
D022282
Vaccines, Acellular
D022223
Vaccines, Subunit
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
Other
FG0002 subjects
FG0011 subjects
162
Male
BG00081
BG00178
BG002159
100.0
(97.2 to 100.0)
OG001100.0(97.6 to 100.0)
Pertussis toxoid (PT)
Title
Measurements
OG000100.0(97.2 to 100.0)
OG001100.0(97.6 to 100.0)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG000100.0(97.2 to 100.0)
OG001100.0(97.6 to 100.0)
Units
Counts
Participants
OG000132
OG001149
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG0001.38(1.27 to 1.49)
OG0010.99(0.91 to 1.09)
Tetanus
Title
Measurements
OG0001.91(1.69 to 2.16)
OG0012.05(1.83 to 2.29)
Units
Counts
Participants
OG000132
OG001149
Title
Denominators
Categories
Pertussis toxoid (PT)
Title
Measurements
OG00076.79(70.81 to 83.28)
OG00183.56(77.54 to 90.05)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG00072.89(65.80 to 80.74)
OG00177.85(71.01 to 85.35)
Counts
Participants
OG000132
Title
Denominators
Categories
4
Title
Measurements
OG000100.0(97.2 to 100.0)
6B
Title
Measurements
OG00099.2(95.9 to 100.0)
9V
Title
Measurements
OG000100.0(97.2 to 100.0)
14
Title
Measurements
OG00099.2(95.9 to 100.0)
18C
Title
Measurements
OG00099.2(95.8 to 100.0)
19F
Title
Measurements
OG00097.7(93.5 to 99.5)
23F
Title
Measurements
OG00098.5(94.6 to 99.8)
Participants
OG000132
Title
Denominators
Categories
4
Title
Measurements
OG00011.82(10.50 to 13.31)
6B
Title
Measurements
OG0004.23(3.61 to 4.97)
9V
Title
Measurements
OG0005.96(5.37 to 6.62)
14
Title
Measurements
OG00016.61(14.66 to 18.81)
18C
Title
Measurements
OG0005.48(4.76 to 6.31)
19F
Title
Measurements
OG0008.85(7.54 to 10.40)
23F
Title
Measurements
OG0004.17(3.54 to 4.91)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
OG000121
OG001146
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG000100.0(97.0 to 100.0)
OG001100.0(97.5 to 100.0)
Tetanus
Title
Measurements
OG000100.0(97.0 to 100.0)
OG001100.0(97.5 to 100.0)
Pertussis toxoid (PT)
Title
Measurements
OG000100.0(97.0 to 100.0)
OG001100.0(97.5 to 100.0)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG000100.0(97.0 to 100.0)
OG001100.0(97.5 to 100.0)
Units
Counts
Participants
OG000121
OG001146
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG0002.56(2.35 to 2.78)
OG0012.14(1.94 to 2.35)
Tetanus
Title
Measurements
OG0002.53(2.26 to 2.82)
OG0013.04(2.74 to 3.38)
Units
Counts
Participants
OG000121
OG001146
Title
Denominators
Categories
PT
Title
Measurements
OG000106.54(96.10 to 118.12)
OG001130.62(119.60 to 142.65)
FHA
Title
Measurements
OG000120.99(109.75 to 133.39)
OG001145.38(132.41 to 159.63)
Participants
OG000121
Title
Denominators
Categories
4
Title
Measurements
OG000100.0(97.0 to 100.0)
6B
Title
Measurements
OG000100.0(97.0 to 100.0)
9V
Title
Measurements
OG000100.0(97.0 to 100.0)
14
Title
Measurements
OG000100.0(97.0 to 100.0)
18C
Title
Measurements
OG00099.2(95.5 to 100.0)
19F
Title
Measurements
OG00099.2(95.5 to 100.0)
23F
Title
Measurements
OG000100.0(97.0 to 100.0)
OG000121
Title
Denominators
Categories
4
Title
Measurements
OG00012.15(10.35 to 14.26)
6B
Title
Measurements
OG00010.66(8.96 to 12.68)
9V
Title
Measurements
OG0006.43(5.57 to 7.42)
14
Title
Measurements
OG00015.83(13.81 to 18.14)
18C
Title
Measurements
OG0006.53(5.49 to 7.76)
19F
Title
Measurements
OG0009.70(8.15 to 11.56)
23F
Title
Measurements
OG00010.17(8.58 to 12.07)
Counts
Participants
OG000121
Title
Denominators
Categories
4
Title
Measurements
OG0006.74(5.75 to 7.90)
6B
Title
Measurements
OG0005.89(5.09 to 6.81)
9V
Title
Measurements
OG0004.34(3.81 to 4.93)
14
Title
Measurements
OG0003.63(3.22 to 4.09)
18C
Title
Measurements
OG0006.90(6.06 to 7.85)
19F
Title
Measurements
OG0006.37(5.35 to 7.59)
23F
Title
Measurements
OG0008.10(7.01 to 9.35)
Participants
OG000148
Title
Denominators
Categories
4
Title
Measurements
OG000100.0(97.5 to 100.0)
6B
Title
Measurements
OG00099.3(96.3 to 100.0)
9V
Title
Measurements
OG000100.0(97.5 to 100.0)
14
Title
Measurements
OG000100.0(97.5 to 100.0)
18C
Title
Measurements
OG00099.3(96.3 to 100.0)
19F
Title
Measurements
OG000100.0(97.5 to 100.0)
23F
Title
Measurements
OG00099.3(96.3 to 100.0)
Participants
OG000148
Title
Denominators
Categories
4
Title
Measurements
OG0006.63(5.91 to 7.44)
6B
Title
Measurements
OG0004.30(3.75 to 4.93)
9V
Title
Measurements
OG0003.48(3.12 to 3.89)
14
Title
Measurements
OG00011.55(10.30 to 12.95)
18C
Title
Measurements
OG0003.10(2.69 to 3.57)
19F
Title
Measurements
OG0005.16(4.45 to 5.99)
23F
Title
Measurements
OG0004.41(3.78 to 5.14)
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
OG000152
OG001154
Title
Denominators
Categories
Erythema-Any (n= 152, 152)
Title
Measurements
OG00057.2
OG00114.5
Erythema-Mild (n= 152, 151)
Title
Measurements
OG00052.6
OG00112.6
Erythema-Moderate (n= 148, 152)
Title
Measurements
OG00014.9
OG0012.0
Erythema-Severe (n= 148, 151)
Title
Measurements
OG0000.0
OG0010.0
Induration-Any (n= 149, 153)
Title
Measurements
OG00040.3
OG0017.8
Induration-Mild (n= 149, 153)
Title
Measurements
OG00038.3
OG0017.8
Induration-Moderate (n= 148, 151)
Title
Measurements
OG00010.1
OG0010.0
Induration-Severe (n= 148, 151)
Title
Measurements
OG0000.0
OG0010.0
Tenderness-Any (n= 148, 151)
Title
Measurements
OG00012.2
OG0010.7
Tenderness-Significant (n= 148, 151)
Title
Measurements
OG0000.0
OG0010.0
Any local reaction (n= 152, 154)
Title
Measurements
OG00066.4
OG00115.6
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
OG000143
OG001151
Title
Denominators
Categories
Erythema-Any (n= 142, 150)
Title
Measurements
OG00064.1
OG00139.3
Erythema-Mild (n= 142, 150)
Title
Measurements
OG00058.5
OG00133.3
Erythema-Moderate (n= 134, 147)
Title
Measurements
OG00032.1
OG0016.8
Erythema-Severe (n= 133, 147)
Title
Measurements
OG0000.0
OG0010.0
Induration-Any (n= 137, 150)
Title
Measurements
OG00051.8
OG00130.0
Induration-Mild (n= 137, 150)
Title
Measurements
OG00049.6
OG00128.7
Induration-Moderate (n= 134, 148)
Title
Measurements
OG00023.9
OG0016.8
Induration-Severe (n= 133, 147)
Title
Measurements
OG0000.0
OG0010.0
Tenderness-Any (n= 133, 147)
Title
Measurements
OG0007.5
OG0014.1
Tenderness-Significant (n= 133, 147)
Title
Measurements
OG0000.0
OG0010.0
Any local reaction (n= 143, 151)
Title
Measurements
OG00069.2
OG00145.0
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
OG000126
OG001145
Title
Denominators
Categories
Erythema-Any (n= 123, 144)
Title
Measurements
OG00052.8
OG00130.6
Erythema-Mild (n= 123, 143)
Title
Measurements
OG00046.3
OG00128.0
Erythema-Moderate (n= 120, 139)
Title
Measurements
OG00020.0
OG0015.8
Erythema-Severe (n= 118, 138)
Title
Measurements
OG0000.0
OG0010.0
Induration-Any (n= 124, 144)
Title
Measurements
OG00044.4
OG00119.4
Induration-Mild (n= 124, 144)
Title
Measurements
OG00042.7
OG00119.4
Induration-Moderate (n= 119, 139)
Title
Measurements
OG00011.8
OG0012.2
Induration-Severe (n= 118, 138)
Title
Measurements
OG0000.0
OG0010.0
Tenderness-Any (n= 119, 138)
Title
Measurements
OG0005.0
OG0013.6
Tenderness-Significant (n= 118, 138)
Title
Measurements
OG0000.0
OG0010.0
Any local reaction (n= 126, 145)
Title
Measurements
OG00061.1
OG00133.1
OG001
DTaP (Catch-up 7vPnC)
Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Units
Counts
Participants
OG000110
OG001138
Title
Denominators
Categories
Erythema-Any (n= 108, 137)
Title
Measurements
OG00051.9
OG00132.1
Erythema-Mild (n= 106, 137)
Title
Measurements
OG00048.1
OG00128.5
Erythema-Moderate (n= 102, 134)
Title
Measurements
OG00023.5
OG0017.5
Erythema-Severe (n= 98, 133)
Title
Measurements
OG0000.0
OG0010.0
Induration-Any (n= 108, 137)
Title
Measurements
OG00042.6
OG00123.4
Induration-Mild (n= 108, 137)
Title
Measurements
OG00040.7
OG00119.7
Induration-Moderate (n= 99, 133)
Title
Measurements
OG00016.2
OG0016.8
Induration-Severe (n= 98, 133)
Title
Measurements
OG0000.0
OG0010.0
Tenderness-Any (n= 99, 136)
Title
Measurements
OG00011.1
OG0014.4
Tenderness-Significant (n= 98, 133)
Title
Measurements
OG0000.0
OG0010.0
Any local reaction (n= 110, 138)
Title
Measurements
OG00056.4
OG00139.1
Units
Counts
Participants
OG000141
Title
Denominators
Categories
Erythema-Any (n= 139)
Title
Measurements
OG00051.8
Erythema-Mild (n= 139)
Title
Measurements
OG00045.3
Erythema-Moderate (n= 136)
Title
Measurements
OG00010.3
Erythema-Severe (n= 135)
Title
Measurements
OG0000.0
Induration-Any (n= 138)
Title
Measurements
OG00034.8
Induration-Mild (n= 138)
Title
Measurements
OG00032.6
Induration-Moderate (n= 135)
Title
Measurements
OG0008.1
Induration-Severe (n= 135)
Title
Measurements
OG0000.0
Tenderness-Any (n= 136)
Title
Measurements
OG0008.1
Tenderness-Significant (n= 135)
Title
Measurements
OG0000.0
Any local reaction (n= 141)
Title
Measurements
OG00054.6
Units
Counts
Participants
OG000145
Title
Denominators
Categories
Erythema-Any (n= 144)
Title
Measurements
OG00050.7
Erythema-Mild (n= 144)
Title
Measurements
OG00045.1
Erythema-Moderate (n= 140)
Title
Measurements
OG00013.6
Erythema-Severe (n= 138)
Title
Measurements
OG0000.0
Induration-Any (n= 144)
Title
Measurements
OG00032.6
Induration-Mild (n= 143)
Title
Measurements
OG00030.1
Induration-Moderate (n= 140)
Title
Measurements
OG00015.0
Induration-Severe (n= 138)
Title
Measurements
OG0000.0
Tenderness-Any (n= 139)
Title
Measurements
OG0005.0
Tenderness-Significant (n= 138)
Title
Measurements
OG0000.0
Any local reaction (n= 145)
Title
Measurements
OG00055.2
Units
Counts
Participants
OG000137
Title
Denominators
Categories
Erythema-Any (n= 134)
Title
Measurements
OG00032.1
Erythema-Mild (n= 133)
Title
Measurements
OG00027.1
Erythema-Moderate (n= 131)
Title
Measurements
OG0009.9
Erythema-Severe (n= 130)
Title
Measurements
OG0000.0
Induration-Any (n= 134)
Title
Measurements
OG00027.6
Induration-Mild (n= 133)
Title
Measurements
OG00024.8
Induration-Moderate (n= 131)
Title
Measurements
OG0009.9
Induration-Severe (n= 130)
Title
Measurements
OG0000.0
Tenderness-Any (n= 132)
Title
Measurements
OG0006.8
Tenderness-Significant (n= 130)
Title
Measurements
OG0000.0
Any local reaction (n= 137)
Title
Measurements
OG00040.9
Units
Counts
Participants
OG000154
OG001153
Title
Denominators
Categories
Fever >=37.5 but =<39 degrees C(n=149,152)
Title
Measurements
OG00018.8
OG00115.8
Fever >39 but =<40.0 degrees C(n=148,151)
Title
Measurements
OG0002.0
OG0012.0
Fever >40 degrees C(n=148,151)
Title
Measurements
OG0000.0
OG0010.0
Decreased appetite(n=148,151)
Title
Measurements
OG0008.8
OG0017.9
Irritability(n=151,151)
Title
Measurements
OG00015.2
OG0019.3
Increased sleep(n=150,153)
Title
Measurements
OG00032.0
OG00125.5
Decreased sleep(n=151,151)
Title
Measurements
OG00016.6
OG00115.2
Hives (urticaria)(n=148,151)
Title
Measurements
OG0001.4
OG0010.7
Antipyretic medication to treat symptom(n=148,151)
Title
Measurements
OG0001.4
OG0011.3
Any systemic event(n=154,153)
Title
Measurements
OG00057.8
OG00148.4
Units
Counts
Participants
OG000142
OG001153
Title
Denominators
Categories
Fever >=37.5 but =<39 degrees C(n=138,149)
Title
Measurements
OG00025.4
OG00115.4
Fever >39 but =<40.0 degrees C(n=135,147)
Title
Measurements
OG0002.2
OG0010.0
Fever >40 degrees C(n=133,147)
Title
Measurements
OG0000.0
OG0010.7
Decreased appetite(n=135,147)
Title
Measurements
OG00011.9
OG0015.4
Irritability(n=134,149)
Title
Measurements
OG00019.4
OG00112.1
Increased sleep(n=136,148)
Title
Measurements
OG00019.1
OG00112.8
Decreased sleep(n=140,151)
Title
Measurements
OG00017.1
OG00115.2
Hives (urticaria)(n=133,147)
Title
Measurements
OG0003.0
OG0010.0
Antipyretic medication to treat symptom(n=134,147)
Title
Measurements
OG0002.2
OG0012.0
Any systemic event(n=142,153)
Title
Measurements
OG00053.5
OG00138.6
Units
Counts
Participants
OG000122
OG001143
Title
Denominators
Categories
Fever >=37.5 but =<39 degrees C(n=120,141)
Title
Measurements
OG00019.2
OG00114.9
Fever >39 but =<40.0 degrees C(n=118,138)
Title
Measurements
OG0001.7
OG0010.7
Fever >40 degrees C(n=118,138)
Title
Measurements
OG0000.0
OG0010.0
Decreased appetite(n=119,138)
Title
Measurements
OG0008.4
OG0016.5
Irritability(n=118,139)
Title
Measurements
OG00010.2
OG0017.2
Increased sleep(n=119,141)
Title
Measurements
OG00016.0
OG00118.4
Decreased sleep(n=120,140)
Title
Measurements
OG0006.7
OG00114.3
Hives (urticaria)(n=119,138)
Title
Measurements
OG0001.7
OG0010.0
Antipyretic medication to treat symptom(n=119,138)