diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
7-valent pneumococcal conjugate vaccine (7vPnC)
DTaP
DTaP
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01200368
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1851056
Secondary IDs
ID
Type
Description
Link
B1851056
6096A1-3024
Other Identifier
Alias Study Number
Brief Title
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Official Title
A Phase 3, Randomized, Active-controlled, Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2018
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
Sep 24, 2010Actual
Primary Completion Date
Nov 30, 2011Actual
Completion Date
Nov 30, 2011Actual
First Submitted Date
Aug 31, 2010
First Submission Date that Met QC Criteria
Sep 10, 2010
First Posted Date
Sep 13, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 12, 2012
Results First Submitted that Met QC Criteria
Sep 12, 2012
Results First Posted Date
Oct 12, 2012Estimated
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
Nov 30, 2018
Last Update Posted Date
Dec 19, 2018Actual
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 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.
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% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
1 month after the infant series
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (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
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
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
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects between 3 to 6 months of age at the enrollment.
Available for the entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgement 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).
Infant who is a direct descendant (child, grandchild) of the study site personnel.
Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC 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
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
Biological
0.5 mL per dose, 4 doses
1
7-valent pneumococcal conjugate vaccine (7vPnC)
Biological
0.5 mL per dose, 4 doses
2
DTaP
Biological
0.5 mL per dose, 4 doses
2
DTaP
Biological
0.5 mL per dose, 4 doses
3
1 month after the infant series
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 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
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 GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
1 month after the toddler dose
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMC was 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
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
1 month after the toddler dose
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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 7 days after the toddler dose
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 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 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 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 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 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 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
Isumi
Chiba
299-4503
Japan
Matsuyama Red Cross Hospital
Matsuyama
Ehime
790-8524
Japan
Fukazawa Pediatric Clinic
Higashi-ku, Fukuoka-city
Fukuoka
813-0036
Japan
National Hospital Organization Fukuyama Medical Center
Fukuyama
Hiroshima
720-8520
Japan
National Hospital Organization Kure Medical Center
Kure
Hiroshima
737-0023
Japan
Nakata pediatric clinic
Sapporo
Hokkaido
003-0023
Japan
Watanabe Pediatric Allergy Clinic
Sapporo
Hokkaido
006-0831
Japan
Furuta Children's Clinic
Sapporo
Hokkaido
063-0831
Japan
Motomachi pediatric clinic
Sapporo
Hokkaido
065-0024
Japan
Tenshi Hospital
Sapporo
Hokkaido
065-8611
Japan
Yoshimoto Pediatrist Clinic
Kikuchi-gun
Kumamoto
869-1102
Japan
Shiroko Clinic
Suzuka
Mie-ken
510-0235
Japan
National Mie Hospital
Tsu
Mie-ken
514-0125
Japan
National hospital Organization Mie Chuou Medical Center
Tsu
Mie-ken
514-1101
Japan
Children's Enomoto Clinic
Kumagaya
Saitama
360-0018
Japan
Shibuya Clinic
Kumagaya
Saitama
360-0812
Japan
Sakiyama Children's Clinic
Fuchū
Tokyo
183-0042
Japan
Okawa Children and Family Clinic
ÅŒta-ku
Tokyo
146-0095
Japan
Seijo Sasamoto Pediatric And Allergy Clinic
Setagaya-ku
Tokyo
157-0066
Japan
National Center for Child Health and Development
Setagaya-ku
Tokyo
157-8535
Japan
Miyata Pediatric Clinic
Tachikawa-shi
Tokyo
190-0002
Japan
Maehara Pediatric Clinic
Tama
Tokyo
206-0011
Japan
Childrens Clinic of Kose
Kofu
Yamanashi
400-0853
Japan
Medical Corporation Bunpoukai Amemiya Clinic
Koushu-shi
Yamanashi
404-0046
Japan
Medical Corporation Seijinkai Takei Clinic
Tsuru-shi
Yamanashi
402-0025
Japan
National Hospital Organization Fukuoka National Hospital
Fukuoka
811-1394
Japan
Harada Clinic
Fukuoka
816-0094
Japan
Hattori Pediatric Clinic
Kumamoto
860-0812
Japan
Medical Corporation Seiaikai Seguchi Pediatric Clinic
Kumamoto
860-0834
Japan
Medical Corporation Oukakai Sakuranbo Kodomo Clinic
Kumamoto
862-0924
Japan
Momotaro Clinic
Okayama
701-0205
Japan
FG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
FG002
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.
FG000183 subjects
FG001184 subjects
FG002184 subjects
Vaccinated Dose 1
FG000183 subjects
FG001183 subjects
FG002183 subjects
Vaccinated Dose 2
FG000183 subjects
FG001182 subjects
FG002183 subjects
Vaccinated Dose 3
FG000181 subjects
FG001178 subjects
FG002182 subjects
COMPLETED
FG000180 subjects
FG001178 subjects
FG002178 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0026 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0023 subjects
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0022 subjects
Did not meet entrance criteria
FG0000 subjects
FG0011 subjects
FG0020 subjects
Randomized, not vaccinated
FG0000 subjects
FG0011 subjects
FG0021 subjects
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000180 subjects
FG001178 subjects
FG002178 subjects
COMPLETED
FG000162 subjects
FG001162 subjects
FG002169 subjects
NOT COMPLETED
FG00018 subjects
FG00116 subjects
FG0029 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0016 subjects
FG0023 subjects
Withdrawal by Subject
FG000
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000162 subjects
FG001162 subjects
FG002169 subjects
COMPLETED
FG000162 subjects
FG001159 subjects
FG002168 subjects
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0021 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
FG0021 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
BG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
BG002
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000183
BG001184
BG002184
BG003551
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
BG0004.1± 0.97
BG0014.1± 0.97
BG0024.2± 0.96
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00087
BG00191
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 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% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
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 and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Participants
OG000177
OG001176
Title
Denominators
Categories
4
Title
Measurements
OG000100.0(97.9 to 100.0)
OG001100.0(97.9 to 100.0)
6B
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).
Percent difference
0.0
2-Sided
95
-2.2
2.1
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (>) -0.10.
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (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 and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
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 and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
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 and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
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 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
Secondary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Predefined antibody level was 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 population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
GMC was measured in IU/mL and corresponding 2-sided 95% 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 and determinate assay result for the proposed analysis, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
GMC was 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 expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population 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
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population 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
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population 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
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
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). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population 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
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
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 reaction. '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 infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC 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 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 reaction. '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 infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC 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 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 reaction. '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 infant series
ID
Title
Description
OG000
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC 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 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 reaction. '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
13vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC 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 13vPnC dose.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Time Frame
AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified 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
13vPnC + DTaP - Infant Series
Participants who received 3 single 0.5 mL doses of 13vPnC 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.
5
183
147
183
EG001
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.
8
183
160
183
EG002
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.
10
183
155
183
EG003
13vPnC + DTaP - After the Infant Series
Participants who received 3 single 0.5 mL doses of 13vPnC 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.
13
183
20
183
EG004
7vPnC + DTaP - After the Infant Series
Participants who received 3 single 0.5 mL doses of 13vPnC 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.
15
183
27
183
EG005
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.
10
183
147
183
EG006
13vPnC + DTaP - Toddler Dose
Participants who received a single 0.5 mL dose of 13vPnC 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
162
104
162
EG007
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.
4
162
99
162
EG008
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.
2
169
112
169
EG009
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.
2
169
105
169
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dacryostenosis congenital
Congenital, familial and genetic disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG0030 affected183 at risk
EG004
Bronchiolitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0022 affected183 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0023 affected183 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0021 affected183 at risk
EG003
Neuritis cranial
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Kawasaki's disease
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0022 affected183 at risk
EG003
Deafness bilateral
Ear and labyrinth disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Herpangina
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Mycoplasma infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Otitis media
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Parotitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Rotavirus infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 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 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG0033 affected183 at risk
EG004
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Blepharitis
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0007 affected183 at risk
EG00111 affected183 at risk
EG00220 affected183 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Eye discharge
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0007 affected183 at risk
EG0015 affected183 at risk
EG0023 affected183 at risk
EG003
Keratitis
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0022 affected183 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Acetonaemic vomiting
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0014 affected183 at risk
EG0023 affected183 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG00010 affected183 at risk
EG0019 affected183 at risk
EG0025 affected183 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Application site erythema
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Injection site dermatitis
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Injection site erythema
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0014 affected183 at risk
EG0020 affected183 at risk
EG003
Injection site induration
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0013 affected183 at risk
EG0020 affected183 at risk
EG003
Injection site swelling
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0004 affected183 at risk
EG0015 affected183 at risk
EG0026 affected183 at risk
EG003
Vaccination site induration
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0013 affected183 at risk
EG0020 affected183 at risk
EG003
Vaccination site erythema
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Vaccination site swelling
General disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Food allergy
Immune system disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0012 affected183 at risk
EG0022 affected183 at risk
EG003
Milk allergy
Immune system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0011 affected183 at risk
EG0021 affected183 at risk
EG003
Adenoviral conjunctivitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0021 affected183 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Anal fungal infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0012 affected183 at risk
EG0025 affected183 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG00024 affected183 at risk
EG00128 affected183 at risk
EG00226 affected183 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0012 affected183 at risk
EG0021 affected183 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0021 affected183 at risk
EG003
Conjunctivitis infective
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0003 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0024 affected183 at risk
EG003
Echo virus infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Erythema infectiosum
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG00010 affected183 at risk
EG00117 affected183 at risk
EG00219 affected183 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG00028 affected183 at risk
EG00124 affected183 at risk
EG00231 affected183 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0022 affected183 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0007 affected183 at risk
EG0019 affected183 at risk
EG0027 affected183 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0021 affected183 at risk
EG003
Gianotti-Crosti syndrome
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Herpangina
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Impetigo
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0003 affected183 at risk
EG0013 affected183 at risk
EG0022 affected183 at risk
EG003
Influenza
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0003 affected183 at risk
EG0014 affected183 at risk
EG0026 affected183 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG00048 affected183 at risk
EG00158 affected183 at risk
EG00251 affected183 at risk
EG003
Omphalitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0012 affected183 at risk
EG0021 affected183 at risk
EG003
Otitis media
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0008 affected183 at risk
EG0016 affected183 at risk
EG0027 affected183 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0015 affected183 at risk
EG0023 affected183 at risk
EG003
Paronychia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0003 affected183 at risk
EG0013 affected183 at risk
EG0022 affected183 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Pneumococcal bacteraemia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0021 affected183 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Respiratory syncytial virus bronchitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0011 affected183 at risk
EG0022 affected183 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0009 affected183 at risk
EG00114 affected183 at risk
EG0024 affected183 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0013 affected183 at risk
EG0022 affected183 at risk
EG003
Rotavirus infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0010 affected183 at risk
EG0022 affected183 at risk
EG003
Skin candida
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Skin infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0023 affected183 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG00054 affected183 at risk
EG00167 affected183 at risk
EG00265 affected183 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Varicella
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0004 affected183 at risk
EG0018 affected183 at risk
EG0024 affected183 at risk
EG003
Viral infection
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Viral rash
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0003 affected183 at risk
EG0010 affected183 at risk
EG0022 affected183 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Ear injury
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0021 affected183 at risk
EG003
Frostbite
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Body height below normal
Investigations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Lactose intolerance
Metabolism and nutrition disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Neuritis cranial
Nervous system disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Breast swelling
Reproductive system and breast disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Genital labial adhesions
Reproductive system and breast disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Posthitis
Reproductive system and breast disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0006 affected183 at risk
EG0013 affected183 at risk
EG00210 affected183 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Fibrinous bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Infantile asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Pulmonary artery stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0021 affected183 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0005 affected183 at risk
EG0012 affected183 at risk
EG0022 affected183 at risk
EG003
Asteatosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0008 affected183 at risk
EG0017 affected183 at risk
EG0025 affected183 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0004 affected183 at risk
EG0010 affected183 at risk
EG0023 affected183 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0004 affected183 at risk
EG0015 affected183 at risk
EG0025 affected183 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG00016 affected183 at risk
EG00119 affected183 at risk
EG00226 affected183 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0007 affected183 at risk
EG0012 affected183 at risk
EG0025 affected183 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG00024 affected183 at risk
EG00126 affected183 at risk
EG00227 affected183 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0009 affected183 at risk
EG0018 affected183 at risk
EG0024 affected183 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG00012 affected183 at risk
EG0017 affected183 at risk
EG0027 affected183 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0012 affected183 at risk
EG0020 affected183 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Hyperkeratosis palmaris and plantaris
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0002 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0006 affected183 at risk
EG0012 affected183 at risk
EG0025 affected183 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0011 affected183 at risk
EG0020 affected183 at risk
EG003
Scar
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 14.1
Non-systematic Assessment
EG0003 affected183 at risk
EG0015 affected183 at risk
EG0024 affected183 at risk
EG003
Haematoma
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Kawasaki's disease
Vascular disorders
MedDRA 14.1
Non-systematic Assessment
EG0001 affected183 at risk
EG0010 affected183 at risk
EG0021 affected183 at risk
EG003
Redness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG000100 affected171 at risk
EG00196 affected172 at risk
EG00217 affected165 at risk
EG003
Redness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG000104 affected166 at risk
EG001104 affected168 at risk
EG00259 affected161 at risk
EG003
Redness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00090 affected168 at risk
EG00183 affected162 at risk
EG00236 affected156 at risk
EG003
Redness (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00082 affected170 at risk
EG00188 affected172 at risk
EG00217 affected165 at risk
EG003
Redness (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG00093 affected166 at risk
EG00195 affected167 at risk
EG00256 affected161 at risk
EG003
Redness (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00079 affected167 at risk
EG00169 affected160 at risk
EG00234 affected156 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00031 affected164 at risk
EG00130 affected166 at risk
EG0020 affected162 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG00041 affected157 at risk
EG00143 affected159 at risk
EG00213 affected156 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00026 affected152 at risk
EG00134 affected154 at risk
EG0023 affected153 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0000 affected161 at risk
EG0011 affected162 at risk
EG0020 affected162 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG0000 affected157 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG0000 affected149 at risk
EG0010 affected152 at risk
EG0020 affected152 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00069 affected168 at risk
EG00160 affected168 at risk
EG0028 affected164 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG00077 affected160 at risk
EG00187 affected171 at risk
EG00239 affected162 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00072 affected164 at risk
EG00159 affected157 at risk
EG00234 affected159 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00064 affected168 at risk
EG00153 affected168 at risk
EG0028 affected164 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG00071 affected160 at risk
EG00182 affected170 at risk
EG00237 affected162 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00069 affected164 at risk
EG00153 affected156 at risk
EG00232 affected159 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00020 affected162 at risk
EG00121 affected165 at risk
EG0020 affected162 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG00031 affected157 at risk
EG00128 affected157 at risk
EG0029 affected155 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00016 affected150 at risk
EG00123 affected154 at risk
EG0024 affected153 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0000 affected161 at risk
EG0011 affected162 at risk
EG0020 affected162 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG0000 affected157 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG0000 affected149 at risk
EG0010 affected152 at risk
EG0020 affected152 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00022 affected163 at risk
EG00110 affected164 at risk
EG0022 affected162 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG00023 affected159 at risk
EG0017 affected154 at risk
EG0023 affected155 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG00012 affected153 at risk
EG00111 affected155 at risk
EG0024 affected153 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0000 affected161 at risk
EG0010 affected162 at risk
EG0020 affected162 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2
EG0001 affected157 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3
EG0000 affected149 at risk
EG0010 affected152 at risk
EG0021 affected152 at risk
EG003
Fever >=37.5, =<39 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00061 affected168 at risk
EG00157 affected168 at risk
EG00236 affected165 at risk
EG003
Fever >=37.5, =<39 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG00061 affected166 at risk
EG00159 affected161 at risk
EG00234 affected155 at risk
EG003
Fever >=37.5, =<39 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00056 affected162 at risk
EG00149 affected161 at risk
EG00238 affected157 at risk
EG003
Fever >=39, =<40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0021 affected162 at risk
EG003
Fever >=39, =<40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG0003 affected158 at risk
EG0016 affected155 at risk
EG0021 affected154 at risk
EG003
Fever >=39, =<40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0005 affected150 at risk
EG0013 affected152 at risk
EG0025 affected153 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0000 affected161 at risk
EG0010 affected162 at risk
EG0020 affected162 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG0000 affected157 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Fever >40 degrees C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0000 affected149 at risk
EG0011 affected152 at risk
EG0020 affected152 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00021 affected163 at risk
EG00115 affected163 at risk
EG00212 affected165 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG00018 affected158 at risk
EG00123 affected159 at risk
EG00211 affected155 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00015 affected152 at risk
EG00115 affected155 at risk
EG0029 affected154 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00031 affected165 at risk
EG00127 affected164 at risk
EG00220 affected164 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG00029 affected162 at risk
EG00129 affected155 at risk
EG00217 affected156 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00027 affected154 at risk
EG00123 affected156 at risk
EG00218 affected154 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00049 affected170 at risk
EG00144 affected165 at risk
EG00236 affected165 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG00037 affected163 at risk
EG00135 affected158 at risk
EG00237 affected163 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00031 affected151 at risk
EG00132 affected157 at risk
EG00223 affected154 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00030 affected164 at risk
EG00136 affected169 at risk
EG00223 affected167 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG00030 affected161 at risk
EG00119 affected157 at risk
EG00219 affected157 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00028 affected154 at risk
EG00120 affected156 at risk
EG00215 affected153 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0005 affected161 at risk
EG0012 affected162 at risk
EG0020 affected162 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG0004 affected157 at risk
EG0012 affected154 at risk
EG0023 affected154 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0002 affected149 at risk
EG0010 affected152 at risk
EG0022 affected152 at risk
EG003
Use of antipyretic medication to treat symptoms
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0006 affected161 at risk
EG0014 affected162 at risk
EG0021 affected162 at risk
EG003
Use of antipyretic medication to treat symptoms
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG0005 affected160 at risk
EG0017 affected155 at risk
EG0022 affected154 at risk
EG003
Use of antipyretic medication to treat symptoms
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0003 affected150 at risk
EG0015 affected153 at risk
EG0027 affected154 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 14.1
Non-systematic Assessment
EG0000 affected183 at risk
EG0010 affected183 at risk
EG0020 affected183 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
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
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
D022242
Pneumococcal Vaccines
D022541
Streptococcal Vaccines
Browse Leaves
Not provided
Browse Branches
Not provided
10 subjects
FG0018 subjects
FG0024 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other
FG0001 subjects
FG0012 subjects
FG0022 subjects
4.1
± 0.97
91
BG003269
Male
BG00096
BG00193
BG00293
BG003282
97.7
(94.3 to 99.4)
OG00199.4(96.9 to 100.0)
9V
Title
Measurements
OG000100.0(97.9 to 100.0)
OG001100.0(97.9 to 100.0)
14
Title
Measurements
OG000100.0(97.9 to 100.0)
OG001100.0(97.9 to 100.0)
18C
Title
Measurements
OG000100.0(97.9 to 100.0)
OG001100.0(97.9 to 100.0)
19F
Title
Measurements
OG00098.9(96.0 to 99.9)
OG00196.6(92.7 to 98.7)
23F
Title
Measurements
OG00097.7(94.3 to 99.4)
OG00198.3(95.1 to 99.6)
1
Title
Measurements
OG000100.0(97.9 to 100.0)
OG00196.6(92.7 to 98.7)
3
Title
Measurements
OG00099.4(96.9 to 100.0)
OG00196.6(92.7 to 98.7)
5
Title
Measurements
OG00099.4(96.9 to 100.0)
OG00196.6(92.7 to 98.7)
6A
Title
Measurements
OG00098.3(95.1 to 99.6)
OG00196.6(92.7 to 98.7)
7F
Title
Measurements
OG000100.0(97.9 to 100.0)
OG00196.6(92.7 to 98.7)
19A
Title
Measurements
OG000100.0(97.9 to 100.0)
OG00196.6(92.7 to 98.7)
OG000
OG001
Serotype 6B: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
-1.7
2-Sided
95
-5.2
1.1
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 9V: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.1
2.1
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 14: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.1
2.1
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 18C: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.1
2.1
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 19F: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
2.3
2-Sided
95
-1.1
6.3
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 23F: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
-0.6
2-Sided
95
-4.2
2.9
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 1: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
3.4
2-Sided
95
0.9
7.3
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 3: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
2.9
2-Sided
95
-0.2
6.7
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 5: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
2.9
2-Sided
95
-0.2
6.7
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 6A: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
1.7
2-Sided
95
-1.9
5.8
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 7F: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
3.4
2-Sided
95
0.9
7.3
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 19A: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
3.4
2-Sided
95
1.0
7.3
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Participants
OG000177
OG001176
Title
Denominators
Categories
4
Title
Measurements
OG0009.40(8.48 to 10.41)
OG00111.54(10.51 to 12.67)
6B
Title
Measurements
OG0004.50(3.90 to 5.21)
OG0015.71(4.93 to 6.63)
9V
Title
Measurements
OG0005.04(4.52 to 5.62)
OG0016.80(6.15 to 7.52)
14
Title
Measurements
OG00013.86(12.16 to 15.80)
OG00116.79(15.03 to 18.76)
18C
Title
Measurements
OG0005.30(4.75 to 5.91)
OG0017.26(6.53 to 8.08)
19F
Title
Measurements
OG0007.37(6.43 to 8.46)
OG0018.38(7.17 to 9.80)
23F
Title
Measurements
OG0003.64(3.16 to 4.19)
OG0014.53(3.96 to 5.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.81
2-Sided
95
0.71
0.94
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was >0.5.
OG000
OG001
Serotype 6B: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.79
2-Sided
95
0.64
0.97
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 9V: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.74
2-Sided
95
0.64
0.86
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 14: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.83
2-Sided
95
0.70
0.98
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 18C: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.73
2-Sided
95
0.63
0.85
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 19F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.88
2-Sided
95
0.72
1.08
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 23F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.80
2-Sided
95
0.66
0.98
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG002
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
OG000177
OG001176
OG002175
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG00099.4(96.9 to 100.0)
OG00196.6(92.7 to 98.7)
OG002100.0(97.9 to 100.0)
Tetanus
Title
Measurements
OG000100.0(97.9 to 100.0)
OG001100.0(97.9 to 100.0)
OG002100.0(97.9 to 100.0)
Pertussis toxoid (PT)
Title
Measurements
OG00099.4(96.9 to 100.0)
OG00196.6(92.7 to 98.7)
OG002100.0(97.9 to 100.0)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG00099.4(96.9 to 100.0)
OG00196.6(92.7 to 98.7)
OG002100.0(97.9 to 100.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.
Percent difference
-0.6
2-Sided
95
-3.1
1.6
Superiority or Other
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.
Percent difference
0.0
2-Sided
95
-2.1
2.2
Superiority or Other
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.
Percent difference
-0.6
2-Sided
95
-3.1
1.6
Superiority or Other
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.
Percent difference
-0.6
2-Sided
95
-3.1
1.6
Superiority or Other
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Participants
OG000177
OG001176
Title
Denominators
Categories
1
Title
Measurements
OG0008.14(7.23 to 9.18)
OG0014.53(3.96 to 5.18)
3
Title
Measurements
OG0004.90(4.43 to 5.42)
OG0014.53(3.96 to 5.18)
5
Title
Measurements
OG0004.64(4.14 to 5.20)
OG0014.53(3.96 to 5.18)
6A
Title
Measurements
OG0004.71(4.15 to 5.34)
OG0014.53(3.96 to 5.18)
7F
Title
Measurements
OG0008.26(7.45 to 9.17)
OG0014.53(3.96 to 5.18)
19A
Title
Measurements
OG0008.56(7.67 to 9.56)
OG0014.53(3.96 to 5.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.80
2-Sided
95
1.50
2.15
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 3: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.08
2-Sided
95
0.92
1.28
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 5: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.03
2-Sided
95
0.86
1.22
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 6A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.04
2-Sided
95
0.87
1.25
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 7F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.83
2-Sided
95
1.54
2.16
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 19A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.89
2-Sided
95
1.59
2.25
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Participants
OG000158
OG001154
Title
Denominators
Categories
4
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
6B
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
9V
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
14
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
18C
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
19F
Title
Measurements
OG00098.7(95.5 to 99.8)
OG00199.4(96.4 to 100.0)
23F
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
1
Title
Measurements
OG00099.4(96.5 to 100.0)
OG00199.4(96.4 to 100.0)
3
Title
Measurements
OG00099.4(96.5 to 100.0)
OG00199.4(96.4 to 100.0)
5
Title
Measurements
OG000100.0(97.7 to 100.0)
OG00199.4(96.4 to 100.0)
6A
Title
Measurements
OG000100.0(97.7 to 100.0)
OG00199.4(96.4 to 100.0)
7F
Title
Measurements
OG000100.0(97.7 to 100.0)
OG00199.4(96.4 to 100.0)
19A
Title
Measurements
OG000100.0(97.7 to 100.0)
OG00199.4(96.4 to 100.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.4
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 6B: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.4
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 9V: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.4
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 14: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.4
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 18C: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.4
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 19F: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
-0.6
2-Sided
95
-3.9
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 23F: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.
Percent difference
0.0
2-Sided
95
-2.4
2.4
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 1: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
0.0
2-Sided
95
-2.9
3.0
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 3: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
0.0
2-Sided
95
-2.9
3.0
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 5: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
0.6
2-Sided
95
-1.7
3.6
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 6A: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
0.6
2-Sided
95
-1.7
3.6
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 7F: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
0.6
2-Sided
95
-1.7
3.6
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG000
OG001
Serotype 19A: Difference ([13vPnC + DTaP] - [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.
Percent difference
0.6
2-Sided
95
-1.7
3.6
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.
OG001
7vPnC + DTaP
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
Units
Counts
Participants
OG000158
OG001154
Title
Denominators
Categories
4
Title
Measurements
OG00015.34(13.23 to 17.79)
OG00116.35(14.19 to 18.83)
6B
Title
Measurements
OG00017.05(14.47 to 20.08)
OG00113.91(11.93 to 16.21)
9V
Title
Measurements
OG0007.00(6.11 to 8.03)
OG0018.64(7.54 to 9.89)
14
Title
Measurements
OG00019.70(17.69 to 21.93)
OG00120.69(18.25 to 23.47)
18C
Title
Measurements
OG0008.10(6.94 to 9.47)
OG0019.88(8.64 to 11.30)
19F
Title
Measurements
OG00016.73(14.20 to 19.71)
OG0019.55(8.11 to 11.26)
23F
Title
Measurements
OG0008.64(7.46 to 10.01)
OG00110.00(8.61 to 11.62)
1
Title
Measurements
OG00013.96(11.94 to 16.31)
OG0018.64(7.54 to 9.89)
3
Title
Measurements
OG0002.48(2.17 to 2.85)
OG0018.64(7.54 to 9.89)
5
Title
Measurements
OG00011.10(9.83 to 12.53)
OG0018.64(7.54 to 9.89)
6A
Title
Measurements
OG00015.17(13.31 to 17.30)
OG0018.64(7.54 to 9.89)
7F
Title
Measurements
OG00010.90(9.54 to 12.45)
OG0018.64(7.54 to 9.89)
19A
Title
Measurements
OG00016.02(14.07 to 18.25)
OG0018.64(7.54 to 9.89)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 4: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.94
2-Sided
95
0.77
1.15
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 6B: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
1.23
2-Sided
95
0.98
1.53
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 9V: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.81
2-Sided
95
0.67
0.98
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 14: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.95
2-Sided
95
0.81
1.12
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 18C: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.82
2-Sided
95
0.67
1.01
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 19F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
1.75
2-Sided
95
1.39
2.21
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 23F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.
GMC ratio
0.86
2-Sided
95
0.70
1.07
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 1: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.62
2-Sided
95
1.31
1.99
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 3: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
0.29
2-Sided
95
0.24
0.35
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 5: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.28
2-Sided
95
1.07
1.54
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 6A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.76
2-Sided
95
1.46
2.12
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 7F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.26
2-Sided
95
1.04
1.52
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG000
OG001
Serotype 19A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.
GMC ratio
1.85
2-Sided
95
1.54
2.24
Non-Inferiority or Equivalence
Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.
OG002
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
OG000157
OG001154
OG002163
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
OG002100.0(97.8 to 100.0)
Tetanus
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
OG002100.0(97.8 to 100.0)
Pertussis toxoid (PT)
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
OG002100.0(97.8 to 100.0)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG000100.0(97.7 to 100.0)
OG001100.0(97.6 to 100.0)
OG002100.0(97.8 to 100.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.
Percent difference
0.0
2-Sided
95
-2.4
2.3
Superiority or Other
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.
Percent difference
0.0
2-Sided
95
-2.4
2.3
Superiority or Other
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.
Percent difference
0.0
2-Sided
95
-2.4
2.3
Superiority or Other
OG000
OG002
Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.
Percent difference
0.0
2-Sided
95
-2.4
2.3
Superiority or Other
OG002
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
OG000177
OG001176
OG002175
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG0001.03(0.94 to 1.12)
OG0011.10(0.97 to 1.25)
OG0020.93(0.86 to 1.02)
Tetanus
Title
Measurements
OG0001.50(1.31 to 1.70)
OG0011.37(1.17 to 1.60)
OG0021.66(1.50 to 1.83)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.
GMC ratio
1.10
2-Sided
95
0.97
1.24
Superiority or Other
OG000
OG002
GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.
GMC ratio
0.90
2-Sided
95
0.77
1.06
Superiority or Other
OG002
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
OG000177
OG001176
OG002175
Title
Denominators
Categories
Pertussis toxoid (PT)
Title
Measurements
OG00066.12(60.45 to 72.32)
OG00157.26(49.23 to 66.60)
OG00267.64(62.87 to 72.78)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG00062.30(56.59 to 68.59)
OG00153.86(47.27 to 61.37)
OG00267.48(61.64 to 73.86)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.
GMC ratio
0.98
2-Sided
95
0.87
1.10
Superiority or Other
OG000
OG002
GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.
GMC ratio
0.92
2-Sided
95
0.81
1.05
Superiority or Other
OG002
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
OG000157
OG001154
OG002163
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG0002.65(2.43 to 2.90)
OG0013.18(2.94 to 3.45)
OG0022.63(2.39 to 2.91)
Tetanus
Title
Measurements
OG0002.90(2.56 to 3.28)
OG0012.60(2.29 to 2.95)
OG0022.89(2.58 to 3.25)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.
GMC ratio
1.01
2-Sided
95
0.88
1.15
Superiority or Other
OG000
OG002
GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.
GMC ratio
1.00
2-Sided
95
0.85
1.19
Superiority or Other
OG002
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
OG000157
OG001154
OG002163
Title
Denominators
Categories
Pertussis toxoid (PT)
Title
Measurements
OG000144.46(130.68 to 159.68)
OG001135.65(124.16 to 148.21)
OG002150.21(136.20 to 165.65)
Filamentous hemagglutinin (FHA)
Title
Measurements
OG000143.68(130.94 to 157.66)
OG001141.19(129.20 to 154.30)
OG002180.31(163.12 to 199.32)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.
GMC ratio
0.96
2-Sided
95
0.84
1.11
Superiority or Other
OG000
OG002
GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.
GMC ratio
0.80
2-Sided
95
0.70
0.91
Superiority or Other
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
OG002
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
OG000175
OG001174
OG002165
Title
Denominators
Categories
Redness- Any (n=171, 172, 165)
Title
Measurements
OG00058.5
OG00155.8
OG00210.3
Redness- Mild (n=170, 172, 165)
Title
Measurements
OG00048.2
OG00151.2
OG00210.3
Redness- Moderate (n=164, 166, 162)
Title
Measurements
OG00018.9
OG00118.1
OG0020.0
Redness- Severe (n=161, 162, 162)
Title
Measurements
OG0000.0
OG0010.6
OG0020.0
Swelling- Any (n=168, 168, 164)
Title
Measurements
OG00041.1
OG00135.7
OG0024.9
Swelling- Mild (n= 168, 168, 164)
Title
Measurements
OG00038.1
OG00131.5
OG0024.9
Swelling- Moderate (n=162, 165, 162)
Title
Measurements
OG00012.3
OG00112.7
OG0020.0
Swelling- severe (n=161, 162, 162)
Title
Measurements
OG0000.0
OG0010.6
OG0020.0
Tenderness- Any (n=163, 164, 162)
Title
Measurements
OG00013.5
OG0016.1
OG0021.2
Tenderness- Significant (n=161, 162, 162)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Any local reaction (n=175, 174, 165)
Title
Measurements
OG00068.0
OG00160.9
OG00212.1
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
OG002
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
OG000167
OG001173
OG002164
Title
Denominators
Categories
Redness- Any (n= 166, 168, 161)
Title
Measurements
OG00062.7
OG00161.9
OG00236.6
Redness- Mild (n= 166, 167, 161)
Title
Measurements
OG00056.0
OG00156.9
OG00234.8
Redness- Moderate (n= 157, 159, 156)
Title
Measurements
OG00026.1
OG00127.0
OG0028.3
Redness- Severe (n= 157, 154, 154)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Swelling- Any (n= 160, 171, 162)
Title
Measurements
OG00048.1
OG00150.9
OG00224.1
Swelling- Mild (n= 160, 170, 162)
Title
Measurements
OG00044.4
OG00148.2
OG00222.8
Swelling- Moderate (n= 157, 157, 155)
Title
Measurements
OG00019.7
OG00117.8
OG0025.8
Swelling- severe (n= 157, 154, 154)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Tenderness- Any (n= 159, 154, 155)
Title
Measurements
OG00014.5
OG0014.5
OG0021.9
Tenderness- Significant (n= 157, 154, 154)
Title
Measurements
OG0000.6
OG0010.0
OG0020.0
Any local reaction (n=167, 173, 164)
Title
Measurements
OG00071.3
OG00167.1
OG00240.2
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
OG002
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
OG000171
OG001163
OG002160
Title
Denominators
Categories
Redness- Any (n= 168, 162, 156)
Title
Measurements
OG00053.6
OG00151.2
OG00223.1
Redness- Mild (n= 167, 160, 156)
Title
Measurements
OG00047.3
OG00143.1
OG00221.8
Redness- Moderate (n= 152, 154, 153)
Title
Measurements
OG00017.1
OG00122.1
OG0022.0
Redness- Severe (n= 149, 152, 152)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Swelling- Any (n= 164, 157, 159)
Title
Measurements
OG00043.9
OG00137.6
OG00221.4
Swelling- Mild (n= 164, 156, 159)
Title
Measurements
OG00042.1
OG00134.0
OG00220.1
Swelling- Moderate (n= 150, 154, 153)
Title
Measurements
OG00010.7
OG00114.9
OG0022.6
Swelling- severe (n= 149, 152, 152)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Tenderness- Any (n= 153, 155, 153)
Title
Measurements
OG0007.8
OG0017.1
OG0022.6
Tenderness- Significant (n= 149, 152, 152)
Title
Measurements
OG0000.0
OG0010.0
OG0020.7
Any local reaction (n=171, 163, 160)
Title
Measurements
OG00062.0
OG00155.8
OG00228.8
Participants at 3 to 6 months of age received a single 0.5 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 DTaP subcutaneously administered concomitantly with each 7vPnC dose.
OG002
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
OG000153
OG001152
OG002151
Title
Denominators
Categories
Redness- Any (n= 148, 152, 149)
Title
Measurements
OG00062.2
OG00157.2
OG00234.9
Redness- Mild (n= 148, 151, 148)
Title
Measurements
OG00050.0
OG00147.7
OG00228.4
Redness- Moderate (n= 141, 139, 145)
Title
Measurements
OG00027.7
OG00127.3
OG00213.1
Redness- Severe (n= 140, 136, 141)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Swelling- Any (n= 149, 144, 148)
Title
Measurements
OG00049.0
OG00145.8
OG00226.4
Swelling- Mild (n= 147, 143, 146)
Title
Measurements
OG00042.9
OG00142.0
OG00222.6
Swelling- Moderate (n= 143, 138, 146)
Title
Measurements
OG00016.8
OG00118.8
OG00213.0
Swelling- severe (n= 140, 136, 141)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Tenderness- Any (n= 142, 140 ,142)
Title
Measurements
OG00014.1
OG00110.0
OG0025.6
Tenderness- Significant (n= 140, 136, 141)
Title
Measurements
OG0000.7
OG0010.0
OG0020.0
Any local reaction (n=153, 152, 151)
Title
Measurements
OG00068.6
OG00161.8
OG00237.1
OG002
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
OG000177
OG001174
OG002172
Title
Denominators
Categories
Fever >=37.5,=<39 degrees C (n=168, 168, 165)
Title
Measurements
OG00036.3
OG00133.9
OG00221.8
Fever >39,=<40 degrees C (n=161, 163, 162)
Title
Measurements
OG0000.6
OG0011.2
OG0020.6
Fever >40 degrees C (n=161, 162, 162)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Decreased appetite (n=163, 163, 165)
Title
Measurements
OG00012.9
OG0019.2
OG0027.3
Irritability (n=165, 164, 164)
Title
Measurements
OG00018.8
OG00116.5
OG00212.2
Increased sleep (n=170, 165, 165)
Title
Measurements
OG00028.8
OG00126.7
OG00221.8
Decreased sleep (n=164, 169, 167)
Title
Measurements
OG00018.3
OG00121.3
OG00213.8
Hives- urticaria (n=161, 162, 162)
Title
Measurements
OG0003.1
OG0011.2
OG0020.0
Use of antipyretic medication (n= 161, 162, 162)
Title
Measurements
OG0003.7
OG0012.5
OG0020.6
Any systemic event (n=177, 174, 172)
Title
Measurements
OG00061.0
OG00159.8
OG00243.0
OG002
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
OG000170
OG001169
OG002166
Title
Denominators
Categories
Fever >=37.5, =<39 degrees C (n=166, 161, 155)
Title
Measurements
OG00036.7
OG00136.6
OG00221.9
Fever >39, =<40 degrees C (n=158, 155, 154)
Title
Measurements
OG0001.9
OG0013.9
OG0020.6
Fever >40 degrees C (n=157, 154, 154)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Decreased appetite (n=158, 159, 155)
Title
Measurements
OG00011.4
OG00114.5
OG0027.1
Irritability (n=162, 155, 156)
Title
Measurements
OG00017.9
OG00118.7
OG00210.9
Increased sleep (n=163, 158, 163)
Title
Measurements
OG00022.7
OG00122.2
OG00222.7
Decreased sleep (n=161, 157, 157)
Title
Measurements
OG00018.6
OG00112.1
OG00212.1
Hives- urticaria (n=157, 154, 154)
Title
Measurements
OG0002.5
OG0011.3
OG0021.9
Use of antipyretic medication (n=160, 155, 154)
Title
Measurements
OG0003.1
OG0014.5
OG0021.3
Any systemic event (n=170, 169, 166)
Title
Measurements
OG00061.2
OG00157.4
OG00244.6
OG002
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
OG000168
OG001164
OG002159
Title
Denominators
Categories
Fever >=37.5, =<39 degrees C (n=162, 161, 157)
Title
Measurements
OG00034.6
OG00130.4
OG00224.2
Fever >39, =<40 degrees C (n=150, 152, 153)
Title
Measurements
OG0003.3
OG0012.0
OG0023.3
Fever >40 degrees C (n=149, 152, 152)
Title
Measurements
OG0000.0
OG0010.7
OG0020.0
Decreased appetite (n=152, 155, 154)
Title
Measurements
OG0009.9
OG0019.7
OG0025.8
Irritability (n=154, 156, 154)
Title
Measurements
OG00017.5
OG00114.7
OG00211.7
Increased sleep (n=151, 157, 154)
Title
Measurements
OG00020.5
OG00120.4
OG00214.9
Decreased sleep (n= 154, 156, 153)
Title
Measurements
OG00018.2
OG00112.8
OG0029.8
Hives- urticaria (n= 149, 152, 152)
Title
Measurements
OG0001.3
OG0010.0
OG0021.3
Use of antipyretic medication (n=150, 153, 154)
Title
Measurements
OG0002.0
OG0013.3
OG0024.5
Any systemic event (n=168, 164, 159)
Title
Measurements
OG00057.7
OG00150.0
OG00240.9
OG002
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.