Study Comparing 13-valent Pneumococcal Conjugate Vaccine... | NCT00373958 | Trialant
NCT00373958
Sponsor
Pfizer
Status
Completed
Last Update Posted
Feb 21, 2013Estimated
Enrollment
666Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal
Interventions
13 valent pneumococcal conjugate vaccine
7vPnc pneumococcal conjugate vaccine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00373958
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-004
Secondary IDs
Not provided
Brief Title
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Official Title
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2006
Primary Completion Date
Jun 2008Actual
Completion Date
Jun 2008Actual
First Submitted Date
Sep 7, 2006
First Submission Date that Met QC Criteria
Sep 7, 2006
First Posted Date
Sep 8, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2010
Results First Submitted that Met QC Criteria
Jan 17, 2013
Results First Posted Date
Feb 21, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 26, 2009
Certification/Extension First Submitted that Passed QC Review
Jul 31, 2009
Certification/Extension First Posted Date
Oct 2, 2009Estimated
Last Update Submitted Date
Jan 17, 2013
Last Update Posted Date
Feb 21, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
One month after the 3-dose infant series (7 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
1 Month After the Toddler Dose
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).
One Month After the Infant Series (7 months of age)
Percentage of Participants Reporting Pre-specified Systemic Events
Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
One month after toddler dose (13 to 16 months of age)
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month-old infants.
Available for the entire study period.
Exclusion criteria:
Previous vaccination with any vaccine before the start of the study.
Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Recruitment Details
Participants were recruited in the United States from September 2006 to January 2008.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler 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
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Not provided
13vPnC vaccine
7vPnc pneumococcal conjugate vaccine
Biological
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
7vPnC vaccine
Within 7 days after each dose
Percentage of Participants Reporting Pre-specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], 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 ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category.
Within 7 days after each dose
one month after the toddler dose
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.
one month after the toddler dose
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
one month after the toddler dose
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.
One month after infant series and one month after toddler dose
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.
one month after the infant series and the toddler dose
Jonesboro
Arkansas
72401
United States
Little Rock
Arkansas
72205
United States
Downey
California
90242
United States
Fontana
California
92335
United States
Loma Linda
California
92354
United States
Paramount
California
90723
United States
Riverside
California
92505
United States
Centennial
Colorado
80112
United States
Norwich
Connecticut
06360
United States
Tampa
Florida
33606
United States
Marietta
Georgia
30062
United States
Woodstock
Georgia
30189
United States
Chicago
Illinois
60612
United States
Park Ridge
Illinois
60068
United States
Overland Park
Kansas
66212
United States
Bardstown
Kentucky
40004
United States
Louisville
Kentucky
40202
United States
Louisville
Kentucky
40207
United States
Rochester
New York
14620
United States
The Bronx
New York
10467
United States
Cincinnati
Ohio
45245
United States
Cleveland
Ohio
44118
United States
Mason
Ohio
45040
United States
Latrobe
Pennsylvania
15650
United States
Pittsburgh
Pennsylvania
15227
United States
Pittsburgh
Pennsylvania
15236
United States
Pittsburgh
Pennsylvania
15241
United States
Sellersville
Pennsylvania
18960
United States
Wexford
Pennsylvania
15090
United States
Charleston
South Carolina
29425
United States
Jackson
Tennessee
38305
United States
The Woodlands
Texas
77380
United States
Murray
Utah
84107
United States
Provo
Utah
84604
United States
Richmond
Virginia
23219
United States
Vienna
Virginia
22180
United States
Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.
FG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
FG000334 subjectsOne participant was prerandomized but not consented.
FG001332 subjects
Vaccinated Dose 1
FG000332 subjects
FG001331 subjects
Vaccinated Dose 2
FG000309 subjects
FG001305 subjects
Vaccinated Dose 3
FG000298 subjects
FG001300 subjects
COMPLETED
FG000294 subjects
FG001290 subjects
NOT COMPLETED
FG00040 subjects
FG00142 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00013 subjects
FG00115 subjects
Failed to return
FG0008 subjects
FG00113 subjects
Lost to Follow-up
FG0006 subjects
FG0015 subjects
Protocol Violation
FG0003 subjects
FG0017 subjects
Lost Kaiser coverage
FG0004 subjects
FG0010 subjects
Child relocated
FG0001 subjects
FG0010 subjects
Consent was not received
FG0001 subjects
FG0010 subjects
Adverse Event
FG0003 subjects
FG0011 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000294 subjects
FG001290 subjects
Withdrawn After Infant Series
FG00022 subjects
FG00125 subjects
Vaccinated Toddler Dose
FG000272 subjects
FG001265 subjects
COMPLETED
FG000264 subjects
FG001252 subjects
NOT COMPLETED
FG00030 subjects
FG00138 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0005 subjects
FG0018 subjects
Withdrawal by Subject
FG0002 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
BG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000334
BG001332
BG002666
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0002.1± 0.3
BG0012.1± 0.3
BG0022.1± 0.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000165
BG001139
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 Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after the 3-dose infant series (7 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Units
Counts
Participants
OG000252
OG001252
Title
Denominators
Categories
Common Serotypes - Serotype 4 (n=252,251)
Title
Measurements
OG00094.4(90.9 to 96.9)
OG00198.0(95.4 to 99.4)
Common Serotypes - Serotype 6B (n=252,250)
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
For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
-3.6
95
-7.3
-0.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Primary
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
1 Month After the Toddler Dose
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG001
7vPnC
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).
Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of participants
One Month After the Infant Series (7 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Secondary
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after toddler dose (13 to 16 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Secondary
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
µg/mL
one month after the toddler dose
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Secondary
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.
The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
index value
one month after the toddler dose
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Secondary
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
IU/mL
one month after the toddler dose
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Primary
Percentage of Participants Reporting Pre-specified Systemic Events
Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.
Posted
Mar 2010
Number
Percentage of participants
Within 7 days after each dose
ID
Title
Description
OG000
13vPnC Dose 1
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
Primary
Percentage of Participants Reporting Pre-specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], 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 ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category.
Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.
Posted
Mar 2010
Number
Percentage of participants
Within 7 days after each dose
ID
Title
Description
OG000
13vPnC Dose 1
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
Secondary
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after infant series and one month after toddler dose
ID
Title
Description
OG000
13vPnC After Infant Series
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
OG001
7vPnC After Infant Series
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Secondary
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
titer
one month after the infant series and the toddler dose
ID
Title
Description
OG000
13vPnC After the Infant Series
Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
OG001
7vPnC After the Infant Series
Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
OG002
Time Frame
Adverse events were collected throughout the study.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
13vPnC Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
17
332
272
332
EG001
7vPnC Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
16
331
263
331
EG002
13vPnC Post Infant Series
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
5
332
31
332
EG003
7vPnC Post Infant Series
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
7
330
29
330
EG004
13vPnC Toddler Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
3
267
183
267
EG005
7vPnC Toddler Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
4
258
163
258
EG006
13vPnC 6-Month Follow-up
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
9
330
11
330
EG007
7vPnC 6-Month Follow-up
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
5
329
10
329
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess neck
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG0031 affected330 at risk
EG0040 affected267 at risk
EG0050 affected258 at risk
EG0060 affected330 at risk
EG0070 affected329 at risk
Accidental exposure
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0016 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Cellulitis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Congenital megacolon
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Constipation
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Convulsion
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Croup infectious
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Epilepsy
Nervous system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Febrile convulsion
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Gastroenteritis viral
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Mastoiditis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Near drowning
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Nephroblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Otitis media
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Pneumonia viral
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Postical paralysis
Nervous system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Rectal abscess
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0003 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Rhinitis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Selective IgA immunodeficiency
Immune system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Status asthmaticus
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Subcutaneous abscess
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Thromboycytopenia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Varicella
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG0030 affected330 at risk
EG0042 affected267 at risk
EG0051 affected258 at risk
EG0061 affected330 at risk
EG0070 affected329 at risk
Lymphadenopathy
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Plagiocephaly
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0016 affected331 at risk
EG0021 affected332 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Macrocephaly
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Dermoid cyst
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Patent ductus arteriosus
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Pectus excavatum
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Pilonidal cyst congenital
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Thalassaemia trait
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Hip dysplasia
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Sickle cell trait
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Haemoglobin C trait
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Talipes
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Tibial torsion
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Ear pain
Ear and labyrinth disorders
Non-systematic Assessment
EG0005 affected332 at risk
EG0016 affected331 at risk
EG0020 affected332 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
Non-systematic Assessment
EG0004 affected332 at risk
EG0014 affected331 at risk
EG0020 affected332 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Precocious puberty
Endocrine disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Conjunctivitis
Eye disorders
Non-systematic Assessment
EG00022 affected332 at risk
EG00124 affected331 at risk
EG0021 affected332 at risk
EG003
Eye discharge
Eye disorders
Non-systematic Assessment
EG0004 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Eye swelling
Eye disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Strabismus
Eye disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0011 affected331 at risk
EG0021 affected332 at risk
EG003
Lacrimation increased
Eye disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Dacryostenosis acquired
Eye disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Eyelid irritation
Eye disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Scleral haemorrhage
Eye disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Non-systematic Assessment
EG00035 affected332 at risk
EG00131 affected331 at risk
EG0022 affected332 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG00023 affected332 at risk
EG00125 affected331 at risk
EG0020 affected332 at risk
EG003
Constipation
Gastrointestinal disorders
Non-systematic Assessment
EG00016 affected332 at risk
EG00121 affected331 at risk
EG0020 affected332 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Non-systematic Assessment
EG00011 affected332 at risk
EG00123 affected331 at risk
EG0021 affected332 at risk
EG003
Teething
Gastrointestinal disorders
Non-systematic Assessment
EG0004 affected332 at risk
EG0017 affected331 at risk
EG0020 affected332 at risk
EG003
Flatulence
Gastrointestinal disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Anal fissure
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Infantile spitting up
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Nausea
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0021 affected332 at risk
EG003
Abdominal wall disorder
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Dysphagia
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Gingival cyst
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Rectal fissure
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Anal skin tags
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Enamel anomaly
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Ileus
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG00029 affected332 at risk
EG00121 affected331 at risk
EG0021 affected332 at risk
EG003
Irritability
General disorders
Non-systematic Assessment
EG0004 affected332 at risk
EG0017 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site erythema
General disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site swelling
General disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site bruising
General disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site induration
General disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Xerosis
General disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Developmental delay
General disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Hernia
General disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Influenza like illness
General disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site pain
General disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site rash
General disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Injection site reaction
General disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Oedema peripheral
General disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Allergy to metals
Immune system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Drug hypersensitivity
Immune system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Food allergy
Immune system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Hypersensitivity
Immune system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0021 affected332 at risk
EG003
Milk allergy
Immune system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Seasonal allergy
Immune system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG000131 affected332 at risk
EG001131 affected331 at risk
EG0023 affected332 at risk
EG003
Otitis media
Infections and infestations
Non-systematic Assessment
EG00094 affected332 at risk
EG00177 affected331 at risk
EG0023 affected332 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG00052 affected332 at risk
EG00149 affected331 at risk
EG0021 affected332 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG00021 affected332 at risk
EG00118 affected331 at risk
EG0021 affected332 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG00018 affected332 at risk
EG00120 affected331 at risk
EG0020 affected332 at risk
EG003
Otitis media acute
Infections and infestations
Non-systematic Assessment
EG00012 affected332 at risk
EG00122 affected331 at risk
EG0020 affected332 at risk
EG003
Viral infection
Infections and infestations
Non-systematic Assessment
EG00013 affected332 at risk
EG00118 affected331 at risk
EG0020 affected332 at risk
EG003
Candidiasis
Infections and infestations
Non-systematic Assessment
EG00011 affected332 at risk
EG00116 affected331 at risk
EG0020 affected332 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG00010 affected332 at risk
EG00111 affected331 at risk
EG0021 affected332 at risk
EG003
Sinusitis
Infections and infestations
Non-systematic Assessment
EG00012 affected332 at risk
EG0016 affected331 at risk
EG0020 affected332 at risk
EG003
Oral candidiasis
Infections and infestations
Non-systematic Assessment
EG00010 affected332 at risk
EG0014 affected331 at risk
EG0020 affected332 at risk
EG003
Pharyngitis
Infections and infestations
Non-systematic Assessment
EG0007 affected332 at risk
EG0016 affected331 at risk
EG0020 affected332 at risk
EG003
Rhinitis
Infections and infestations
Non-systematic Assessment
EG0005 affected332 at risk
EG0018 affected331 at risk
EG0021 affected332 at risk
EG003
Candida nappy rash
Infections and infestations
Non-systematic Assessment
EG0007 affected332 at risk
EG0015 affected331 at risk
EG0020 affected332 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
EG0007 affected332 at risk
EG0015 affected331 at risk
EG0020 affected332 at risk
EG003
Croup infectious
Infections and infestations
Non-systematic Assessment
EG0005 affected332 at risk
EG0015 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
Non-systematic Assessment
EG0005 affected332 at risk
EG0015 affected331 at risk
EG0020 affected332 at risk
EG003
Viral skin infection
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0015 affected331 at risk
EG0020 affected332 at risk
EG003
Gastroenteritis viral
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0014 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0014 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Skin candida
Infections and infestations
Non-systematic Assessment
EG0004 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0013 affected331 at risk
EG0020 affected332 at risk
EG003
Ear infection
Infections and infestations
Non-systematic Assessment
EG0003 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Impetigo
Infections and infestations
Non-systematic Assessment
EG0003 affected332 at risk
EG0011 affected331 at risk
EG0021 affected332 at risk
EG003
Viral pharyngitis
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0012 affected331 at risk
EG0021 affected332 at risk
EG003
Body tinea
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Fungal skin infection
Infections and infestations
Non-systematic Assessment
EG0003 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Influenza
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Intertrigo candida
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Tinea capitis
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0013 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchiectasis
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Conjunctivitis viral
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Ear lobe infection
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Eye infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Folliculitis
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Genital candidiasis
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory tract infection viral
Infections and infestations
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Acute sinusitis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Breast cellulitis
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchitis viral
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Conjunctivitis infective
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Eczema infected
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Enteritis infectious
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Enterobiasis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Erythema infectiosum
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Fungal infection
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Gastritis viral
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Laryngitis
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Otitis externa
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Paronychia
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Rash pustular
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Roseola
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Staphylococcal infection
Infections and infestations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Viraemia
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Otitis media chronic
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Infected insect bite
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Tinea infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Varicella
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Wound infection staphylococcal
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
External ear cellulitis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Cellulitis
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Lice infestation
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Oral fungal infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Oral herpes
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Viral diarrhoea
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Rotavirus infection
Infections and infestations
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Fall
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Cardiac murmur
Investigations
Non-systematic Assessment
EG0002 affected332 at risk
EG0012 affected331 at risk
EG0021 affected332 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Cardiac murmur functional
Investigations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Head circumference abnormal
Investigations
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Weight decreased
Investigations
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0013 affected331 at risk
EG0020 affected332 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Anorexia
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Obesity
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Lactose intolerance
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Nose deformity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Weight bearing difficulty
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Premature closure of cranial sutures
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Benign vaginal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Tremor
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Convulsion
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Headache
Nervous system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Hypersomnia
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Hypertonia
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Hypokinesia
Nervous system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Lethargy
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Nystagmus
Nervous system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Somnolence
Nervous system disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Speech disorder developmental
Nervous system disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Crying
Psychiatric disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Insomnia
Psychiatric disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Restlessness
Psychiatric disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Staring
Psychiatric disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Crystalluria
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Penile adhesion
Reproductive system and breast disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0013 affected331 at risk
EG0020 affected332 at risk
EG003
Genital discomfort
Reproductive system and breast disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Genital erythema
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Penile blister
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Penis disorder
Reproductive system and breast disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Testicular retraction
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00028 affected332 at risk
EG00139 affected331 at risk
EG0020 affected332 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00036 affected332 at risk
EG00125 affected331 at risk
EG0020 affected332 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00016 affected332 at risk
EG00117 affected331 at risk
EG0021 affected332 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00011 affected332 at risk
EG00114 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0006 affected332 at risk
EG0019 affected331 at risk
EG0020 affected332 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0004 affected332 at risk
EG0016 affected331 at risk
EG0021 affected332 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0014 affected331 at risk
EG0021 affected332 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0014 affected331 at risk
EG0023 affected332 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00031 affected332 at risk
EG00131 affected331 at risk
EG0021 affected332 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00021 affected332 at risk
EG00113 affected331 at risk
EG0022 affected332 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0007 affected332 at risk
EG00117 affected331 at risk
EG0021 affected332 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0008 affected332 at risk
EG00113 affected331 at risk
EG0020 affected332 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0007 affected332 at risk
EG00112 affected331 at risk
EG0020 affected332 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0006 affected332 at risk
EG0017 affected331 at risk
EG0020 affected332 at risk
EG003
Seborrhoea
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0015 affected331 at risk
EG0020 affected332 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0003 affected332 at risk
EG0013 affected331 at risk
EG0021 affected332 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0013 affected331 at risk
EG0020 affected332 at risk
EG003
Acne infantile
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Dandruff
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0002 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0012 affected331 at risk
EG0020 affected332 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Cafe au lait spots
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Pityriasis alba
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Post inflammatory pigmentation change
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Umbilical erythema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0021 affected332 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Rash rubelliform
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Exposure to communicable disease
Social circumstances
Non-systematic Assessment
EG0001 affected332 at risk
EG0010 affected331 at risk
EG0020 affected332 at risk
EG003
Haematoma
Vascular disorders
Non-systematic Assessment
EG0000 affected332 at risk
EG0011 affected331 at risk
EG0020 affected332 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
EG000192 affected264 at risk
EG001195 affected270 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (any)
EG000154 affected200 at risk
EG001164 affected216 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (any)
EG000140 affected178 at risk
EG001140 affected173 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
EG00025 affected182 at risk
EG00118 affected195 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant)
EG00013 affected123 at risk
EG00115 affected131 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (significant)
EG0008 affected91 at risk
EG0018 affected86 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
EG00055 affected201 at risk
EG00151 affected216 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (any)
EG00044 affected141 at risk
EG00143 affected146 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (any)
EG00044 affected116 at risk
EG00138 affected103 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
EG00046 affected199 at risk
EG00145 affected212 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (mild)
EG00042 affected141 at risk
EG00137 affected142 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (mild)
EG00040 affected113 at risk
EG00138 affected103 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration
EG00012 affected176 at risk
EG00110 affected193 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (moderate)
EG0006 affected118 at risk
EG0019 affected126 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (moderate)
EG0006 affected91 at risk
EG0015 affected82 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm.
EG0000 affected173 at risk
EG0010 affected187 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (severe)
EG0000 affected116 at risk
EG0010 affected120 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (severe)
EG0000 affected87 at risk
EG0010 affected79 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
EG00072 affected202 at risk
EG00172 affected223 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (any)
EG00070 affected155 at risk
EG00162 affected164 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (any)
EG00064 affected131 at risk
EG00159 affected118 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
EG00069 affected200 at risk
EG00169 affected220 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Systematic Assessment
Infant Series Dose 2; Erythema (mild)
EG00069 affected155 at risk
EG00160 affected162 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (mild)
EG00061 affected128 at risk
EG00157 affected117 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
EG0008 affected177 at risk
EG0015 affected191 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (moderate)
EG0002 affected117 at risk
EG0014 affected124 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (moderate)
EG0005 affected91 at risk
EG0014 affected80 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm.
EG0000 affected173 at risk
EG0010 affected186 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (severe)
EG0000 affected116 at risk
EG0010 affected120 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (severe)
EG0000 affected87 at risk
EG0010 affected79 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C
EG00047 affected196 at risk
EG00143 affected203 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C
EG00063 affected146 at risk
EG00161 affected151 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C
EG00049 affected123 at risk
EG00140 affected106 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever >39 degrees C but ≤40 degrees C
EG0005 affected177 at risk
EG0010 affected187 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
Skin and subcutaneous tissue disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >39 degrees C but ≤40 degrees C
EG0003 affected118 at risk
EG0016 affected123 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever >39 degrees C but ≤40 degrees C
EG0008 affected94 at risk
EG0012 affected81 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever >40 degrees C
EG0000 affected174 at risk
EG0010 affected187 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >40 degrees C
EG0000 affected116 at risk
EG0011 affected121 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever >40 degrees C
EG0000 affected87 at risk
EG0011 affected80 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG000125 affected228 at risk
EG001108 affected238 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG000106 affected177 at risk
EG00191 affected174 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00087 affected147 at risk
EG00181 affected136 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG000259 affected289 at risk
EG001249 affected290 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG000212 affected236 at risk
EG001216 affected236 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Irritability
EG000191 affected216 at risk
EG001201 affected218 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG000213 affected268 at risk
EG001212 affected270 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG000161 affected203 at risk
EG001147 affected200 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG000117 affected164 at risk
EG001104 affected149 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG000101 affected221 at risk
EG001113 affected236 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00083 affected169 at risk
EG00196 affected172 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00093 affected154 at risk
EG00185 affected134 at risk
EG0020 affected0 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Hives (urticaria)
EG0003 affected178 at risk
EG0012 affected188 at risk
EG0020 affected0 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Hives (urticaria)
EG0003 affected118 at risk
EG0010 affected120 at risk
EG0020 affected0 at risk
EG003
Hives (urticaria)
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Hives (urticaria)
EG0004 affected89 at risk
EG0010 affected79 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
2 subjects
Failed to return
FG0001 subjects
FG0012 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
Withdrawn after infant series
FG00022 subjects
FG00125 subjects
304
Male
BG000169
BG001193
BG002362
87.3
(82.5 to 91.1)
OG00192.8(88.9 to 95.7)
Common Serotypes - Serotype 9V (n=252,252)
Title
Measurements
OG00090.5(86.2 to 93.8)
OG00198.4(96.0 to 99.6)
Common Serotypes - Serotype 14 (n=251,252)
Title
Measurements
OG00097.6(94.9 to 99.1)
OG00197.2(94.4 to 98.9)
Common Serotypes - Serotype 18C (n=252,252)
Title
Measurements
OG00096.8(93.8 to 98.6)
OG00198.4(96.0 to 99.6)
Common Serotypes - Serotype 19F (n=252,251)
Title
Measurements
OG00098.0(95.4 to 99.4)
OG00197.6(94.9 to 99.1)
Common Serotypes - Serotype 23F (n=252,252)
Title
Measurements
OG00090.5(86.2 to 93.8)
OG00194.0(90.4 to 96.6)
Additional Serotypes - Serotype 1 (n=252,248)
Title
Measurements
OG00095.6(92.3 to 97.8)
OG0011.6(0.4 to 4.1)
Additional Serotypes - Serotype 3 (n=249,241)
Title
Measurements
OG00063.5(57.1 to 69.4)
OG0014.6(2.3 to 8.0)
Additional Serotypes - Serotype 5 (n=252,197)
Title
Measurements
OG00089.7(85.2 to 93.1)
OG00131.0(24.6 to 37.9)
Additional Serotypes - Serotype 6A (n=252,240)
Title
Measurements
OG00096.0(92.8 to 98.1)
OG00142.5(36.2 to 49.0)
Additional Serotypes - Serotype 7F (n=252,248)
Title
Measurements
OG00098.4(96.0 to 99.6)
OG0012.8(1.1 to 5.7)
Additional Serotypes - Serotype 19A (n=251,238)
Title
Measurements
OG00098.4(96.0 to 99.6)
OG00186.6(81.6 to 90.6)
OG000
OG001
For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
-5.5
95
-10.9
-0.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
OG000
OG001
For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
-7.9
95
-12.4
-4.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
OG000
OG001
For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
0.4
95
-2.7
3.5
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
OG000
OG001
For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
-1.6
95
-4.7
1.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
OG000
OG001
For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
0.4
95
-2.4
3.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
OG000
OG001
For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
-3.6
95
-8.5
1.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Units
Counts
Participants
OG000239
OG001223
Title
Denominators
Categories
Common Serotypes - Serotype 4 (n=235,223)
Title
Measurements
OG0003.73(3.28 to 4.24)
OG0015.49(4.91 to 6.13)
Common Serotypes - Serotype 6B (n=234,223)
Title
Measurements
OG00011.53(9.99 to 13.30)
OG00115.63(13.80 to 17.69)
Common Serotypes - Serotype 9V (n=234,223)
Title
Measurements
OG0002.62(2.32 to 2.94)
OG0013.63(3.25 to 4.05)
Common Serotypes - Serotype 14 (n=235,223)
Title
Measurements
OG0009.11(7.95 to 10.45)
OG00112.72(11.22 to 14.41)
Common Serotypes - Serotype 18C (n=236,223)
Title
Measurements
OG0003.20(2.82 to 3.64)
OG0014.70(4.18 to 5.28)
Common Serotypes - Serotype 19F (n=235,223)
Title
Measurements
OG0006.60(5.85 to 7.44)
OG0015.60(4.87 to 6.43)
Common Serotypes - Serotype 23F (n=234,222)
Title
Measurements
OG0005.07(4.41 to 5.83)
OG0017.84(6.91 to 8.90)
Additional Serotypes - Serotype 1 (n=235,223)
Title
Measurements
OG0005.06(4.43 to 5.80)
OG0010.03(0.03 to 0.03)
Additional Serotypes - Serotype 3 (n=232,223)
Title
Measurements
OG0000.94(0.83 to 1.05)
OG0010.07(0.05 to 0.08)
Additional Serotypes - Serotype 5 (n=235,223)
Title
Measurements
OG0003.72(3.31 to 4.18)
OG0010.55(0.47 to 0.64)
Additional Serotypes - Serotype 6A (n=235,223)
Title
Measurements
OG0008.20(7.30 to 9.20)
OG0011.87(1.60 to 2.19)
Additional Serotypes - Serotype 7F (n=235,223)
Title
Measurements
OG0005.67(5.01 to 6.42)
OG0010.05(0.04 to 0.05)
Additional Serotypes - Serotype 19A (n=236,223)
Title
Measurements
OG0008.55(7.64 to 9.56)
OG0013.54(3.15 to 3.98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.68
95
0.57
0.80
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG000
OG001
For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.74
95
0.61
0.89
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG000
OG001
For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.72
95
0.62
0.85
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG000
OG001
For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.72
95
0.60
0.86
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG000
OG001
For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.68
95
0.57
0.81
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG000
OG001
For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.18
95
0.98
1.41
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG000
OG001
For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.65
95
0.54
0.78
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Units
Counts
Participants
OG000252
OG001252
Title
Denominators
Categories
Hib 0.15 µg/mL (n=237,230)
Title
Measurements
OG00097.9(95.1 to 99.3)
OG00197.8(95.0 to 99.3)
Hib 1.0 µg/mL (n=237,230)
Title
Measurements
OG00077.6(71.8 to 82.8)
OG00178.3(72.4 to 83.4)
Diphtheria [IU]/mL (n=233,230)
Title
Measurements
OG00095.7(92.2 to 97.9)
OG00196.1(92.7 to 98.2)
FHA [EU]/mL (n=239,240)
Title
Measurements
OG00096.7(93.5 to 98.5)
OG00195.0(91.4 to 97.4)
PT [EU]/mL (n=239,240)
Title
Measurements
OG00094.1(90.4 to 96.8)
OG00195.0(91.4 to 97.4)
PRN [EU]/mL (n=239,240)
Title
Measurements
OG00093.7(89.9 to 96.4)
OG00195.8(92.5 to 98.0)
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
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.
Difference
0.1
95
-2.9
3.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.
OG000
OG001
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.
Difference
-0.6
95
-8.3
7.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.
OG000
OG001
For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Difference
-0.4
95
-4.3
3.5
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.
OG000
OG001
For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.
Difference
1.7
95
-2.1
5.6
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.
OG000
OG001
For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.
Difference
-0.9
95
-5.2
3.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.
OG000
OG001
For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.
Difference
-2.1
95
-6.4
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.
Units
Counts
Participants
OG000239
OG001223
Title
Denominators
Categories
Measles ≥1.10 I.V. (n=221,210)
Title
Measurements
OG00096.4(93.0 to 98.4)
OG00197.1(93.9 to 98.9)
Mumps ≥1.10 I.V. (n=221,210)
Title
Measurements
OG00076.5(70.3 to 81.9)
OG00172.9(66.3 to 78.7)
Rubella ≥15 IU/mL (n=209,204)
Title
Measurements
OG00091.9(87.3 to 95.2)
OG00190.7(85.8 to 94.3)
Varicella ≥1.09 I.V. (n=221,210)
Title
Measurements
OG00026.7(21.0 to 33.0)
OG00121.9(16.5 to 28.1)
Hib (PRP) 0.15 µg/mL (n=230,214)
Title
Measurements
OG000100.0(98.4 to 100.0)
OG001100.0(98.3 to 100.0)
Hib (PRP) 1.0 µg/mL (n=230,214)
Title
Measurements
OG00090.4(85.9 to 93.9)
OG00192.1(87.6 to 95.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.
Difference
0.0
95
-1.6
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.
Difference
-1.6
95
-7.1
3.8
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.
Difference
-0.8
95
-4.5
2.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -5%.
OG000
OG001
For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.
Difference
3.6
95
-4.7
11.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -5%.
OG000
OG001
For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.
Difference
1.2
95
-4.4
6.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -5%.
OG000
OG001
For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.
Difference
4.8
95
-3.4
13.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Units
Counts
Participants
OG000248
OG001231
Title
Denominators
Categories
Title
Measurements
OG0006.84(5.85 to 7.99)
OG0017.30(6.21 to 8.59)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.94
95
0.75
1.17
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Units
Counts
Participants
OG000239
OG001227
Title
Denominators
Categories
Measles
Title
Measurements
OG0001.98(1.81 to 2.16)
OG0012.06(1.90 to 2.23)
Mumps
Title
Measurements
OG0001.32(1.19 to 1.46)
OG0011.32(1.20 to 1.45)
Varicella
Title
Measurements
OG0000.74(0.69 to 0.79)
OG0010.73(0.69 to 0.77)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For Measles the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.96
2-Sided
95
0.85
1.08
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Mumps the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.00
2-Sided
95
0.87
1.14
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Varicella the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.01
2-Sided
95
0.92
1.10
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Units
Counts
Participants
OG000227
OG001221
Title
Denominators
Categories
Title
Measurements
OG00076.53(64.55 to 90.72)
OG00197.69(82.28 to 115.98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For Rubella the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.78
2-Sided
95
0.62
1.00
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
OG004
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
OG005
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
OG006
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG007
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Units
Counts
Participants
OG000332
OG001331
OG002309
OG003305
OG004298
OG005300
OG006272
OG007265
Title
Denominators
Categories
Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76
Title
Measurements
OG00024.0
OG00121.2
OG00243.2
OG00340.4
OG00439.8
OG00537.7
OG00653.5
OG00751.3
Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
OG004
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
OG005
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
OG006
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
OG007
7vPnC Toddler Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
OG003
7vPnC After Toddler Dose
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
OG003
7vPnC After the Toddler Dose
Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.