Study to Evaluate a 13-valent Pneumococcal Conjugate Vacc... | NCT00366340 | Trialant
NCT00366340
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Aug 8, 2012Estimated
Enrollment
604Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal
Interventions
13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT00366340
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-006
Secondary IDs
Not provided
Brief Title
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Official Title
A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2012
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
Oct 2006
Primary Completion Date
Aug 2008Actual
Completion Date
Aug 2008Actual
First Submitted Date
Aug 17, 2006
First Submission Date that Met QC Criteria
Aug 18, 2006
First Posted Date
Aug 21, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2010
Results First Submitted that Met QC Criteria
Jun 28, 2012
Results First Posted Date
Aug 8, 2012Estimated
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
Aug 8, 2012Estimated
Last Update Submitted Date
Jun 28, 2012
Last Update Posted Date
Aug 8, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
1
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
Percentage 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 3-dose infant series (5 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (GMC) 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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
One month after 3-dose infant series (5 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
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 3-dose infant series (5 months of age)
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody functionality/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.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 2 months (56 to 112 days) at time of enrollment.
Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion criteria:
Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.
History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Recruitment Details
Participants were recruited in Germany from October 2006 to April 2007.
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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
2
One month after 3-dose infant series (5 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.
Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
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). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Day 1 through 4 after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Day 1 through 4 after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Day 1 through 4 after each dose
Bad Saulgau
88348
Germany
Bad Sobernheim
55566
Germany
Berlin
10551
Germany
Berlin
10967
Germany
Berlin
13355
Germany
Berlin
13409
Germany
Berlin
13507
Germany
Berlin
13627
Germany
Birkenfeld
75217
Germany
Bobingen
86399
Germany
Bramsche
49565
Germany
Bretten
75015
Germany
Cham
93413
Germany
Ehingen
89584
Germany
Erlangen
91056
Germany
Eschwege
37269
Germany
Flensburg
24939
Germany
Gau-Odernheim
55239
Germany
Hamburg
22763
Germany
Herzogenaurach
91074
Germany
Höchberg
97204
Germany
Kehl
77694
Germany
Kiel
24111
Germany
Kleve
47533
Germany
Krefeld
47798
Germany
Ludwigshafen
67059
Germany
Lübeck
23568
Germany
Mainz
55101
Germany
Metzingen
72555
Germany
Minden
32427
Germany
Münster
48159
Germany
Münster
48165
Germany
Neumünster
24534
Germany
Neumünster
24534
Germany
Neustadt/Aisch
91413
Germany
Niebüll
25899
Germany
Nuremberg
90473
Germany
Nuremberg
90482
Germany
Oberkirch
77704
Germany
Olching
82140
Germany
Pforzheim
75172
Germany
Porta Westfalica
32457
Germany
Ravensburg
88214
Germany
Tettnang
88069
Germany
Vellmar
34246
Germany
Weiden
92637
Germany
Weilheim
82362
Germany
Welzheim
73642
Germany
Wiesbaden
65205
Germany
Zirndorf
90513
Germany
FG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
FG000301 subjects
FG001303 subjects
Vaccinated Dose 1
FG000300 subjects
FG001303 subjects
Vaccinated Dose 2
FG000296 subjects
FG001297 subjects
Vaccinated Dose 3
FG000294 subjects
FG001293 subjects
COMPLETED
FG000293 subjects
FG001293 subjects
NOT COMPLETED
FG0008 subjects
FG00110 subjects
Type
Comment
Reasons
Protocol Violation
FG0003 subjects
FG0014 subjects
Withdrawal by Subject
FG0003 subjects
FG0013 subjects
Adverse Event
FG0000 subjects
FG0012 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
Failure to return
FG0001 subjects
FG0010 subjects
After the Infant Series
Type
Comment
Milestone Data
STARTED
FG000293 subjects
FG001293 subjects
COMPLETED
FG000290 subjects
FG001287 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
Type
Comment
Reasons
Parent/legal guardian request
FG0001 subjects
FG0011 subjects
Failed to return
FG0000 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000290 subjects
FG001287 subjects
COMPLETED
FG000289 subjects
FG001286 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
Type
Comment
Reasons
Failed to return
FG0001 subjects
FG0010 subjects
Parent/legal guardian request
FG0000 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
BG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000301
BG001303
BG002604
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
BG0002.5± 0.6
BG0012.5± 0.6
BG0022.5± 0.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000151
BG001127
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
Percentage 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 eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of Participants
One month after 3-dose infant series (5 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Units
Counts
Participants
OG000285
OG001279
Title
Denominators
Categories
Common Serotypes-Serotype 4
Title
Measurements
OG00098.2(96.0 to 99.4)
OG00198.2(95.9 to 99.4)
Common Serotypes-Serotype 6B
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
0.0
2-Sided
95
-2.5
2.6
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest 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 After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (GMC) 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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
One month after 3-dose infant series (5 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Primary
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
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 consisting of eligible participants who adhered to 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 3-dose infant series (5 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Primary
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody functionality/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 participants who adhered to 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 3-dose infant series (5 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of Participants
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG001
7vPnC After Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
Primary
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, 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 concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG001
7vPnC After Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG002
13vPnC AfterToddler Dose
Primary
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, 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 concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
IU/mL
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG001
7vPnC After Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG002
13vPnC AfterToddler Dose
Primary
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, 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 concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
mIU/mL
One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG001
7vPnC After Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
Primary
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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 who adhered to protocol requirements, 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 concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
OG001
7vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 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). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.
Posted
Mar 2010
Number
percentage of participants
Day 1 through 4 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
OG002
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.
Posted
Mar 2010
Number
percentage of participants
Day 1 through 4 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) 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 combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
OG002
13vPnC Dose 2
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.
Posted
Number
percentage of participants
Day 1 through 4 after each dose
ID
Title
Description
OG000
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
OG001
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
Units
Counts
Time Frame
Not provided
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 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
12
300
220
299
EG001
7vPnC Infant Series
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
10
303
225
300
EG002
13vPnC Post-Infant Series
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
21
300
13
299
EG003
7vPnC Post-Infant Series
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
23
303
25
300
EG004
13vPnC Toddler Dose
Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
3
300
152
289
EG005
7vPnC Toddler Dose
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
4
303
143
284
EG006
13vPnC 6-Month Follow-up
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
11
300
11
287
EG007
7vPnC 6-Month Follow-up
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
14
303
8
287
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Accidental exposure
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG0030 affected303 at risk
EG004
Acidosis
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Apnoeic attack
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Brain contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG0002 affected300 at risk
EG0014 affected303 at risk
EG0021 affected300 at risk
EG003
Bronchopneumonia
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Chemical poisoning
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Concussion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0021 affected300 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Croup infectious
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Cystitis
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Ear infection
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Enteritis infectious
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Epididymitis
Reproductive system and breast disorders
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Febrile convulsion
Nervous system disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Febrile infection
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
Non-systematic Assessment
EG0002 affected300 at risk
EG0012 affected303 at risk
EG0022 affected300 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected300 at risk
EG003
Intussusception
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Laceration
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Nicotine poisoning
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Otitis media
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Periorbital cellulitis
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Pharyngotonsillitis
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0021 affected300 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Pyelonephritis
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Pyelonephritis acute
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0012 affected303 at risk
EG0020 affected300 at risk
EG003
Rhinitis
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Rotavirus infection
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0022 affected300 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0011 affected303 at risk
EG0020 affected300 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0011 affected303 at risk
EG0020 affected300 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Viral infection
Infections and infestations
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0021 affected300 at risk
EG003
Viral tonsillitis
Infections and infestations
Non-systematic Assessment
EG0001 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Vitello-intestinal duct remnant
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected300 at risk
EG0010 affected303 at risk
EG0020 affected300 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG0031 affected300 at risk
EG0041 affected289 at risk
EG0051 affected284 at risk
EG0060 affected287 at risk
EG0070 affected287 at risk
Anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Congenital torticollis
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Craniotabes
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Hereditary fructose intolerance
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Macrocephaly
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Naevus flammeus
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Pectus excavatum
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Plagiocephaly
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Middle ear disorder
Ear and labyrinth disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Ear pain
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Otosalpingitis
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Conjunctivitis
Eye disorders
Non-systematic Assessment
EG00022 affected299 at risk
EG00125 affected300 at risk
EG0020 affected299 at risk
EG003
Dacryostenosis acquired
Eye disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Pupils unequal
Eye disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Dacryoadenitis acquired
Eye disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Eye inflammation
Eye disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Non-systematic Assessment
EG00021 affected299 at risk
EG00114 affected300 at risk
EG0020 affected299 at risk
EG003
Flatulence
Gastrointestinal disorders
Non-systematic Assessment
EG00011 affected299 at risk
EG0018 affected300 at risk
EG0020 affected299 at risk
EG003
Constipation
Gastrointestinal disorders
Non-systematic Assessment
EG00011 affected299 at risk
EG0016 affected300 at risk
EG0020 affected299 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG0008 affected299 at risk
EG0017 affected300 at risk
EG0020 affected299 at risk
EG003
Teething
Gastrointestinal disorders
Non-systematic Assessment
EG0006 affected299 at risk
EG0018 affected300 at risk
EG0020 affected299 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Non-systematic Assessment
EG0005 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Infantile colic
Gastrointestinal disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Dental discomfort
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Anal prolapse
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Enteritis
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Stomatitis
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG00029 affected299 at risk
EG00127 affected300 at risk
EG0020 affected299 at risk
EG003
Injection site swelling
General disorders
Non-systematic Assessment
EG0003 affected299 at risk
EG0014 affected300 at risk
EG0020 affected299 at risk
EG003
Injection site erythema
General disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Injection site induration
General disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Injection site pain
General disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Injection site reaction
General disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Injection site haematoma
General disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pain
General disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Hypersensitivity
Immune system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG00075 affected299 at risk
EG00164 affected300 at risk
EG0022 affected299 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG00049 affected299 at risk
EG00145 affected300 at risk
EG0022 affected299 at risk
EG003
Rhinitis
Infections and infestations
Non-systematic Assessment
EG00024 affected299 at risk
EG00132 affected300 at risk
EG0022 affected299 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG00019 affected299 at risk
EG00128 affected300 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG00021 affected299 at risk
EG00122 affected300 at risk
EG0020 affected299 at risk
EG003
Viral infection
Infections and infestations
Non-systematic Assessment
EG00011 affected299 at risk
EG00114 affected300 at risk
EG0020 affected299 at risk
EG003
Oral candidiasis
Infections and infestations
Non-systematic Assessment
EG0009 affected299 at risk
EG00112 affected300 at risk
EG0020 affected299 at risk
EG003
Otitis media
Infections and infestations
Non-systematic Assessment
EG0007 affected299 at risk
EG00113 affected300 at risk
EG0020 affected299 at risk
EG003
Febrile infection
Infections and infestations
Non-systematic Assessment
EG0007 affected299 at risk
EG00110 affected300 at risk
EG0020 affected299 at risk
EG003
Candida nappy rash
Infections and infestations
Non-systematic Assessment
EG0004 affected299 at risk
EG0015 affected300 at risk
EG0020 affected299 at risk
EG003
Respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0006 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Enteritis infectious
Infections and infestations
Non-systematic Assessment
EG0003 affected299 at risk
EG0015 affected300 at risk
EG0020 affected299 at risk
EG003
Exanthema subitum
Infections and infestations
Non-systematic Assessment
EG0004 affected299 at risk
EG0014 affected300 at risk
EG0020 affected299 at risk
EG003
Influenza
Infections and infestations
Non-systematic Assessment
EG0002 affected299 at risk
EG0014 affected300 at risk
EG0020 affected299 at risk
EG003
Candidiasis
Infections and infestations
Non-systematic Assessment
EG0002 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Ear infection
Infections and infestations
Non-systematic Assessment
EG0003 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Pharyngitis
Infections and infestations
Non-systematic Assessment
EG0002 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Skin candida
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Varicella
Infections and infestations
Non-systematic Assessment
EG0003 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Bacterial infection
Infections and infestations
Non-systematic Assessment
EG0002 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0002 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Genital candidiasis
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Oral fungal infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Paronychia
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Respiratory tract infection viral
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Viral rash
Infections and infestations
Non-systematic Assessment
EG0002 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Abscess
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Bacterial rhinitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Bronchitis bacterial
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Conjunctivitis infective
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Croup infectious
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Eczema infected
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Folliculitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Fungal skin infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Gastrointestinal infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Otitis media acute
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Otitis media viral
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pertussis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Postoperative wound infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pseudocroup
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Scarlet fever
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Sinobronchitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Tinea infection
Infections and infestations
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Tonsillitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Tracheitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Viral diarrhoea
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Viral rhinitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0003 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected299 at risk
EG0012 affected300 at risk
EG0021 affected299 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Concussion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Weight decreased
Investigations
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Feeding disorder neonatal
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Acidosis
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Obesity
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Oral intake reduced
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Posture abnormal
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Head deformity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Hypotonia neonatal
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Coordination abnormal
Nervous system disorders
Non-systematic Assessment
EG0003 affected299 at risk
EG0017 affected300 at risk
EG0020 affected299 at risk
EG003
Hypotonia
Nervous system disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Hypersomnia
Nervous system disorders
Non-systematic Assessment
EG0003 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Hypertonia
Nervous system disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Hypokinesia
Nervous system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
High-pitched crying
Nervous system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Myotonia
Nervous system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Poor quality sleep
Nervous system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Somnolence
Nervous system disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Crying
Psychiatric disorders
Non-systematic Assessment
EG00011 affected299 at risk
EG00110 affected300 at risk
EG0020 affected299 at risk
EG003
Restlessness
Psychiatric disorders
Non-systematic Assessment
EG0007 affected299 at risk
EG00114 affected300 at risk
EG0020 affected299 at risk
EG003
Agitation
Psychiatric disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Insomnia
Psychiatric disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
Non-systematic Assessment
EG0005 affected299 at risk
EG0017 affected300 at risk
EG0020 affected299 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00012 affected299 at risk
EG0017 affected300 at risk
EG0020 affected299 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Supraclavicular retraction
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00022 affected299 at risk
EG00125 affected300 at risk
EG0020 affected299 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00010 affected299 at risk
EG00114 affected300 at risk
EG0022 affected299 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0006 affected299 at risk
EG0016 affected300 at risk
EG0021 affected299 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0007 affected299 at risk
EG0015 affected300 at risk
EG0020 affected299 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0004 affected299 at risk
EG0015 affected300 at risk
EG0020 affected299 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0003 affected299 at risk
EG0014 affected300 at risk
EG0020 affected299 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0015 affected300 at risk
EG0020 affected299 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0002 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0013 affected300 at risk
EG0020 affected299 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0003 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0012 affected300 at risk
EG0020 affected299 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Rash neonatal
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0011 affected300 at risk
EG0020 affected299 at risk
EG003
Mastocytosis
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0021 affected299 at risk
EG003
Eyelid disorder
Eye disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Atopy
Immune system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Salmonellosis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0021 affected299 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Ocular hyperaemia
Eye disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Cheilitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Irritability
General disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Granuloma
General disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Acute tonsillitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Bronchitis viral
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Bronchopneumonia
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Fungal infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Gastroenteritis viral
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Herpes virus infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Lower respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Omphalitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Otitis externa
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Rhinolaryngitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Rotavirus infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Tracheobronchitis
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Viral skin infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Accidental exposure
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Laceration
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Fine motor delay
Nervous system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Pseudoparalysis
Nervous system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Screaming
Psychiatric disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Urinary tract disorder
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Balanitis
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
21-hydroxylase deficiency
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Strabismus
Eye disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Drug hypersensitivity
Immune system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Cardiac murmur
Investigations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Blood immunoglobulin e increased
Investigations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Tonsillar disorder
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Hypermetropia
Eye disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Developmental delay
General disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0021 affected299 at risk
EG003
Wound infection
Infections and infestations
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Sleep disorder
Psychiatric disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0021 affected299 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Food allergy
Immune system disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Hyperphosphatasaemia
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected299 at risk
EG0010 affected300 at risk
EG0020 affected299 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (Any)
EG00088 affected267 at risk
EG00187 affected267 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (Any)
EG00073 affected250 at risk
EG00176 affected241 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (Any)
EG00062 affected229 at risk
EG00147 affected221 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactionss
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (Significant)
EG00020 affected260 at risk
EG00118 affected258 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (Significant)
EG00011 affected236 at risk
EG00117 affected226 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (Significant)
EG0009 affected215 at risk
EG0016 affected209 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)
EG00075 affected266 at risk
EG00154 affected263 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (Any)
EG00065 affected244 at risk
EG00185 affected242 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (Any)
EG00059 affected226 at risk
EG00164 affected224 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)
EG00065 affected265 at risk
EG00150 affected263 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (Mild)
EG00059 affected243 at risk
EG00180 affected239 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (Mild)
EG00056 affected226 at risk
EG00162 affected223 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (Moderate)
EG00019 affected261 at risk
EG00115 affected256 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (Moderate)
EG00018 affected235 at risk
EG00115 affected227 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (Moderate)
EG00015 affected217 at risk
EG00111 affected211 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)
EG0000 affected259 at risk
EG0010 affected255 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 affected232 at risk
EG0010 affected223 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 affected214 at risk
EG0010 affected208 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)
EG00075 affected266 at risk
EG00199 affected272 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (Any)
EG00085 affected247 at risk
EG001118 affected252 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (Any)
EG00083 affected238 at risk
EG00192 affected231 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)
EG00072 affected265 at risk
EG00198 affected271 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (Mild)
EG00083 affected247 at risk
EG001114 affected250 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (Mild)
EG00081 affected237 at risk
EG00189 affected229 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)
EG0005 affected260 at risk
EG0014 affected256 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (Moderate)
EG0004 affected232 at risk
EG0018 affected224 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (Moderate)
EG00010 affected217 at risk
EG0015 affected210 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)
EG0000 affected259 at risk
EG0010 affected255 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 affected232 at risk
EG0010 affected222 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 affected214 at risk
EG0010 affected208 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°C but ≤39°C
EG000117 affected269 at risk
EG001103 affected266 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°C but ≤39°C
EG000116 affected248 at risk
EG001121 affected250 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°C but ≤39°C
EG000112 affected242 at risk
EG00185 affected232 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°C but ≤40°C
EG00011 affected260 at risk
EG0014 affected256 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >39°C but ≤40°C
EG00021 affected238 at risk
EG00110 affected225 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°C but ≤40°C
EG0008 affected216 at risk
EG0013 affected210 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°C
EG0000 affected259 at risk
EG0010 affected256 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >40°C
EG0000 affected233 at risk
EG0010 affected223 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever >40°C
EG0002 affected216 at risk
EG0010 affected209 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG00089 affected269 at risk
EG00181 affected267 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG00084 affected249 at risk
EG00184 affected245 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00078 affected236 at risk
EG00168 affected225 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG000117 affected275 at risk
EG001120 affected266 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG000120 affected254 at risk
EG001139 affected252 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Irritability
EG000108 affected238 at risk
EG001115 affected235 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG000175 affected284 at risk
EG001160 affected272 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG000139 affected258 at risk
EG001171 affected256 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG000119 affected240 at risk
EG001119 affected241 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG00067 affected266 at risk
EG00169 affected264 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00057 affected240 at risk
EG00154 affected234 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00048 affected230 at risk
EG00154 affected221 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
Ancestor Terms
ID
Term
D022242
Pneumococcal Vaccines
D022541
Streptococcal Vaccines
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D017778
Vaccines, Combined
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
Protocol Violation
FG0002 subjects
FG0012 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
1 subjects
278
Male
BG000150
BG001176
BG002326
77.5
(72.2 to 82.2)
OG00187.1(82.5 to 90.8)
Common Serotypes-Serotype 9V
Title
Measurements
OG00098.6(96.4 to 99.6)
OG00196.4(93.5 to 98.3)
Common Serotypes-Serotype 14
Title
Measurements
OG00098.9(96.9 to 99.8)
OG00197.5(94.9 to 99.0)
Common Serotypes-Serotype 18C
Title
Measurements
OG00097.2(94.5 to 98.8)
OG00198.6(96.3 to 99.6)
Common Serotypes-Serotype 19F
Title
Measurements
OG00095.8(92.7 to 97.8)
OG00196.0(93.0 to 98.0)
Common Serotypes-Serotype 23F
Title
Measurements
OG00088.7(84.5 to 92.2)
OG00189.5(85.3 to 92.9)
Additional Serotypes-Serotype 1
Title
Measurements
OG00096.1(93.2 to 98.1)
OG0011.4(0.4 to 3.7)
Additional Serotypes-Serotype 3
Title
Measurements
OG00098.2(95.9 to 99.4)
OG0016.3(3.7 to 9.8)
Additional Serotypes-Serotype 5
Title
Measurements
OG00093.0(89.3 to 95.6)
OG00131.6(25.8 to 37.8)
Additional Serotypes-Serotype 6A
Title
Measurements
OG00091.9(88.1 to 94.8)
OG00131.6(26.1 to 37.5)
Additional Serotypes-Serotype 7F
Title
Measurements
OG00098.6(96.4 to 99.6)
OG0014.0(2.0 to 7.0)
Additional Serotypes-Serotype 19A
Title
Measurements
OG00099.3(97.5 to 99.9)
OG00179.2(73.8 to 83.9)
OG000
OG001
For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Difference
-9.6
2-Sided
95
-16.0
-3.3
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest 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
2.2
2-Sided
95
-0.4
5.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest 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
1.5
2-Sided
95
-0.9
4.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest 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
-1.4
2-Sided
95
-4.2
1.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest 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
-0.3
2-Sided
95
-3.8
3.3
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest 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
-0.8
2-Sided
95
-6.0
4.5
Yes
Non-Inferiority or Equivalence
Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Units
Counts
Participants
OG000285
OG001279
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG0002.18(1.98 to 2.40)
OG0012.99(2.68 to 3.33)
Common Serotypes - Serotype 6B
Title
Measurements
OG0000.98(0.84 to 1.14)
OG0011.49(1.27 to 1.75)
Common Serotypes - Serotype 9V
Title
Measurements
OG0001.65(1.51 to 1.80)
OG0011.96(1.77 to 2.17)
Common Serotypes - Serotype 14
Title
Measurements
OG0004.14(3.68 to 4.66)
OG0014.61(4.07 to 5.23)
Common Serotypes - Serotype 18C
Title
Measurements
OG0001.94(1.76 to 2.14)
OG0012.25(2.04 to 2.49)
Common Serotypes - Serotype 19F
Title
Measurements
OG0001.73(1.56 to 1.92)
OG0012.86(2.53 to 3.24)
Common Serotypes - Serotype 23F
Title
Measurements
OG0001.26(1.11 to 1.43)
OG0011.44(1.25 to 1.65)
Additional Serotypes - Serotype 1
Title
Measurements
OG0001.83(1.64 to 2.04)
OG0010.03(0.02 to 0.03)
Additional Serotypes - Serotype 3
Title
Measurements
OG0001.55(1.41 to 1.72)
OG0010.05(0.04 to 0.06)
Additional Serotypes - Serotype 5
Title
Measurements
OG0001.31(1.17 to 1.46)
OG0010.20(0.18 to 0.23)
Additional Serotypes - Serotype 6A
Title
Measurements
OG0001.33(1.18 to 1.49)
OG0010.23(0.20 to 0.26)
Additional Serotypes - Serotype 7F
Title
Measurements
OG0002.59(2.36 to 2.85)
OG0010.04(0.04 to 0.05)
Additional Serotypes - Serotype 19A
Title
Measurements
OG0003.26(2.97 to 3.59)
OG0010.64(0.58 to 0.71)
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
0.73
2-Sided
95
0.63
0.84
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
0.65
2-Sided
95
0.52
0.82
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
0.84
2-Sided
95
0.74
0.96
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
0.90
2-Sided
95
0.76
1.07
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
2.25
2-Sided
95
2.04
2.49
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
0.60
2-Sided
95
0.51
0.71
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
0.88
2-Sided
95
0.73
1.06
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).
Units
Counts
Participants
OG000285
OG001279
Title
Denominators
Categories
Common Serotypes - Serotype 4 (n=92,94)
Title
Measurements
OG000100.0(96.1 to 100.0)
OG001100.0(96.2 to 100.0)
Common Serotypes - Serotype 6B (n=100,94)
Title
Measurements
OG00096.0(90.1 to 98.9)
OG00198.9(94.2 to 100.0)
Common Serotypes - Serotype 9V (n=89,89)
Title
Measurements
OG000100.0(95.9 to 100.0)
OG001100.0(95.9 to 100.0)
Common Serotypes - Serotype 14 (n=95,89)
Title
Measurements
OG000100.0(96.2 to 100.0)
OG001100.0(95.9 to 100.0)
Common Serotypes - Serotype 18C (n=100,94)
Title
Measurements
OG000100.0(96.4 to 100.0)
OG00198.9(94.2 to 100.0)
Common Serotypes - Serotype 19F (n=100,94)
Title
Measurements
OG00096.0(90.1 to 98.9)
OG00193.6(86.6 to 97.6)
Common Serotypes - Serotype 23F (n=100,93)
Title
Measurements
OG00096.0(90.1 to 98.9)
OG00195.7(89.4 to 98.8)
Additional Serotypes - Serotype 1 (n=100,92)
Title
Measurements
OG00093.0(86.1 to 97.1)
OG0014.3(1.2 to 10.8)
Additional Serotypes - Serotype 3 (n=100,94)
Title
Measurements
OG00099.0(94.6 to 100.0)
OG00124.5(16.2 to 34.4)
Additional Serotypes - Serotype 5 (n=100,94)
Title
Measurements
OG00099.0(94.6 to 100.0)
OG0014.3(1.2 to 10.5)
Additional Serotypes - Serotype 6A (n=99,93)
Title
Measurements
OG00096.0(90.0 to 98.9)
OG00172.0(61.8 to 80.9)
Additional Serotypes - Serotype 7F (n=99,94)
Title
Measurements
OG000100.0(96.3 to 100.0)
OG00178.7(69.1 to 86.5)
Additional Serotypes - Serotype 19A (n=95,94)
Title
Measurements
OG000100.00(96.2 to 100.0)
OG00117.0(10.1 to 26.2)
Units
Counts
Participants
OG000285
OG001279
Title
Denominators
Categories
Common Serotypes -Serotype 4 (n=92,94)
Title
Measurements
OG0001573.29(1283.03 to 1929.21)
OG0011860.79(1540.00 to 2248.41)
Common Serotypes - Serotype 6B (n=100,94)
Title
Measurements
OG000744.43(556.91 to 995.11)
OG0011160.76(921.46 to 1462.19)
Common Serotypes - Serotype 9V (n=89,89)
Title
Measurements
OG0004937.84(3614.78 to 6745.14)
OG0015379.51(3935.51 to 7353.34)
Common Serotypes - Serotype 14 (n=95,89)
Title
Measurements
OG0002139.65(1570.10 to 2915.79)
OG0013345.19(2473.27 to 4524.50)
Common Serotypes - Serotype 18C (n=100,94)
Title
Measurements
OG0001509.65(1243.64 to 1832.56)
OG0011780.26(1382.42 to 2292.59)
Common Serotypes - Serotype 19F (n=100,94)
Title
Measurements
OG000150.12(116.89 to 192.81)
OG001165.69(122.98 to 223.23)
Common Serotypes - Serotype 23F (n=100,93)
Title
Measurements
OG0001089.92(795.20 to 1493.86)
OG0011070.83(786.59 to 1457.78)
Additional Serotypes - Serotype 1 (n=100,92)
Title
Measurements
OG00050.21(39.39 to 64.02)
OG0014.15(3.99 to 4.32)
Additional Serotypes - Serotype 3 (n=100,94)
Title
Measurements
OG000250.73(205.52 to 305.89)
OG0016.13(5.17 to 7.28)
Additional Serotypes - Serotype 5 (n=100,94)
Title
Measurements
OG000162.02(126.31 to 207.82)
OG0014.64(3.96 to 5.43)
Additional Serotypes - Serotype 6A (n=99,93)
Title
Measurements
OG0001228.45(883.49 to 1708.11)
OG001122.40(74.09 to 202.21)
Additional Serotypes - Serotype 7F (n=99,94)
Title
Measurements
OG00011544.75(9364.02 to 14233.34)
OG001115.45(75.16 to 177.32)
Additional Serotypes - Serotype 19A (n=95,94)
Title
Measurements
OG000442.48(360.53 to 543.06)
OG0016.70(5.19 to 8.66)
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
OG003
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Units
Counts
Participants
OG000267
OG001252
OG002252
OG003242
Title
Denominators
Categories
Haemophilus influenzae type b 0.15 µg/mL threshold
Title
Measurements
OG00089.5(85.2 to 92.9)
OG00186.9(82.1 to 90.8)
OG002100.0(98.5 to 100.0)
OG003100.0(98.5 to 100.0)
Haemophilus influenzae type b 1.0 µg/mL threshold
Title
Measurements
OG00058.4(52.3 to 64.4)
OG00154.0(47.6 to 60.2)
OG00299.6(97.8 to 100.0)
OG003
Diphtheria toxoid at 0.01 IU/mL threshold
Title
Measurements
OG000100.0(98.7 to 100.0)
OG001100.0(98.6 to 100.0)
OG002100.0(98.6 to 100.0)
OG003
Diphtheria toxoid at 0.1 IU/mL threshold
Title
Measurements
OG00089.7(85.5 to 93.0)
OG00194.2(90.6 to 96.7)
OG002100.0(98.6 to 100.0)
OG003
Hepatitis B at ≥ 10.0 mIU/mL
Title
Measurements
OG00094.9(91.7 to 97.2)
OG00196.3(93.2 to 98.2)
OG00299.3(97.4 to 99.9)
OG003
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 0.15 µg/mL threshold was calculated
Difference
2.6
2-Sided
95
-3.0
8.3
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 percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Difference
4.5
2-Sided
95
-4.1
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%.
OG000
OG001
For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated
Difference
0.0
95
-1.4
1.5
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) > -10%.
OG000
OG001
For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated
Difference
-4.5
95
-9.3
0.3
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%.
OG002
OG003
For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated
Difference
0.0
2-Sided
95
-1.5
1.5
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) > -10%.
OG000
OG001
For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated
Difference
-1.3
95
-5.0
2.3
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%.
OG002
OG003
For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Difference
1.7
2-Sided
95
-0.4
4.4
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) > -10%.
OG002
OG003
For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated
Difference
0.0
95
-1.4
1.4
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) > -10%.
OG002
OG003
For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated
Difference
0.0
95
-1.4
1.4
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) > -10%.
OG002
OG003
For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated
Difference
0.8
95
-1.3
3.3
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%.
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
OG003
7vPnC AfterToddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Units
Counts
Participants
OG000267
OG001252
OG002285
OG003279
Title
Denominators
Categories
Title
Measurements
OG0001.23(1.03 to 1.46)
OG0011.00(0.83 to 1.20)
OG00211.79(10.36 to 13.41)
OG00310.24(8.88 to 11.82)
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 GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.23
2-Sided
95
0.96
1.58
Yes
Non-Inferiority or Equivalence
Non-inferiority for the 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
OG003
For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.15
2-Sided
95
0.95
1.39
Yes
Non-Inferiority or Equivalence
Non-inferiority for the 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).
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
OG003
7vPnC AfterToddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Units
Counts
Participants
OG000272
OG001258
OG002285
OG003279
Title
Denominators
Categories
Title
Measurements
OG0000.36(0.32 to 0.41)
OG0010.53(0.47 to 0.60)
OG0022.67(2.44 to 2.93)
OG0033.08(2.74 to 3.47)
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 diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.68
2-Sided
95
0.57
0.80
Yes
Non-Inferiority or Equivalence
Non-inferiority for the 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
OG003
For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.87
2-Sided
95
0.75
1.01
Yes
Non-Inferiority or Equivalence
Non-inferiority for the 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 AfterToddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
OG003
7vPnC AfterToddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Units
Counts
Participants
OG000277
OG001268
OG002285
OG003279
Title
Denominators
Categories
Title
Measurements
OG000145.19(122.62 to 171.92)
OG001165.25(140.33 to 194.61)
OG0021118.05(935.26 to 1336.56)
OG0031195.82(976.12 to 1464.98)
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 hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.
Ratio
0.88
2-Sided
95
0.69
1.11
Yes
Non-Inferiority or Equivalence
Non-inferiority for the 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
OG003
For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.93
2-Sided
95
0.71
1.22
Yes
Non-Inferiority or Equivalence
Non-inferiority for the 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 After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
OG003
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Units
Counts
Participants
OG000285
OG001279
OG002285
OG003279
Title
Denominators
Categories
Common Serotypes -Serotype 4 (n=277,264,276,263)
Title
Measurements
OG0000.46(0.42 to 0.51)
OG0010.58(0.53 to 0.64)
OG0024.16(3.75 to 4.62)
OG0035.07(4.53 to 5.67)
Common Serotypes - Serotype 6B (n=275,261,273,251)
Title
Measurements
OG0000.97(0.87 to 1.07)
OG0011.06(0.94 to 1.20)
OG0029.14(8.14 to 10.26)
OG003
Common Serotypes - Serotype 9V (n=277,265,277,262)
Title
Measurements
OG0000.46(0.42 to 0.50)
OG0010.52(0.48 to 0.57)
OG0022.75(2.52 to 2.99)
OG003
Common Serotypes - Serotype 14 (n=273,263,276,260)
Title
Measurements
OG0002.20(1.96 to 2.48)
OG0012.65(2.34 to 3.00)
OG0028.34(7.50 to 9.28)
OG003
Common Serotypes-Serotype 18C (n=277,265,276,263)
Title
Measurements
OG0000.33(0.30 to 0.36)
OG0010.39(0.36 to 0.43)
OG0022.79(2.53 to 3.07)
OG003
Common Serotypes-Serotype 19F (n=276,264,276,263)
Title
Measurements
OG0000.68(0.60 to 0.76)
OG0010.58(0.52 to 0.66)
OG0025.99(5.36 to 6.68)
OG003
Common Serotypes-Serotype 23F (n=275,264,277,264)
Title
Measurements
OG0000.33(0.30 to 0.37)
OG0010.39(0.34 to 0.45)
OG0023.36(2.98 to 3.78)
OG003
Additional - Serotype 1 (n=277,264,278,257)
Title
Measurements
OG0000.52(0.48 to 0.57)
OG0010.03(0.02 to 0.03)
OG0024.25(3.80 to 4.75)
OG003
Additional - Serotype 3 (n=275,264,278,255)
Title
Measurements
OG0000.25(0.23 to 0.28)
OG0010.05(0.05 to 0.06)
OG0021.02(0.92 to 1.13)
OG003
Additional - Serotype 5 (n=275,264,276,220)
Title
Measurements
OG0000.74(0.67 to 0.81)
OG0010.34(0.30 to 0.39)
OG0023.56(3.25 to 3.89)
OG003
Additional - Serotype 6A (n=276,264,274,255)
Title
Measurements
OG0000.76(0.68 to 0.85)
OG0010.33(0.29 to 0.37)
OG0025.88(5.24 to 6.59)
OG003
Additional - Serotype 7F (n=277,264,278,263)
Title
Measurements
OG0000.99(0.91 to 1.08)
OG0010.04(0.04 to 0.04)
OG0024.79(4.29 to 5.34)
OG003
Additional - Serotype 19A (n=277,264,271,260)
Title
Measurements
OG0001.28(1.14 to 1.45)
OG0010.72(0.65 to 0.80)
OG0029.58(8.68 to 10.58)
OG003
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
OG004
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
OG005
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
OG006
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
OG007
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
OG004
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
OG005
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
Units
Counts
Participants
OG000300
OG001303
OG002296
OG003297
OG004294
OG005293
Title
Denominators
Categories
Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232)
Title
Measurements
OG00043.5
OG00138.7
OG00246.8
OG00348.4
OG00446.3
OG00536.6
Fever >39°C but ≤40°C (n=260,256,238,225,216,210)