Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Official Title
Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Jan 2014
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
Dec 2004
Primary Completion Date
Mar 2006Actual
Completion Date
Oct 2007Actual
First Submitted Date
Mar 24, 2008
First Submission Date that Met QC Criteria
Mar 25, 2008
First Posted Date
Mar 26, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 24, 2009
Results First Submitted that Met QC Criteria
Dec 4, 2009
Results First Posted Date
Jan 8, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 21, 2014
Last Update Posted Date
Feb 14, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.
Primary Objective:
To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to <6 years of age.
Detailed Description
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.
Conditions Module
Conditions
Meningitis
Meningococcal Infection
Keywords
Meningitis; Meningococcal Infection
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
378Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Vaccinated at Age 9 and 12 Months
Experimental
Participants received Menactra® vaccine at 9 and 12 Months of age
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 9 and 15 Months
Experimental
Participants received Menactra® vaccine at 9 and 15 Months of age
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 12 and 15 Months
Experimental
Participants received Menactra® vaccine at Age 12 and 12 Months of age
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 15 Months
Experimental
Participants received Menactra® vaccine at 15 Months of age
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Vaccinated at Age 18 Months
Experimental
Participants received Menactra® vaccine at 18 Months of age
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Biological
0.5 mL, Intramuscular (at age 9 and 12 months)
Vaccinated at Age 9 and 12 Months
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
Secondary Outcomes
Not provided
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Day 0 up to 7 post-vaccination
Eligibility Module
Eligibility Criteria
Inclusion Criteria :
Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria :
History of a serious chronic disease that could interfere with trial conduct or completion.
Known or suspected impairment of immunologic function.
Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
Unable to attend one or more of the scheduled visits or to comply with the study procedures.
Participation in another clinical trial in the 4 weeks preceding enrollment.
Planned participation in another clinical trial during the present trial period.
Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Vaccinated at Age 3 Years to <6 Years
Menomune®
Norwich
Connecticut
06360
United States
Atlanta
Georgia
30322
United States
Marietta
Georgia
30062
United States
Bardstown
Kentucky
40004
United States
Baltimore
Maryland
21201
United States
Woburn
Massachusetts
01801
United States
Akron
Ohio
44308
United States
Columbus
Ohio
43205
United States
Drexel Hill
Pennsylvania
19026
United States
Pittsburgh
Pennsylvania
15241
United States
Sellersville
Pennsylvania
18960
United States
Kingsport
Tennessee
37664
United States
Salt Lake City
Utah
84123
United States
FG002
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
FG003
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
FG004
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
FG005
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to <6 years of age
FG00055 subjects
FG00167 subjects
FG00268 subjects
FG00362 subjects
FG00459 subjects
FG00567 subjects
COMPLETED
FG00051 subjects
FG00161 subjects
FG00262 subjects
FG00360 subjects
FG00457 subjects
FG00566 subjects
NOT COMPLETED
FG0004 subjects
FG0016 subjects
FG0026 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Not Vaccinated
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Vaccinated at Age 9 and 12 Months
Participants received Menactra vaccine at 9 and 12 months of age
BG001
Vaccinated at Age 9 and 15 Months
Participants received Menactra vaccine at 9 months and 15 months of age
BG002
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
BG003
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
BG004
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
BG005
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to <6 years of age
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00055
BG00167
BG00268
BG00362
BG00459
BG00567
BG006378
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG00055
BG00167
BG00268
BG003
Age, Continuous
Mean
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG0008.9± 0.4
BG0018.9± 0.3
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00134
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00055
BG00167
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 With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Posted
Number
Percentage of Participants
Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
ID
Title
Description
OG000
Vaccinated at Age 9 and 12 Months
Participants received Menactra vaccine at 9 and 12 months of age
OG001
Vaccinated at Age 9 and 15 Months
Participants received Menactra vaccine at 9 months and 15 months of age
OG002
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
OG003
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
OG004
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
OG005
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to <6 years of age
Units
Counts
Participants
OG00040
OG00150
OG00254
OG003
Title
Denominators
Categories
Meningococcal serogroup A (Baseline)
Title
Measurements
OG00038
OG00144
OG00233
OG003
Other Pre-specified
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.
Posted
Number
Percentage of participants
Day 0 up to 7 post-vaccination
ID
Title
Description
OG000
Vaccinated at Age 9 and 12 Months
Participants received Menactra vaccine at 9 and 12 months of age
OG001
Vaccinated at Age 9 and 15 Months
Participants received Menactra vaccine at 9 months and 15 months of age
OG002
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
OG003
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
Time Frame
Adverse events data were collected for 6 months post-vaccination.
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
Vaccinated at Age 9 and 12 Months
Participants received Menactra vaccine at 9 and 12 months of age
0
53
37
53
EG001
Vaccinated at Age 9 and 15 Months
Participants received Menactra vaccine at 9 months and 15 months of age
3
65
50
65
EG002
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
4
65
48
65
EG003
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
1
61
34
61
EG004
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
5
57
33
57
EG005
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to <6 years of age
3
67
21
67
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Granulocytopenia
Blood and lymphatic system disorders
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected65 at risk
EG0030 events0 affected61 at risk
EG0040 events0 affected57 at risk
EG0050 events0 affected67 at risk
Appendicitis perforated
Gastrointestinal disorders
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Abscess
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected65 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected65 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected65 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected65 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Pneumonia adenoviral
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Conjunctivitis
Eye disorders
MedDRA 7.1
Non-systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events3 affected65 at risk
EG0022 events2 affected65 at risk
EG0033 events3 affected61 at risk
EG0044 events3 affected57 at risk
EG0051 events1 affected67 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 7.1
Non-systematic Assessment
EG00012 events9 affected53 at risk
EG00118 events13 affected65 at risk
EG0029 events8 affected65 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA 7.1
Non-systematic Assessment
EG00010 events8 affected53 at risk
EG00122 events13 affected65 at risk
EG00223 events17 affected65 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 7.1
Non-systematic Assessment
EG0003 events3 affected53 at risk
EG0015 events4 affected65 at risk
EG0023 events3 affected65 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 7.1
Non-systematic Assessment
EG0003 events3 affected53 at risk
EG0019 events9 affected65 at risk
EG0029 events7 affected65 at risk
EG003
Pyrexia
General disorders
MedDRA 7.1
Non-systematic Assessment
EG0006 events6 affected53 at risk
EG00116 events13 affected65 at risk
EG0028 events7 affected65 at risk
EG003
Otitis media
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0003 events3 affected53 at risk
EG00115 events13 affected65 at risk
EG0026 events6 affected65 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0003 events3 affected53 at risk
EG0013 events3 affected65 at risk
EG0023 events3 affected65 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0002 events2 affected53 at risk
EG0012 events2 affected65 at risk
EG0023 events3 affected65 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected65 at risk
EG0024 events4 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 7.1
Non-systematic Assessment
EG0006 events6 affected53 at risk
EG00113 events13 affected65 at risk
EG0029 events8 affected65 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Non-systematic Assessment
EG00015 events13 affected53 at risk
EG00114 events12 affected65 at risk
EG00216 events12 affected65 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Non-systematic Assessment
EG0007 events6 affected53 at risk
EG0017 events7 affected65 at risk
EG0028 events5 affected65 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Non-systematic Assessment
EG0009 events7 affected53 at risk
EG0016 events6 affected65 at risk
EG00212 events10 affected65 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected65 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 7.1
Non-systematic Assessment
EG0001 events1 affected53 at risk
EG0016 events6 affected65 at risk
EG0024 events3 affected65 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 7.1
Non-systematic Assessment
EG0004 events4 affected53 at risk
EG0013 events3 affected65 at risk
EG0024 events4 affected65 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
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com
ID
Term
D008581
Meningitis
D008589
Meningococcal Infections
Ancestor Terms
ID
Term
D000090862
Neuroinflammatory Diseases
D009422
Nervous System Diseases
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D022401
Meningococcal Vaccines
Ancestor Terms
ID
Term
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0051 subjects
2 subjects
FG0050 subjects
62
BG00459
BG00567
BG006378
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
11.9
± 0.3
BG00314.9± 0.3
BG00417.9± 0.3
BG00548.0± 10.3
BG00618.7± 14.6
34
BG00323
BG00434
BG00530
BG006179
Male
BG00031
BG00133
BG00234
BG00339
BG00425
BG00537
BG006199
68
BG00362
BG00459
BG00567
BG006378
55
OG00451
OG00563
40
OG00440
OG00571
Meningococcal serogroup A (Post dose 1)
Title
Measurements
OG00076
OG00167
OG00252
OG00376
OG00465
OG00587
Meningococcal serogroup A (Post dose 2)
Title
Measurements
OG00089
OG00189
OG00285
OG0030
OG0040
OG0050
Meningococcal serogroup C (Baseline)
Title
Measurements
OG0005
OG0012
OG0020
OG0032
OG0044
OG0058
Meningococcal serogroup C (Post dose 1)
Title
Measurements
OG00083
OG00185
OG00285
OG00386
OG00477
OG00549
Meningococcal serogroup C (Post dose 2)
Title
Measurements
OG000100
OG001100
OG002100
OG0030
OG0040
OG0050
Meningococcal serogroup Y (Baseline)
Title
Measurements
OG0003
OG0010
OG0022
OG0032
OG0048
OG0058
Meningococcal serogroup Y (Post dose 1)
Title
Measurements
OG00021
OG00124
OG00235
OG00333
OG00447
OG00566
Meningococcal serogroup Y (Post dose 2)
Title
Measurements
OG00095
OG00194
OG00296
OG0030
OG0040
OG0050
Meningococcal serogroup W-135 (Baseline)
Title
Measurements
OG0003
OG0010
OG0020
OG0032
OG0040
OG00510
Meningococcal serogroup W-135 (Post dose 1)
Title
Measurements
OG00024
OG00127
OG00218
OG00342
OG00436
OG00561
Meningococcal serogroup W-135 (Post dose 2)
Title
Measurements
OG00092
OG00192
OG00296
OG0030
OG0040
OG0050
OG004
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
OG005
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to <6 years of age
Units
Counts
Participants
OG00053
OG00165
OG00265
OG00362
OG00457
OG00567
Title
Denominators
Categories
Any Solicited Injection Site Reaction-Any Dose
Title
Measurements
OG00074
OG00169
OG00265
OG00353
OG00461
OG00555
Any Solicited Injection Site Reaction - Dose 1
Title
Measurements
OG00062
OG00145
OG00257
OG003
Grade 3 Solicited Injection Site Reaction - Dose 1
Title
Measurements
OG0000
OG0012
OG0022
OG003
Any Erythema
Title
Measurements
OG00032
OG00120
OG00234
OG003
Grade 3 Erythema (≥ 2 inches)
Title
Measurements
OG0000
OG0012
OG0022
OG003
Any Swelling
Title
Measurements
OG00023
OG0018
OG00215
OG003
Grade 3 Swelling (≥ 2 inches)
Title
Measurements
OG0000
OG0010
OG0022
OG003
Any Tenderness
Title
Measurements
OG00043
OG00131
OG00237
OG003
Grade 3 Tenderness (cries when inj. limb is moved)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any Solicited Systemic Reaction-Any Dose
Title
Measurements
OG00089
OG00184
OG00272
OG003
Any Solicited Systemic Reaction Dose 1
Title
Measurements
OG00072
OG00175
OG00260
OG003
Grade 3 Solicited Systemic Reaction Dose 1
Title
Measurements
OG0009
OG0018
OG0025
OG003
Any Fever
Title
Measurements
OG00023
OG00117
OG00211
OG003
Grade 3 Fever (≥ 39.6 ºC)
Title
Measurements
OG0002
OG0013
OG0020
OG003
Any Vomiting
Title
Measurements
OG00017
OG00120
OG00211
OG003
Grade 3 Vomiting (≥ 6 episodes per day)
Title
Measurements
OG0004
OG0010
OG0020
OG003
Any Crying Abnormal
Title
Measurements
OG00034
OG00136
OG00228
OG003
Grade 3 Crying Abnormal (> 3 hours)
Title
Measurements
OG0004
OG0013
OG0022
OG003
Any Drowsiness
Title
Measurements
OG00040
OG00138
OG00231
OG003
Grade 3 Drowsiness (difficulty to wake up)
Title
Measurements
OG0004
OG0010
OG0020
OG003
Any Appetite Lost
Title
Measurements
OG00028
OG00136
OG00228
OG003
Grade 3 Appetite Lost (refuses ≥ 3 feeds)
Title
Measurements
OG0004
OG0012
OG0025
OG003
Any Irritability
Title
Measurements
OG00060
OG00161
OG00249
OG003
Grade 3 Irrtability (inconsolable)
Title
Measurements
OG0004
OG0015
OG0023
OG003
Any Solicited Injection Site Reaction - Dose 2
Title
Measurements
OG00063
OG00154
OG00248
OG003
Grade 3 Solicited Injection Site Reaction - Dose 2
Title
Measurements
OG0002
OG0017
OG0020
OG003
Any Erythema
Title
Measurements
OG00029
OG00136
OG00223
OG003
Grade 3 Erythema (≥ 2 inches)
Title
Measurements
OG0000
OG0012
OG0020
OG003
Any Swelling
Title
Measurements
OG00025
OG00120
OG00211
OG003
Grade 3 Swelling (≥ 2 inches)
Title
Measurements
OG0000
OG0013
OG0020
OG003
Any Tenderness
Title
Measurements
OG00052
OG00142
OG00237
OG003
Grade 3 Tenderness (cries when inj. limb is moved)