Study of the Safety and Immune Response of a Meningococca... | NCT00262028 | Trialant
NCT00262028
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Feb 11, 2016Estimated
Enrollment
910Actual
Phase
Phase 2
Conditions
Prevention of Meningococcal Disease
Interventions
MenACWY-CRM Vaccine
MenACWY-PS Vaccine
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00262028
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V59P8
Secondary IDs
Not provided
Brief Title
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Official Title
A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2016
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
Apr 2005
Primary Completion Date
Nov 2006Actual
Completion Date
Nov 2006Actual
First Submitted Date
Dec 2, 2005
First Submission Date that Met QC Criteria
Dec 2, 2005
First Posted Date
Dec 6, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 30, 2013
Results First Submitted that Met QC Criteria
Jan 12, 2016
Results First Posted Date
Feb 11, 2016Estimated
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 12, 2016
Last Update Posted Date
Feb 11, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years
Detailed Description
Not provided
Conditions Module
Conditions
Prevention of Meningococcal Disease
Keywords
Not provided
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
910Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MenACWY-CRM (2-10 years)
Experimental
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
Biological: MenACWY-CRM Vaccine
MenACWY-CRM (12-23 months)
Experimental
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
Biological: MenACWY-CRM Vaccine
MenACWY-PS (2-10 years)
Active Comparator
Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine
Biological: MenACWY-PS Vaccine
MenACWY-CRM+PnC (12-15 months)
Experimental
Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC
Biological: MenACWY-CRM Vaccine
MenACWY-CRM+DTaP (16-23 months)
Experimental
Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP
Biological: MenACWY-CRM Vaccine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MenACWY-CRM Vaccine
Biological
MenACWY-CRM (12-23 months)
MenACWY-CRM (2-10 years)
MenACWY-CRM+DTaP (16-23 months)
MenACWY-CRM+PnC (12-15 months)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
1 month post vaccination (Day 29)
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
1 month post vaccination (Day 29)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Group 1: Healthy children 2-10 years of age;
Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.
Exclusion Criteria:
Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Accepts Healthy Volunteers
Not provided
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Months
Maximum Age
10 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Vaccines
Novartis Vaccines & Diagnostics
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Kaiser Permanente Vaccine Study Center
Oakland
California
94612
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
All enrolled subjects participated in this study.
Recruitment Details
Subjects were recruited from a single center.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MenACWY (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
FG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
FG002
MenACWY (6-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
FG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
FG004
MenACWY (12-15 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
FG005
MenACWY+PnC (12-15 Months)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
FG006
MenACWY (16-23 Months)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
FG007
MenACWY+DTaP (16-23 Months)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
FG008
MenACWY-PS (3-5 Years Old)
Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000152 subjects
FG001153 subjects
FG002157 subjects
FG003157 subjects
FG00474 subjects
FG00573 subjects
FG00671 subjects
FG00773 subjects
FG008100 subjects
COMPLETED
FG000128 subjects
FG001126 subjects
FG002137 subjects
FG003134 subjects
FG004
NOT COMPLETED
FG00024 subjects
FG00127 subjects
FG00220 subjects
FG00323 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG0013 subjects
FG0026 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MenACWY (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
BG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.
Posted
Number
Subjects
1 month post vaccination (Day 29)
ID
Title
Description
OG000
MenACWY-CRM (2-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
Adverse Events Module
Frequency Threshold
5
Time Frame
Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
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
MenACWY (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
ID
Term
C556088
MenACWY-CRM vaccine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Not provided
MenACWY-PS Vaccine
Biological
MenACWY-PS (2-10 years)
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
1 month post vaccination (Day 29)
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
1 month post vaccination (Day 29)
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
1 month post vaccination (Day 29)
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
1 month post vaccination (Day 29)
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
12 months post vaccination (Day 360)
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
12 months post vaccination (Day 360)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Day 1 to 7 post vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Day 1 to 7 post vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Day 1- Day 360 (throughout the study)
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Day 1- Day 360 (Throughout the study)
62 subjects
FG00560 subjects
FG00659 subjects
FG00755 subjects
FG00881 subjects
12 subjects
FG00513 subjects
FG00612 subjects
FG00718 subjects
FG00819 subjects
5 subjects
FG0042 subjects
FG0053 subjects
FG0065 subjects
FG0077 subjects
FG0082 subjects
Lost to Follow-up
FG0007 subjects
FG0017 subjects
FG0025 subjects
FG0035 subjects
FG0044 subjects
FG0053 subjects
FG0063 subjects
FG0075 subjects
FG0086 subjects
Administrative Reason
FG00011 subjects
FG00114 subjects
FG0029 subjects
FG00312 subjects
FG0046 subjects
FG0057 subjects
FG0064 subjects
FG0076 subjects
FG00810 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Unable to classify
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
BG002
MenACWY (6-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
BG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
BG004
MenACWY (12-15 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
BG005
MenACWY-PnC (12-15 Months Old)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
BG006
MenACWY (16-23 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
BG007
MenACWY+DTaP (16-23 Months Old)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
BG008
MenACWY+PS (3-5 YearsOld)
Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
BG009
Total
Total of all reporting groups
152
BG001153
BG002157
BG003157
BG00474
BG00573
BG00671
BG00773
BG008100
BG0091010
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0003.3± 1.2
BG0013.3± 1.2
BG0028.0± 1.5
BG0038.0± 1.4
BG004NA± NAData are reported in a separate table
BG005NA± NAData are reported in a separate table
BG006NA± NAData are reported in a separate table
BG007NA± NAData are reported in a separate table
BG008NA± NAData are reported in a separate table
BG0095.7± 2.7
Age, Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG000NA± NAData are reported in the previous table
BG001NA± NAData are reported in the previous table
BG002NA± NAData are reported in the previous table
BG003NA± NAData are reported in the previous table
BG00412.2± 0.5
BG00512.2± 0.5
BG00618.2± 1.3
BG00718.2± 1.4
BG00852.6± 11.4
BG00924.7± 17.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00066
BG00179
BG00280
BG00378
BG004NAData are reported in a separate table
BG005NAreported in a separate table
BG006NAreported in a separate table
BG007NAreported in a separate table
BG008NAreported in a separate table
BG009NATotal not calculated because data are not available (NA) in one or more arms.
Male
BG00086
BG00174
BG00277
BG00379
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000NAData are reported in the previous table
BG001NAData are reported in the previous table
BG002NAData are reported in the previous table
BG003NAData are reported in the previous table
BG00430
BG00529
BG00631
BG00736
BG00851
BG009NATotal not calculated because data are not available (NA) in one or more arms.
Male
BG000NAData are reported in the previous table
BG001NAData are reported in the previous table
BG002NAData are reported in the previous table
BG003NAData are reported in the previous table
MenACWY-PS (2-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000284
OG001285
Title
Denominators
Categories
Serogroup A (Day 1), N=280, 281
Title
Measurements
OG0006
OG0011
Serogroup A (Day 29), N=280, 281
Title
Measurements
OG000228
OG001125
Serogroup C (Day 1)
Title
Measurements
OG00080
OG00181
Serogroup C (Day 29)
Title
Measurements
OG000232
OG001181
Serogroup W (Day 1), N=279, 282
Title
Measurements
OG000111
OG001108
Serogroup W (Day 29), N=279, 282
Title
Measurements
OG000263
OG001202
Serogroup Y (Day 1), N=280, 282
Title
Measurements
OG00061
OG00168
Serogroup Y (Day 29), N=280, 282
Title
Measurements
OG000254
OG001167
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
Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A
Vaccine group difference
37
2-Sided
95
29
44
Yes
Non-Inferiority or Equivalence
MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup
OG000
OG001
Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C
Vaccine group difference
19
2-Sided
95
12
26
Yes
Non-Inferiority or Equivalence
MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup
OG000
OG001
Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W
Vaccine group difference
23
2-Sided
95
17
29
Yes
Non-Inferiority or Equivalence
MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup
OG000
OG001
No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y
Vaccine group difference
31
2-Sided
95
25
38
Yes
Non-Inferiority or Equivalence
MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup
OG000
OG001
Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A
MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup
Vaccine group difference
37
2-Sided
95
29
44
No
Superiority or Other
OG000
OG001
Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C
MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup
Vaccine group difference
19
2-Sided
95
12
26
No
Superiority or Other
OG000
OG001
Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W
MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup
Vaccine group difference
23
2-Sided
95
17
29
No
Superiority or Other
OG000
OG001
Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y
MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup
Vaccine group difference
31
2-Sided
95
25
38
No
Superiority or Other
Secondary
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month post vaccination (Day 29)
ID
Title
Description
OG000
MenACWY-CRM (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-PS vaccine
OG002
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM vaccine
OG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000135
OG001138
OG002147
OG003
Title
Denominators
Categories
Serogroup A (Day 1), N=133,138,147,143
Title
Measurements
OG0002(0 to 5)
OG0010(0 to 3)
OG0023(1 to 7)
OG003
Secondary
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
Analysis was done on per protocol population.
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month post vaccination (Day 29)
ID
Title
Description
OG000
MenACWY-CRM (12-23 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (3-5 Years Old)
Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000241
OG00191
Title
Denominators
Categories
Serogroup A (Day 1), N=240,91
Title
Measurements
OG0000(0 to 2)
OG0010(0 to 4)
Serogroup A (Day 29), N=240,91
Title
Measurements
OG000
Secondary
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
Analysis was done on per protocol population.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month post vaccination (Day 29)
ID
Title
Description
OG000
MenACWY-CRM (2-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000281
OG001283
Title
Denominators
Categories
Serogroup A (Day 1), N=280, 281
Title
Measurements
OG0002.06(2.02 to 2.1)
OG0012.02(1.98 to 2.06)
Serogroup A (Day 29), N=280, 281
Title
Measurements
OG000
Secondary
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
Analysis was done on per protocol population.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month post vaccination (Day 29)
ID
Title
Description
OG000
MenACWY-CRM (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the MenACWY-PS vaccine
OG002
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of MenACWY-CRM conjugate vaccine
OG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of MenACWY-PS vaccine
Units
Counts
Participants
OG000135
OG001138
OG002147
OG003
Title
Denominators
Categories
Serogroup A (Day 1), N=133,138,147,143
Title
Measurements
OG0002.04(2 to 2.07)
OG0012(1.97 to 2.03)
OG0022.08(2.01 to 2.15)
Secondary
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
Analysis was done on per protocol population.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month post vaccination (Day 29)
ID
Title
Description
OG000
MenACWY-CRM (12-23 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (3-5 Years Old)
Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.
Units
Counts
Participants
OG000241
OG00191
Title
Denominators
Categories
Serogroup A (Day 1), N=240,91
Title
Measurements
OG0002(2 to 2)
OG0012(2 to 2)
Serogroup A (Day 29), N=240,91
Title
Measurements
OG000
Secondary
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Analysis was done on per protocol population.
Posted
Number
Subjects
12 months post vaccination (Day 360)
ID
Title
Description
OG000
MenACWY-CRM (2-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
OG002
MenACWY-CRM (2-5 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG003
MenACWY-PS (2-5 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
OG004
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG005
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000253
OG001240
OG002119
OG003
Title
Denominators
Categories
Serogroup A (Day 1), N=253,238,119,114,134,124
Title
Measurements
OG0006
OG0011
OG0022
OG003
Secondary
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Analysis was done on per protocol population.
Posted
Geometric Mean
95% Confidence Interval
Titer
12 months post vaccination (Day 360)
ID
Title
Description
OG000
MenACWY-CRM (2-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-10 Years Old)
Subjects received one dose of the licensed MenACWY-PS vaccine
OG002
MenACWY-CRM (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG003
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-PS vaccine
OG004
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
OG005
MenACWY-PS (6-10 Years Old)
Subjects received one dose of the licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000253
OG001240
OG002119
OG003
Title
Denominators
Categories
Serogroup A (Day 1), N=253,238,119,114,134,124
Title
Measurements
OG0002.06(2.02 to 2.11)
OG0012.02(1.97 to 2.07)
OG0022.04(2 to 2.08)
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.
Posted
Number
Subjects
Day 1 to 7 post vaccination
ID
Title
Description
OG000
MenACWY-CRM (2-5 Years Old)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
OG002
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000151
OG001153
OG002157
OG003
Title
Denominators
Categories
Local reactions
Title
Measurements
OG00056
OG00137
OG00270
OG003
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Analysis was done on safety population.
Posted
Number
Subjects
Day 1 to 7 post vaccination
ID
Title
Description
OG000
MenACWY-CRM (12-15 Months)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-CRM + PnC (12-15 Months)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC
OG002
MenACWY-CRM (16-23 Months)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG003
MenACWY-CRM + DTaP (16-23 Months)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP
Units
Counts
Participants
OG00074
OG00171
OG00271
OG003
Title
Denominators
Categories
Local reactions
Title
Measurements
OG00037
OG00129
OG00240
OG003
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Analysis was done on safety population.
Posted
Number
Subjects
Day 1- Day 360 (throughout the study)
ID
Title
Description
OG000
MenACWY-CRM (2-5 Years Old)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
OG002
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
Units
Counts
Participants
OG000151
OG001153
OG002157
OG003157
Title
Denominators
Categories
Any AE
Title
Measurements
OG00056
OG00143
OG00245
OG003
Secondary
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Analysis was done on safety population.
Posted
Number
Subjects
Day 1- Day 360 (Throughout the study)
ID
Title
Description
OG000
MenACWY-CRM (12-15 Months Old)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG001
MenACWY-CRM + PnC (12-15 Months Old)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC
OG002
MenACWY-CRM (16-23 Months)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
OG003
MenACWY-CRM + DTaP (16-23 Months)
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP
Units
Counts
Participants
OG00074
OG00171
OG00271
OG003
Title
Denominators
Categories
Any AE
Title
Measurements
OG00035
OG00133
OG00225
OG003
2
151
82
151
EG001
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
1
153
69
153
EG002
MenACWY (6-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
0
157
81
157
EG003
MenACWY-PS (6-10 Years Old)
Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
0
157
64
157
EG004
MenACWY (12-15 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
2
74
64
74
EG005
MenACWY-PnC (12-15 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
3
71
61
71
EG006
MenACWY (16-23 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
3
71
62
71
EG007
MenACWY+DTaP (16-23 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
2
73
59
73
EG008
MenACWY-PS (3-5 Years Old)
Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
1
100
40
100
EG0000 affected151 at risk
EG0011 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0081 affected100 at risk
DIARRHOEA
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0071 affected73 at risk
EG0080 affected100 at risk
APPENDICITIS
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
APPENDICITIS PERFORATED
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0011 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0081 affected100 at risk
CELLULITIS
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0051 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
EMPYEMA
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
GASTROENTERITIS
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0051 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
LOBAR PNEUMONIA
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
ORAL HERPES
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0041 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
PERITONITIS
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0011 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0081 affected100 at risk
PNEUMONIA
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0051 affected71 at risk
EG0061 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0051 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
FEBRILE CONVULSION
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0061 affected71 at risk
EG0071 affected73 at risk
EG0080 affected100 at risk
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0041 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
BRONCHIAL HYPERREACTIVITY
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0061 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0051 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
SLEEP APNOEA SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0061 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
EG00012 affected151 at risk
EG0016 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG00410 affected74 at risk
EG00512 affected71 at risk
EG00620 affected71 at risk
EG00717 affected73 at risk
EG0084 affected100 at risk
TEETHING
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0047 affected74 at risk
EG0052 affected71 at risk
EG0060 affected71 at risk
EG0073 affected73 at risk
EG0080 affected100 at risk
VOMITING
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG00013 affected151 at risk
EG0016 affected153 at risk
EG0020 affected157 at risk
EG0031 affected157 at risk
EG0041 affected74 at risk
EG0054 affected71 at risk
EG0065 affected71 at risk
EG0076 affected73 at risk
EG0082 affected100 at risk
CHILLS
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG00213 affected157 at risk
EG0035 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
CRYING
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0041 affected74 at risk
EG0053 affected71 at risk
EG0064 affected71 at risk
EG0074 affected73 at risk
EG0080 affected100 at risk
INJECTION SITE ERYTHEMA
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG00023 affected151 at risk
EG00111 affected153 at risk
EG00226 affected157 at risk
EG0039 affected157 at risk
EG00429 affected74 at risk
EG00517 affected71 at risk
EG00630 affected71 at risk
EG00725 affected73 at risk
EG0085 affected100 at risk
INJECTION SITE INDURATION
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG00017 affected151 at risk
EG0015 affected153 at risk
EG00226 affected157 at risk
EG0036 affected157 at risk
EG00416 affected74 at risk
EG00513 affected71 at risk
EG00616 affected71 at risk
EG00710 affected73 at risk
EG0082 affected100 at risk
INJECTION SITE PAIN
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG00043 affected151 at risk
EG00130 affected153 at risk
EG00257 affected157 at risk
EG00343 affected157 at risk
EG00415 affected74 at risk
EG00518 affected71 at risk
EG00619 affected71 at risk
EG00718 affected73 at risk
EG00822 affected100 at risk
MALAISE
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG00212 affected157 at risk
EG0039 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
PYREXIA
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG00012 affected151 at risk
EG00110 affected153 at risk
EG0023 affected157 at risk
EG0034 affected157 at risk
EG0047 affected74 at risk
EG0054 affected71 at risk
EG0064 affected71 at risk
EG0076 affected73 at risk
EG0087 affected100 at risk
CROUP INFECTIOUS
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected151 at risk
EG0011 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0042 affected74 at risk
EG0055 affected71 at risk
EG0061 affected71 at risk
EG0072 affected73 at risk
EG0080 affected100 at risk
OTITIS MEDIA
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0004 affected151 at risk
EG0013 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG0048 affected74 at risk
EG0055 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0082 affected100 at risk
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG00010 affected151 at risk
EG0016 affected153 at risk
EG0024 affected157 at risk
EG0034 affected157 at risk
EG00410 affected74 at risk
EG0056 affected71 at risk
EG0060 affected71 at risk
EG0075 affected73 at risk
EG0082 affected100 at risk
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected151 at risk
EG0010 affected153 at risk
EG00212 affected157 at risk
EG0034 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0080 affected100 at risk
HEADACHE
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0007 affected151 at risk
EG0013 affected153 at risk
EG00229 affected157 at risk
EG00318 affected157 at risk
EG0040 affected74 at risk
EG0050 affected71 at risk
EG0060 affected71 at risk
EG0070 affected73 at risk
EG0083 affected100 at risk
SOMNOLENCE
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG00025 affected151 at risk
EG00124 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG00422 affected74 at risk
EG00532 affected71 at risk
EG00621 affected71 at risk
EG00725 affected73 at risk
EG00813 affected100 at risk
EATING DISORDER
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG00018 affected151 at risk
EG00116 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG00411 affected74 at risk
EG00520 affected71 at risk
EG00613 affected71 at risk
EG00718 affected73 at risk
EG0089 affected100 at risk
IRRITABILITY
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG00029 affected151 at risk
EG00126 affected153 at risk
EG0020 affected157 at risk
EG0030 affected157 at risk
EG00436 affected74 at risk
EG00540 affected71 at risk
EG00633 affected71 at risk
EG00732 affected73 at risk
EG00814 affected100 at risk
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected151 at risk
EG0012 affected153 at risk
EG0021 affected157 at risk
EG0031 affected157 at risk
EG0042 affected74 at risk
EG0054 affected71 at risk
EG0061 affected71 at risk
EG0071 affected73 at risk
EG0081 affected100 at risk
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
NA
reported in a separate table
BG005NAreported in a separate table
BG006NAreported in a separate table
BG007NAreported in a separate table
BG008NAreported in a separate table
BG009NATotal not calculated because data are not available (NA) in one or more arms.
BG00444
BG00544
BG00640
BG00737
BG00849
BG009NATotal not calculated because data are not available (NA) in one or more arms.
145
1
(0.018 to 4)
Serogroup A (Day 29), N=133,138,147,143
Title
Measurements
OG00080(72 to 86)
OG00143(34 to 51)
OG00283(76 to 89)
OG00346(38 to 55)
Serogroup C (Day 1), N=135,138,146,145
Title
Measurements
OG00023(16 to 31)
OG00111(6 to 17)
OG00234(26 to 42)
OG00346(37 to 54)
Serogroup C (Day 29), N=135,138,146,145
Title
Measurements
OG00076(68 to 83)
OG00145(36 to 54)
OG00288(82 to 93)
OG00382(75 to 88)
Serogroup W (Day 1), N=135,138,144,144
Title
Measurements
OG00032(24 to 40)
OG00122(16 to 30)
OG00247(39 to 56)
OG00353(45 to 62)
Serogroup W (Day 29), N=135,138,144,144
Title
Measurements
OG00090(84 to 95)
OG00155(46 to 64)
OG00298(94 to 100)
OG00388(81 to 92)
Serogroup Y (Day 1), N=134,138,146,144
Title
Measurements
OG00018(12 to 25)
OG00113(8 to 20)
OG00225(19 to 33)
OG00335(27 to 43)
Serogroup Y (Day 29), N=134,138,146,144
Title
Measurements
OG00087(80 to 92)
OG00149(40 to 57)
OG00295(89 to 98)
OG00369(61 to 77)
81
(76 to 86)
OG00151(40 to 61)
Serogroup C (Day 1), N=241,91
Title
Measurements
OG0003(1 to 6)
OG00112(6 to 21)
Serogroup C (Day 29), N=241,91
Title
Measurements
OG00090(86 to 94)
OG00142(32 to 53)
Serogroup W (Day 1), N=240,91
Title
Measurements
OG0003(1 to 6)
OG00124(16 to 34)
Serogroup W (Day 29), N=240,91
Title
Measurements
OG00086(81 to 90)
OG00163(52 to 73)
Serogroup Y (Day 1), N=238,91
Title
Measurements
OG0002(1 to 5)
OG00115(9 to 24)
Serogroup Y (Day 29), N=238,91
Title
Measurements
OG00064(58 to 70)
OG00151(40 to 61)
36
(30 to 44)
OG0016.31(5.21 to 7.64)
Serogroup C (Day 1)
Title
Measurements
OG0003.07(2.77 to 3.4)
OG0013.33(3.01 to 3.68)
Serogroup C (Day 29)
Title
Measurements
OG00026(21 to 34)
OG00115(12 to 20)
Serogroup W (Day 1), N=279, 282
Title
Measurements
OG0005.74(4.86 to 6.78)
OG0015.63(4.77 to 6.65)
Serogroup W (Day 29), N=279, 282
Title
Measurements
OG00060(50 to 71)
OG00114(12 to 17)
Serogroup Y (Day 1), N=280, 282
Title
Measurements
OG0003.32(2.95 to 3.73)
OG0013.34(2.97 to 3.76)
Serogroup Y (Day 29), N=280, 282
Title
Measurements
OG00054(44 to 66)
OG00111(9.29 to 14)
145
OG003
2.03
(1.96 to 2.11)
Serogroup A (Day 29), N=133,138,147,143
Title
Measurements
OG00028(22 to 37)
OG0015.8(4.49 to 7.5)
OG00245(34 to 60)
OG0036.84(5.17 to 9.06)
Serogroup C (Day 1), N=135,138,146,145
Title
Measurements
OG0002.81(2.52 to 3.13)
OG0012.38(2.14 to 2.65)
OG0023.33(2.84 to 3.9)
OG0034.58(3.91 to 5.38)
Serogroup C (Day 29), N=135,138,146,145
Title
Measurements
OG00014(11 to 19)
OG0016.93(5.22 to 9.18)
OG00247(34 to 67)
OG00333(23 to 47)
Serogroup W (Day 1), N=135,138,144,144
Title
Measurements
OG0004.68(3.78 to 5.8)
OG0013.64(2.95 to 4.5)
OG0026.94(5.45 to 8.84)
OG0038.55(6.71 to 11)
Serogroup W (Day 29), N=135,138,144,144
Title
Measurements
OG00043(34 to 56)
OG0017.84(6.12 to 10)
OG00280(65 to 99)
OG00324(20 to 30)
Serogroup Y (Day 1), N=134,138,146,144
Title
Measurements
OG0003(2.61 to 3.44)
OG0012.57(2.24 to 2.95)
OG0023.65(3.03 to 4.38)
OG0034.3(3.58 to 5.18)
Serogroup Y (Day 29), N=134,138,146,144
Title
Measurements
OG00042(31 to 56)
OG0017.17(5.37 to 9.58)
OG00268(51 to 90)
OG00318(13 to 24)
18
(15 to 21)
OG0017.18(5.34 to 9.64)
Serogroup C (Day 1), N=241,91
Title
Measurements
OG0002.13(2.02 to 2.25)
OG0012.44(2.23 to 2.68)
Serogroup C (Day 29), N=241,91
Title
Measurements
OG00022(18 to 26)
OG0017.09(5.29 to 9.5)
Serogroup W (Day 1), N=240,91
Title
Measurements
OG0002.13(1.94 to 2.33)
OG0013.91(3.36 to 4.55)
Serogroup W (Day 29), N=240,91
Title
Measurements
OG00018(15 to 21)
OG0019.52(7.21 to 13)
Serogroup Y (Day 1), N=238,91
Title
Measurements
OG0002.11(1.97 to 2.25)
OG0012.69(2.42 to 3)
Serogroup Y (Day 29), N=238,91
Title
Measurements
OG00011(8.91 to 14)
OG0018.48(6.01 to 12)
114
OG004134
OG005126
0
OG0044
OG0051
Serogroup A (Day 360), N=253,238,119,114,134,124
Title
Measurements
OG00071
OG00144
OG00227
OG00315
OG00444
OG00529
Serogroup C (Day 1), N=252,240,119,114,133,126
Title
Measurements
OG00070
OG00172
OG00226
OG00312
OG00444
OG00560
Serogroup C (Day 360), N=252,240,119,114,133,126
Title
Measurements
OG000172
OG001126
OG00277
OG00341
OG00495
OG00585
Serogroup W (Day 1), N=249,237,119,113,130,124
Title
Measurements
OG00096
OG00185
OG00235
OG00321
OG00461
OG00564
Serogroup W (Day 360), N=249,237,119,113,130,124
Title
Measurements
OG000234
OG001119
OG002108
OG00341
OG004126
OG00578
Serogroup Y (Day 1), N=250,239,118,113,132,126
Title
Measurements
OG00053
OG00159
OG00222
OG00314
OG00431
OG00545
Serogroup Y (Day 360), N=250,239,118,113,132,126
Title
Measurements
OG000215
OG00190
OG002101
OG00326
OG004114
OG00564
114
OG004134
OG005126
OG003
2
(1.96 to 2.04)
OG0042.09(2 to 2.17)
OG0052.04(1.95 to 2.12)
Serogroup A (Day 360), N=253,238,119114,134,124
Title
Measurements
OG0003.88(3.39 to 4.44)
OG0013(2.61 to 3.44)
OG0023.15(2.73 to 3.64)
OG0032.49(2.15 to 2.89)
OG0044.66(3.75 to 5.8)
OG0053.55(2.83 to 4.45)
Serogroup C (Day 1), N=252,240,119,114,133,126
Title
Measurements
OG0003.04(2.73 to 3.39)
OG0013.43(3.07 to 3.84)
OG0022.77(2.47 to 3.12)
OG0032.38(2.11 to 2.69)
OG0043.3(2.79 to 3.9)
OG0054.77(4.01 to 5.67)
Serogroup C (Day 360), N=252,240,119,114,133,126
Title
Measurements
OG00011(8.64 to 13)
OG0019.02(7.23 to 11)
OG0027.53(5.93 to 9.55)
OG0034.71(3.69 to 6.01)
OG00415(11 to 21)
OG00516(12 to 23)
Serogroup W (Day 1), N=249,237,119,113,130,124
Title
Measurements
OG0005.5(4.62 to 6.55)
OG0015.38(4.5 to 6.44)
OG0024.4(3.52 to 5.51)
OG0033.43(2.73 to 4.32)
OG0046.75(5.23 to 8.7)
OG0058.1(6.25 to 11)
Serogroup W (Day 360), N=249,237,119,113,130,124
Title
Measurements
OG00042(35 to 50)
OG0017.57(6.33 to 9.07)
OG00236(28 to 46)
OG0034.95(3.83 to 6.4)
OG00449(38 to 62)
OG00511(8.75 to 14)
Serogroup Y (Day 1), N=250,239,118,113,132,126
Title
Measurements
OG0003.29(2.9 to 3.73)
OG0013.4(2.99 to 3.87)
OG0023.04(2.62 to 3.53)
OG0032.56(2.2 to 2.98)
OG0043.53(2.91 to 4.27)
OG0054.39(3.61 to 5.35)
Serogroup Y (Day 360), N=250,239,118,113,132,126
Title
Measurements
OG00027(22 to 33)
OG0015.29(4.34 to 6.45)
OG00224(19 to 31)
OG0033.42(2.65 to 4.43)
OG00430(23 to 40)
OG0057.82(5.86 to 10)
157
50
Injection site pain
Title
Measurements
OG00043
OG00130
OG00257
OG00343
Injection site erythema
Title
Measurements
OG00023
OG00111
OG00226
OG0039
Injection site induration
Title
Measurements
OG00017
OG0015
OG00226
OG0036
Systemic reactions
Title
Measurements
OG00055
OG00145
OG00239
OG00328
Change in eating habits, N=145,150
Title
Measurements
OG00018
OG00116
OG002NA
OG003NA
Sleepiness
Title
Measurements
OG00025
OG00124
OG002NA
OG003NA
Irritability
Title
Measurements
OG00029
OG00126
OG002NA
OG003NA
Vomiting
Title
Measurements
OG00012
OG0016
OG002NA
OG003NA
Diarrhea
Title
Measurements
OG00011
OG0016
OG002NA
OG003NA
Chills, N=156, 157
Title
Measurements
OG000NA
OG001NA
OG00213
OG0035
Nausea, N=156, 157
Title
Measurements
OG000NA
OG001NA
OG0026
OG0036
Malaise, N=156, 157
Title
Measurements
OG000NA
OG001NA
OG00212
OG0039
Myalgia, N=156, 157
Title
Measurements
OG000NA
OG001NA
OG00212
OG0034
Arthralgia, N=151,153,156,157
Title
Measurements
OG0003
OG0017
OG0025
OG0033
Headache, N=151,153,156,157
Title
Measurements
OG0006
OG0013
OG00229
OG00317
Other
Title
Measurements
OG00040
OG00131
OG00237
OG00323
Stayed at home due to reactions, N=146,151,154,156