Evaluation of Meningococcal ACWY Immune Response in Child... | NCT00601731 | Trialant
NCT00601731
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Oct 24, 2014Estimated
Enrollment
382Actual
Phase
Phase 2
Conditions
Meningococcal Disease
Interventions
MenACWY-CRM197
Blood test
Countries
Canada
United Kingdom
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
NCT00601731
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V59P5E1
Secondary IDs
ID
Type
Description
Link
2007-004978-16
Brief Title
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Official Title
A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 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
Feb 2008
Primary Completion Date
Jul 2010Actual
Completion Date
Sep 2010Actual
First Submitted Date
Jan 15, 2008
First Submission Date that Met QC Criteria
Jan 25, 2008
First Posted Date
Jan 28, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 28, 2011
Results First Submitted that Met QC Criteria
Sep 17, 2012
Results First Posted Date
Sep 19, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 20, 2011
Certification/Extension First Submitted that Passed QC Review
Jul 20, 2011
Certification/Extension First Posted Date
Jul 25, 2011Estimated
Last Update Submitted Date
Oct 14, 2014
Last Update Posted Date
Oct 24, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Name
Class
Novartis
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Disease
Keywords
Prevention of Meningococcal disease
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
382Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adjuvanted MenACWY vaccine group
Experimental
Blood test
Biological: MenACWY-CRM197
Non-adjuvanted MenACWY vaccine group
Active Comparator
Blood test
Biological: Blood test
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MenACWY-CRM197
Biological
Blood test, 40-months and 60-months children
Adjuvanted MenACWY vaccine group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects With hSBA ≥1:8
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
At 40 and 60 months of age
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects With hSBA ≥1:4
Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
At 40 and 60 months of age
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
Control subjects: healthy 60 months old who had received a complete MenC immunization course
Exclusion Criteria:
Subjects with any serious, acute or chronic progressive disease
Khatami A, Snape MD, Davis E, Layton H, John T, Yu LM, Dull PM, Gill CJ, Odrjlin T, Dobson S, Halperin SA, Langley JM, McNeil SA, Pollard AJ. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012 Apr 16;30(18):2831-8. doi: 10.1016/j.vaccine.2012.02.046. Epub 2012 Mar 3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Participants were enrolled at 3 sites (1 site in the UK and 2 sites in Canada).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
UK Site
UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
FG001
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
FG002
Canada Sites
Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
FG003
Canada Control
Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000143 subjects
FG00143 subjects
FG002166 subjects
FG00330 subjects
COMPLETED
FG000120 subjects
FG00143 subjects
FG002151 subjects
FG00329 subjects
NOT COMPLETED
FG00023 subjects
FG0010 subjects
FG00215 subjects
FG0031 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
UK2,3,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
BG001
UK2,4,12+
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, Customized
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
Percentage of Subjects With hSBA ≥1:8
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.
Posted
Number
95% Confidence Interval
Percentages of subjects
At 40 and 60 months of age
ID
Title
Description
OG000
UK2,3,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
Adverse Events Module
Frequency Threshold
5
Time Frame
Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).
Description
The analyses for serious adverse events (SAEs) and adverse events (AEs) were done on the safety population (i.e., all subjects enrolled who received study vaccination and provided post-baseline safety data).
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
UK2,3,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lower respiratory tract infection
Infections and infestations
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Otitis media
Infections and infestations
Non-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
MeSH Terms
ID
Term
D008589
Meningococcal Infections
Ancestor Terms
ID
Term
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D006403
Hematologic Tests
Ancestor Terms
ID
Term
D019411
Clinical Laboratory Techniques
D019937
Diagnostic Techniques and Procedures
D003933
Diagnosis
D008919
Investigative Techniques
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Blood test
Biological
Blood test, 40-months and 60-months children
Non-adjuvanted MenACWY vaccine group
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.
At 40 and 60 months of age
Vancouver
Canada
Oxford Vaccine Group
Oxford
OX3 7LJ
United Kingdom
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
BG002
UK2,4C/12+
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
BG003
UK2,4,12-
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
BG004
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
BG005
Ca2,4,6+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
BG006
Ca2,4,6+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
BG007
Ca2,4,12+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
BG008
Ca2,4+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
BG009
Ca2,4,12-
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
BG010
Ca2,4-/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
BG011
Ca Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
BG012
Total
Total of all reporting groups
40
BG00144
BG00222
BG00337
BG00443
BG00531
BG00626
BG00727
BG00828
BG00927
BG01027
BG01130
BG012382
Standard Deviation
months
Title
Denominators
Categories
40 months (N=36,37,19,34,0,28,23,27,28,25,26,0)
Title
Measurements
BG00042.4± 0.7
BG00142.6± 0.6
BG00242.6± 0.5
BG00340.6± 0.8
BG004NA± NAZero participants were in this subgroup.
BG00542± 1
BG00641.8± 1.2
BG00742± 0.9
BG00841.6± 1
BG00940.7± 1
BG01041.0± 1.1
BG011NA± NAZero participants were in this subgroup.
BG01234.78± 0.31
60 months (N=4,7,3,3,43,3,3,0,0,2,1,30)
Title
Measurements
BG00061.3± 1.0
BG00161.3± 0.5
BG00261.0± 1.0
BG003
Sex/Gender, Customized
Number
Number of subjects
Title
Denominators
Categories
Female 40 months
Title
Measurements
BG00014
BG00119
BG00214
BG00319
BG004NAZero participants were in this subgroup.
BG00519
BG0069
BG00715
BG00810
BG00912
BG01014
BG011NAZero participants were in this subgroup.
BG012145
Male 40 months
Title
Measurements
BG00022
BG00118
BG0025
BG003
Female 60 months
Title
Measurements
BG0001
BG0014
BG0021
BG003
Male 60 months
Title
Measurements
BG0003
BG0013
BG0022
BG003
OG001
UK2,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG002
UK2,4C/12+
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG003
UK2,4,12-
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
OG004
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
OG005
Ca2,4,6+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
OG006
Ca2,4,6+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
OG007
Ca2,4,12+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG008
Ca2,4+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
OG009
Ca2,4,12-
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
OG010
Ca2,4-/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
OG011
Ca Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
Units
Counts
Participants
OG00033
OG00137
OG00218
OG00334
OG00442
OG00528
OG00625
OG00727
OG00828
OG00925
OG01024
OG01130
Title
Denominators
Categories
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
Title
Measurements
OG00027(13 to 46)
OG0018(2 to 22)
OG00229(10 to 56)
OG0033(0.074 to 15)
OG004NA(NA to NA)zero participants analyzed
OG0050(0 to 12)
OG0064(0 to 22)
OG0077(1 to 24)
OG0080(0 to 12)
OG0098(1 to 26)
OG0100(0 to 14)
OG011NA(NA to NA)zero participants analyzed
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30
Title
Measurements
OG0009(2 to 24)
OG00111(3 to 27)
OG00211(1 to 35)
OG003
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0
Title
Measurements
OG00041(24 to 59)
OG00147(30 to 65)
OG00271(44 to 90)
OG003
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30
Title
Measurements
OG00034(19 to 53)
OG00132(17 to 51)
OG00259(33 to 82)
OG003
MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
Title
Measurements
OG00073(54 to 87)
OG00169(52 to 84)
OG00271(44 to 90)
OG003
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29
Title
Measurements
OG00069(50 to 84)
OG00185(69 to 95)
OG00278(52 to 94)
OG003
MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0
Title
Measurements
OG00076(58 to 89)
OG00161(43 to 77)
OG00276(50 to 93)
OG003
MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30
Title
Measurements
OG00061(42 to 77)
OG00171(53 to 85)
OG00271(44 to 90)
OG003
Secondary
Percentage of Subjects With hSBA ≥1:4
Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
The analysis was done on MITT population
Posted
Number
95% Confidence Interval
Percentages of subjects
At 40 and 60 months of age
ID
Title
Description
OG000
UK2,3,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG001
UK2,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG002
UK2,4C/12+
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG003
UK2,4,12-
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
OG004
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
OG005
Ca2,4,6+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
OG006
Ca2,4,6+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
OG007
Ca2,4,12+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG008
Ca2,4+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
OG009
Ca2,4,12-
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
OG010
Ca2,4-/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
OG011
Ca Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
Units
Counts
Participants
OG00033
OG00137
OG00218
OG003
Title
Denominators
Categories
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
Title
Measurements
OG00030(16 to 49)
OG0018(2 to 22)
OG00229(10 to 56)
Secondary
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.
The analysis was done on MITT population
Posted
Geometric Mean
95% Confidence Interval
Titers
At 40 and 60 months of age
ID
Title
Description
OG000
UK2,3,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG001
UK2,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG002
UK2,4C/12+
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG003
UK2,4,12-
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
OG004
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
OG005
Ca2,4,6+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
OG006
Ca2,4,6+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
OG007
Ca2,4,12+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
OG008
Ca2,4+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
OG009
Ca2,4,12-
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
OG010
Ca2,4-/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
OG011
Ca Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
Units
Counts
Participants
OG00033
OG00137
OG00218
OG003
Title
Denominators
Categories
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0
Title
Measurements
OG0003.75(2.76 to 5.11)
OG0012.58(1.93 to 3.45)
OG0024.33(2.82 to 6.66)
1
33
5
33
EG001
UK2,4,12+
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1
33
3
33
EG002
UK2,4C/12+
UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
0
16
3
16
EG003
UK2,4,12-
UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
3
29
2
29
EG004
UK Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
0
26
0
26
EG005
Ca2,4,6+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
1
28
1
28
EG006
Ca2,4,6+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
0
25
1
25
EG007
Ca2,4,12+
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
0
24
3
24
EG008
Ca2,4+/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
0
26
1
26
EG009
Ca2,4,12-
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
0
22
2
22
EG010
Ca2,4-/12PS
Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1
25
1
25
EG011
Ca Control
Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.