A Study to Evaluate Safety and Immune Response of Novarti... | NCT00474526 | Trialant
NCT00474526
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Mar 24, 2014Estimated
Enrollment
4,545Actual
Phase
Phase 3
Conditions
Meningitis, Meningococcal
Interventions
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
DTaP
Countries
United States
Argentina
Colombia
Protocol Section
Identification Module
NCT ID
NCT00474526
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V59P14
Secondary IDs
Not provided
Brief Title
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Official Title
A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Feb 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
Mar 2007
Primary Completion Date
Sep 2008Actual
Completion Date
Nov 2009Actual
First Submitted Date
May 16, 2007
First Submission Date that Met QC Criteria
May 16, 2007
First Posted Date
May 17, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 27, 2013
Results First Submitted that Met QC Criteria
Feb 24, 2014
Results First Posted Date
Mar 24, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 16, 2010
Certification/Extension First Submitted that Passed QC Review
Apr 16, 2010
Certification/Extension First Posted Date
Apr 20, 2010Estimated
Last Update Submitted Date
Feb 24, 2014
Last Update Posted Date
Mar 24, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Detailed Description
Not provided
Conditions Module
Conditions
Meningitis, Meningococcal
Keywords
Meningococcal
meningitis
vaccine
infants
Meningococcal meningitis
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
4,545Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
US1A (MenACWY-CRM + Infant Vaccines)
Experimental
Received vaccines:
MenACWY: 2, 4, 6, and 12 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
13 months of age (one month post-toddler vaccination)
Geometric Mean hSBA Titers - US Subjects
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
13 months of age (one month post-toddler vaccination)
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
7 days after vaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.
Exclusion Criteria:
Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease
Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012 Jan;31(1):64-71. doi: 10.1097/INF.0b013e31823dce5c.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Experimental
Received vaccines:
MenACWY: 2, 4, 6, and 12 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
ProQuadâ„¢ (Measles, Mumps, Rubella and Varicella vaccine)
DTaP
Biological
LA3A (MenACWY-CRM + Infant Vaccines)
LA3B (MenACWY-CRM + Infant Vaccines)
LA4 (Infant Vaccines Only)
Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
7 days post vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
7 days post vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
7 days post-vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
7 days post-vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
7 days post-vaccination
Geometric Mean hSBA Titers Post-infant Series - US Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.
7 months of age (one month post-infant series)
Geometric Mean hSBA Titers Post-infant Series - LA Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.
7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
7 months of age (one month post-infant series)
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
7 months of age (one month post-infant series)
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
7 months of age (one month post-infant series)
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
7 months of age (one month post-infant series)
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
7 months of age (one month post-infant series)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
12 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
12 Months of Age (one month pre-toddler vaccination)
Persistence Antibodies Geometric Mean Titers - US Subject
Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
12 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
12 or 16 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
12 or 16 Months of Age (one month pre-toddler vaccination)
Persistence Antibodies Geometric Mean Titers - LA Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
12 or 16 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.
13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.
13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.
13 months of age (one month post-toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.
13 or 17 Months of Age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
13 or 17 Months of Age (one month post-toddler vaccination)
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.
13 or 17 Months of Age (one month post-toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
13 or 17 Months of Age (one month post-toddler vaccination)
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
13 months of age (one month post-toddler vaccination)
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
13 months of age (one month post-toddler vaccination)
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
13 months of age (one month post-toddler vaccination)
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F
13 months of age (one month post-toddler vaccination)
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
17 months of age (one month post-toddler vaccination)
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
17 months of age (one month post-toddler vaccination)
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Birmingham
Alabama
03523
United States
Growing Up Pediatrics
Birmingham
Alabama
35242
United States
Premier Health Research Center, LLC
Downey
California
90241
United States
Kaiser Permanente Oakland
Oakland
California
94611
United States
Kaiser Permanente Med Group - Vaccine Study Ctr
Oakland
California
94612
United States
Center for Clinical Trials, LLC
Paramount
California
90723
United States
Kaiser Permanente Pleasanton
Pleasanton
California
94588
United States
Kaiser Permanente Richmond
Richmond
California
94801
United States
Kaiser Permanente San Francisco
San Francisco
California
94115
United States
Kaiser Permanente Santa Clara
Santa Clara
California
95051
United States
UCLA Center for Vaccine Research
Torrence
California
90502
United States
The Children's Hospital
Aurora
Colorado
80045
United States
Longmont Medical Research Network
Longmont
Colorado
80501
United States
Children's Memorial Hospital
Chicago
Illinois
60614-3394
United States
Kentucky Pediatric/Adult Research Inc.
Bardstown
Kentucky
40004
United States
Annapolis Pediatrics
Annapolis
Maryland
21401
United States
Center for Vaccine Development
Baltimore
Maryland
21201
United States
The Pediatric Center
Frederick
Maryland
21702
United States
Boston University Medical Center
Boston
Massachusetts
02118
United States
Pediatric Associates of Fall River
Fall River
Massachusetts
02724
United States
Creighton University
Omaha
Nebraska
68131
United States
Children's Physicians Dundee
Omaha
Nebraska
68132
United States
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Montefiore Medical Center
The Bronx
New York
10461
United States
Akron Children's Hospital
Akron
Ohio
44308
United States
Louis P. Brine, Jr., MD, Beeghley Medical Park
Boardman
Ohio
44512
United States
Senders Pediatric Research at Dr. Senders and Associates
Cleveland
Ohio
44118
United States
Carnegie Pediatrics
Carnegie
Pennsylvania
15106
United States
Children's Health Care - West
Erie
Pennsylvania
16505
United States
UPMC/Community Medicine, Inc.
Greenville
Pennsylvania
16125
United States
Family Healthcare Partners
Grove City
Pennsylvania
16127
United States
Pennridge Pediatric Associates
Harleyville
Pennsylvania
19438
United States
Pediatric Associates of Latrobe
Latrobe
Pennsylvania
15650
United States
Pediatric Medical Associates
Norristown
Pennsylvania
19401
United States
Squirrel Hill Office
Pittsburgh
Pennsylvania
15217
United States
Pediatric Alliance, Greentree Division
Pittsburgh
Pennsylvania
15220
United States
South Hills Pediatrics
Pittsburgh
Pennsylvania
15227
United States
Pediatric Alliance, Southwestern
Pittsburgh
Pennsylvania
15236
United States
Primary Physicians Research, Inc
Pittsburgh
Pennsylvania
15241
United States
Pediatrics Medical Associates
Rydal
Pennsylvania
19046
United States
Pennridge Pediatric Associates
Sellersville
Pennsylvania
18960
United States
Laurel Pediatrics
Uniontown
Pennsylvania
15401
United States
CCP - Pittsburgh Pediatrics
Wexford
Pennsylvania
15090
United States
Goodlettsville Pediatrics
Madison
Tennessee
37115-2154
United States
Research Across America
Dallas
Texas
75234
United States
Mercury Pharma Services
Houston
Texas
77024
United States
Scott and White Hospital
Temple
Texas
76508
United States
Wee Care Pediatrics
Layton
Utah
84041
United States
Utah Valley Pediatrics - Timpanogos
Orem
Utah
84057
United States
Foothill Family Clinic
Salt Lake City
Utah
84121
United States
Copperview Medical Center
South Jordan
Utah
84095
United States
Monroe Medical Foundation
Monroe
Wisconsin
53566
United States
CEDEPAP Rio IV
Alvear 1439 PB Dpto, Rio IV, Cordoba
Córdoba Province
Argentina
Hospitales Materno Neonatal,
Castro Barros 650 - Barrio San Martin, Cordoba
Córdoba Province
Argentina
CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
Córdoba
Córdoba Province
X5000BJH
Argentina
Hospital Regional Luis Pasteur,
Mendoza N°2152, Villa Maria, Cordoba,
Córdoba Province
Argentina
Buenos Aires, Argentina
Buenos Aires
C1406DGI
Argentina
Centro Estudios Infect
Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,
Argentina
Siloe
Calle 1 #50-51
Cali
405
Colombia
Comfenalco
Calle 6#5-42
Cali
405
Colombia
Hospital C H Trujillo
Calle 72U 28 F-00
Cali
405
Colombia
Corporation Cientifica
Ped Calle 5B5 No.37 Bis-28
Cali
405
Colombia
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
FG002
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
FG003
US3 (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
FG004
US4A (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
FG005
US4B (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
FG006
US4C (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
FG007
LA1A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
FG008
LA1B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
FG009
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
FG010
LA3A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
FG011
LA3B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
FG012
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
FG013
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
FG014
LA6A (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
FG015
LA6B (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
FG016
LA6C (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
FG000154 subjects
FG001166 subjects
FG002159 subjects
FG003680 subjects
FG00476 subjects
FG00570 subjects
FG006203 subjects
FG007151 subjects
FG008150 subjects
FG009148 subjects
FG010151 subjects
FG011150 subjects
FG012150 subjects
FG0131426 subjects
FG014358 subjects
FG015170 subjects
FG016183 subjects
COMPLETED
FG000121 subjects
FG001120 subjects
FG002110 subjects
FG003561 subjects
FG0048 subjects
FG00554 subjects
FG006178 subjects
FG007145 subjects
FG008144 subjects
FG009121 subjects
FG010141 subjects
FG011139 subjects
FG012135 subjects
FG0131270 subjects
FG014281 subjects
FG015152 subjects
FG016174 subjects
NOT COMPLETED
FG00033 subjects
FG00146 subjects
FG00249 subjects
FG003119 subjects
FG00468 subjects
FG00516 subjects
FG00625 subjects
FG0076 subjects
FG0086 subjects
FG00927 subjects
FG01010 subjects
FG01111 subjects
FG01215 subjects
FG013156 subjects
FG01477 subjects
FG01518 subjects
FG0169 subjects
Type
Comment
Reasons
ADMINISTRATIVE REASON
FG00011 subjects
FG0019 subjects
FG0029 subjects
FG00320 subjects
FG0049 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0101 subjects
FG0111 subjects
FG0121 subjects
FG0131 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
Adverse Event
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
INAPPROPRIATE ENROLLMENT
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0008 subjects
FG0016 subjects
FG00213 subjects
FG00329 subjects
FG004
Protocol Violation
FG0002 subjects
FG0016 subjects
FG0024 subjects
FG00312 subjects
FG004
UNABLE TO CLASSIFY
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0009 subjects
FG00124 subjects
FG00221 subjects
FG00352 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
BG001
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
BG002
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
BG003
US3 (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
BG004
US4A (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
BG005
US4B (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
BG006
US4C (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
BG007
LA1A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
BG008
LA1B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
BG009
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
BG010
LA3A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
BG011
LA3B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
BG012
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
BG013
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
BG014
LA6A (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
BG015
LA6B (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
BG016
LA6C (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
BG017
TOTAL
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000154
BG001166
BG002159
BG003680
BG00476
BG00570
BG006203
BG007151
BG008150
BG009148
BG010151
BG011150
BG012150
BG0131426
BG014358
BG015170
BG016183
BG0174545
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG00066.1± 7.2
BG00165.8± 6.6
BG00265.7± 6.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00068
BG00172
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 Subjects With hSBA Titer >=1:8 - US Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
The analysis was done on per protocol population
Per protocol was defined as subjects who:
received all the relevant doses of vaccine correctly
provided evaluable serum samples at the relevant time points
had no major protocol deviation as defined prior to database lock
Posted
Number
95% Confidence Interval
Percentages of subjects
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Units
Counts
Participants
OG00086
OG00174
Title
Denominators
Categories
A (84, 74)
Title
Measurements
OG00094(87 to 98)
OG00172(60 to 81)
C (86, 73)
Title
Measurements
OG000
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed.
Posted
Number
Subjects
7 days after vaccination
ID
Title
Description
OG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG001
US1B (MenACWY-CRM + Infant Vaccines )
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age.
Posted
Number
Subjects
7 days after vaccination
ID
Title
Description
OG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG001
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
OG002
US1 (MenACWY-CRM + Infant Vaccines)
Primary
Geometric Mean hSBA Titers - US Subjects
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines )
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.
Posted
Number
Subjects
7 days after vaccination
ID
Title
Description
OG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG001
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
OG002
US1 (MenACWY-CRM + Infant Vaccines)
Secondary
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.
Posted
Number
Subjects
7 days after vaccination
ID
Title
Description
OG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG001
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
OG002
US1A + US3 (MenACWY-CRM + Infant Vaccines)
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.
Posted
Number
Subjects
7 days post vaccination
ID
Title
Description
OG000
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
OG001
US1A + US3 (MenACWY-CRM + Infant Vaccines)
Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG002
US2 + US4A (Infant Vaccines Only)
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis.
Posted
Number
Subjects
7 days post vaccination
ID
Title
Description
OG000
US2 + US4A (Infant Vaccines Only)
Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG001
US4B (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
OG002
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.
Posted
Number
Subjects
7 days post-vaccination
ID
Title
Description
OG000
US1 + US3 (Men ACWY-CRM + Infant Vaccines)
Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled.
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
OG001
US2 + US4 (Infant Vaccines Only)
Groups Infant Vaccines only (US2+US4) pooled
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:
either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C).
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis.
Posted
Number
Subjects
7 days post-vaccination
ID
Title
Description
OG000
US1+US3 (Men ACWY-CRM + Infant Vaccines)
Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
OG001
US2+US4 (Infant Vaccines Only)
Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
Secondary
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis.
Posted
Number
Subjects
7 days post-vaccination
ID
Title
Description
OG000
US1+US3 (Men ACWY-CRM + Infant Vaccines)
Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
OG001
US2+US4 (Infant Vaccines Only)
Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
Secondary
Geometric Mean hSBA Titers Post-infant Series - US Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
7 months of age (one month post-infant series)
ID
Title
Description
OG000
US1 (MenACWY-CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B.
OG001
US2 (Infant Vaccines Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Units
Counts
Participants
Secondary
Geometric Mean hSBA Titers Post-infant Series - LA Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.
Per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titer
7 months of age (one month post-infant series)
ID
Title
Description
OG000
LA1 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA3 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
Units
Counts
Participants
Secondary
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
Per Protocol Population
Posted
Number
95% Confidence Interval
Percentages of subjects
7 months of age (one month post-infant series)
ID
Title
Description
OG000
US1 (MenACWY-CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG001
US2 (Infant Vaccines Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Units
Counts
Secondary
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
Per Protocol Population
Posted
Number
95% Confidence Interval
Percentages of subjects
7 months of age (one month post-infant series)
ID
Title
Description
OG000
US1 (MenACWY-CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG001
US2 (Infant Vaccines Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Units
Counts
Secondary
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
Per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
7 months of age (one month post-infant series)
ID
Title
Description
OG000
LA1 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA3 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
Units
Counts
Participants
Secondary
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
Per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
7 months of age (one month post-infant series)
ID
Title
Description
OG000
LA1 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA3 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
Units
Counts
Participants
Secondary
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Per Protocol
Posted
Geometric Mean
95% Confidence Interval
Titers
7 months of age (one month post-infant series)
ID
Title
Description
OG000
US1 (Men ACWY-CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG001
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
Units
Counts
Participants
Secondary
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Per Protocol
Posted
Number
95% Confidence Interval
Percentages of subjects
7 months of age (one month post-infant series)
ID
Title
Description
OG000
US1 (Men ACWY-CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG001
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
Units
Counts
Participants
Secondary
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Per Protocol
Posted
Geometric Mean
95% Confidence Interval
Titers
7 months of age (one month post-infant series)
ID
Title
Description
OG000
LA1 (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG002
LA3 (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
Secondary
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Per Protocol
Posted
Number
95% Confidence Interval
Percentages of subjects
7 months of age (one month post-infant series)
ID
Title
Description
OG000
LA1 (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG002
LA3 (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
Secondary
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Per protocol was defined as subjects who:
received all the relevant doses of vaccine correctly
provided evaluable serum samples at the relevant time points
had no major protocol deviation as defined prior to database lock
Posted
Number
95% Confidence Interval
Percentages of subjects
12 Months of Age (one month pre-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Per protocol was defined as subjects who:
received all the relevant doses of vaccine correctly
provided evaluable serum samples at the relevant time points
had no major protocol deviation as defined prior to database lock
Posted
Number
95% Confidence Interval
Percentages of subjects
12 Months of Age (one month pre-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Persistence Antibodies Geometric Mean Titers - US Subject
Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
12 Months of Age (one month pre-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines )
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Units
Counts
Secondary
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
12 or 16 Months of Age (one month pre-toddler vaccination)
ID
Title
Description
OG000
LA1 (Men ACWY-CRM + Infant Vaccines) (12m)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA2 (Infant Vaccines Only) (12m)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG002
LA3 (Men ACWY-CRM + Infant Vaccines) (16m)
Secondary
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
12 or 16 Months of Age (one month pre-toddler vaccination)
ID
Title
Description
OG000
LA1 (Men ACWY-CRM + Infant Vaccines) (12m)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA2 (Infant Vaccines Only) (12m)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG002
LA3 (Men ACWY-CRM + Infant Vaccines) (16m)
Secondary
Persistence Antibodies Geometric Mean Titers - LA Subjects
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
12 or 16 Months of Age (one month pre-toddler vaccination)
ID
Title
Description
OG000
LA1 (Men ACWY-CRM + Infant Vaccines) (12m)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG001
LA2 (Infant Vaccines Only) (12m)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG002
LA3 (Men ACWY-CRM + Infant Vaccines) (16m)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
Secondary
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines )
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines )
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines )
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY- CRM + Infant Vaccines )
US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
OG001
US2 (Infant Vaccine Only)
received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
Secondary
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
13 or 17 Months of Age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA1A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG001
LA3A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
Secondary
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
13 or 17 Months of Age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA1A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG001
LA3A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
Secondary
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
13 or 17 Months of Age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA1A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG001
LA3A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
Secondary
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
13 or 17 Months of Age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA1A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG001
LA3A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
Secondary
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
Per Protocol
Posted
Geometric Mean
95% Confidence Interval
Titers
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG001
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
Units
Counts
Participants
Secondary
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
Per Protocol
Posted
Number
95% Confidence Interval
Percentages of subjects
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
US1A (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG001
US1B (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
OG002
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
Secondary
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
Per Protocol
Posted
Geometric Mean
95% Confidence Interval
Concentrations (μg/mL)
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA1A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG001
LA1B (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
Units
Secondary
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F
Per Protocol
Posted
Number
95% Confidence Interval
Percentages of subjects
13 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA1A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG001
LA1B (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
Secondary
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
Per Protocol
Posted
Geometric Mean
95% Confidence Interval
Titers
17 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA3A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
OG001
LA3B (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
Secondary
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
Per Protocol
Posted
Number
95% Confidence Interval
Percentages of subjects
17 months of age (one month post-toddler vaccination)
ID
Title
Description
OG000
LA3A (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
OG001
LA3B (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
Secondary
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Number
95% Confidence Interval
Percentages of subjects
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
ID
Title
Description
OG000
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG001
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
Secondary
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
The analysis was done on per protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
ID
Title
Description
OG000
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG001
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
US1+US3
Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
58
995
957
995
EG001
US2+US4A+US4B
Groups Infant Vaccines only (US2, US4A, and US4B) pooled.
In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)
18
301
279
301
EG002
US4C
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
14
203
202
203
EG003
LA1+LA3+LA5
Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled
LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B).
LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received:
Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A)
DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B).
Concomitantly the fourth dose of MenACWY (LA5).
173
2,026
1,946
2,026
EG004
LA2+4+6AB
Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).
84
824
795
824
EG005
LA6C
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
12
183
178
183
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG0030 affected2,026 at risk
EG0040 affected824 at risk
EG0051 affected183 at risk
LYMPHADENITIS
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
CYANOSIS
Cardiac disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PULMONARY VALVE STENOSIS
Cardiac disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ATRIAL SEPTAL DEFECT
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
FALLOT'S TETRALOGY
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HYPOSPADIAS
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
OPTIC NERVE HYPOPLASIA
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
PYLORIC STENOSIS
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HAEMATOTYMPANUM
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BLEPHARITIS
Eye disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
DIARRHOEA HAEMORRHAGIC
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
GASTRITIS
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
INTUSSUSCEPTION
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
NAUSEA
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PERITONITIS
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
STOMATITIS
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
VOMITING
Gastrointestinal disorders
Systematic Assessment
EG0001 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
OEDEMA
General disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PYREXIA
General disorders
Systematic Assessment
EG0003 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
FOOD ALLERGY
Immune system disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HYPOGAMMAGLOBULINAEMIA
Immune system disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
ABSCESS LIMB
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
ABSCESS NECK
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ABSCESS ORAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ACARODERMATITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ACUTE SINUSITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ARTHRITIS BACTERIAL
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BACTERAEMIA
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BACTERIAL DIARRHOEA
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BOTULISM
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BRONCHIOLITIS
Infections and infestations
Non-systematic Assessment
EG00010 affected995 at risk
EG0013 affected301 at risk
EG0022 affected203 at risk
EG003
BRONCHITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BRONCHITIS VIRAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BRONCHOPNEUMONIA
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
CELLULITIS
Infections and infestations
Non-systematic Assessment
EG0003 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
CROUP INFECTIOUS
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
DENGUE FEVER
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ENTERITIS INFECTIOUS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
EXANTHEMA SUBITUM
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
FEBRILE INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
GASTROENTERITIS
Infections and infestations
Non-systematic Assessment
EG0002 affected995 at risk
EG0010 affected301 at risk
EG0022 affected203 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
IMPETIGO
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
INFECTIOUS MONONUCLEOSIS
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
INFLUENZA
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
LUNG INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
OSTEOMYELITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
OTITIS MEDIA
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
OTITIS MEDIA ACUTE
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PERIORBITAL CELLULITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PERTUSSIS
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PHARYNGITIS
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PNEUMONIA
Infections and infestations
Non-systematic Assessment
EG0004 affected995 at risk
EG0012 affected301 at risk
EG0021 affected203 at risk
EG003
PNEUMONIA BACTERIAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PNEUMONIA PRIMARY ATYPICAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
PNEUMONIA VIRAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
Infections and infestations
Non-systematic Assessment
EG0004 affected995 at risk
EG0014 affected301 at risk
EG0021 affected203 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION
Infections and infestations
Non-systematic Assessment
EG0003 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SEPSIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SINUSITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
STAPHYLOCOCCAL ABSCESS
Infections and infestations
Non-systematic Assessment
EG0002 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
Non-systematic Assessment
EG0002 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
STAPHYLOCOCCAL SKIN INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SUBCUTANEOUS ABSCESS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
VARICELLA
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
VIRAL DIARRHOEA
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
VIRAL INFECTION
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
VIRAL PHARYNGITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
VULVAL ABSCESS
Infections and infestations
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ACCIDENTAL DRUG INTAKE BY CHILD
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ACCIDENTAL EXPOSURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BURNS SECOND DEGREE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
FOREIGN BODY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
LIMB TRAUMATIC AMPUTATION
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SKULL FRACTURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
TRAUMATIC BRAIN INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
UPPER LIMB FRACTURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
COW'S MILK INTOLERANCE
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
Non-systematic Assessment
EG0005 affected995 at risk
EG0011 affected301 at risk
EG0022 affected203 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
DIABETIC KETOACIDOSIS
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SYNOSTOSIS
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ACUTE MYELOID LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
BRAIN NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
COMPLEX PARTIAL SEIZURES
Nervous system disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0002 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
FEBRILE CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
GRAND MAL CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PSYCHOMOTOR SKILLS IMPAIRED
Nervous system disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SUBARACHNOID HAEMORRHAGE
Nervous system disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
TONIC CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
NEPHROTIC SYNDROME
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
APNOEA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BRONCHIAL HYPERREACTIVITY
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
CHOKING
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
FOREIGN BODY ASPIRATION
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
LARYNGOSPASM
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PULMONARY HYPERTENSION
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
RESPIRATORY DISORDER
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
SLEEP APNOEA SYNDROME
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
STATUS ASTHMATICUS
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
TACHYPNOEA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0011 affected301 at risk
EG0020 affected203 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0002 affected995 at risk
EG0010 affected301 at risk
EG0021 affected203 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
INTESTINAL OPERATION
Surgical and medical procedures
Non-systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
KAWASAKI'S DISEASE
Vascular disorders
Non-systematic Assessment
EG0001 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CONJUNCTIVITIS
Eye disorders
Non-systematic Assessment
EG00093 affected995 at risk
EG00130 affected301 at risk
EG00229 affected203 at risk
EG00368 affected2,026 at risk
EG00428 affected824 at risk
EG0059 affected183 at risk
DIARRHOEA
Gastrointestinal disorders
Systematic Assessment
EG000289 affected995 at risk
EG00191 affected301 at risk
EG00278 affected203 at risk
EG003
FLATULENCE
Gastrointestinal disorders
Non-systematic Assessment
EG00023 affected995 at risk
EG0018 affected301 at risk
EG00212 affected203 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
Non-systematic Assessment
EG00049 affected995 at risk
EG00111 affected301 at risk
EG00212 affected203 at risk
EG003
TEETHING
Gastrointestinal disorders
Non-systematic Assessment
EG00083 affected995 at risk
EG00128 affected301 at risk
EG00230 affected203 at risk
EG003
VOMITING
Gastrointestinal disorders
Systematic Assessment
EG000217 affected995 at risk
EG00169 affected301 at risk
EG00261 affected203 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
Systematic Assessment
EG000280 affected995 at risk
EG001108 affected301 at risk
EG002100 affected203 at risk
EG003
INJECTION SITE INDURATION
General disorders
Systematic Assessment
EG000204 affected995 at risk
EG001101 affected301 at risk
EG00278 affected203 at risk
EG003
INJECTION SITE PAIN
General disorders
Systematic Assessment
EG000651 affected995 at risk
EG001196 affected301 at risk
EG002147 affected203 at risk
EG003
IRRITABILITY
General disorders
Systematic Assessment
EG000800 affected995 at risk
EG001240 affected301 at risk
EG002171 affected203 at risk
EG003
MALAISE
General disorders
Systematic Assessment
EG0000 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
PYREXIA
General disorders
Systematic Assessment
EG000296 affected995 at risk
EG00194 affected301 at risk
EG00274 affected203 at risk
EG003
BRONCHIOLITIS
Infections and infestations
Non-systematic Assessment
EG000108 affected995 at risk
EG00134 affected301 at risk
EG00225 affected203 at risk
EG003
BRONCHITIS
Infections and infestations
Non-systematic Assessment
EG00010 affected995 at risk
EG0016 affected301 at risk
EG0025 affected203 at risk
EG003
CROUP INFECTIOUS
Infections and infestations
Non-systematic Assessment
EG00044 affected995 at risk
EG00112 affected301 at risk
EG00215 affected203 at risk
EG003
GASTROENTERITIS
Infections and infestations
Non-systematic Assessment
EG00049 affected995 at risk
EG00118 affected301 at risk
EG0026 affected203 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
Non-systematic Assessment
EG00041 affected995 at risk
EG0019 affected301 at risk
EG00211 affected203 at risk
EG003
OTITIS MEDIA
Infections and infestations
Non-systematic Assessment
EG000258 affected995 at risk
EG00176 affected301 at risk
EG00262 affected203 at risk
EG003
OTITIS MEDIA ACUTE
Infections and infestations
Non-systematic Assessment
EG00042 affected995 at risk
EG00115 affected301 at risk
EG00213 affected203 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0002 affected995 at risk
EG0010 affected301 at risk
EG0020 affected203 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG000340 affected995 at risk
EG001108 affected301 at risk
EG00274 affected203 at risk
EG003
VIRAL INFECTION
Infections and infestations
Non-systematic Assessment
EG00082 affected995 at risk
EG00122 affected301 at risk
EG00220 affected203 at risk
EG003
CRYING
Nervous system disorders
Systematic Assessment
EG000558 affected995 at risk
EG001154 affected301 at risk
EG002124 affected203 at risk
EG003
SOMNOLENCE
Nervous system disorders
Non-systematic Assessment
EG000676 affected995 at risk
EG001184 affected301 at risk
EG002141 affected203 at risk
EG003
EATING DISORDERS
Psychiatric disorders
Systematic Assessment
EG000425 affected995 at risk
EG001122 affected301 at risk
EG00293 affected203 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00015 affected995 at risk
EG0010 affected301 at risk
EG0023 affected203 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00064 affected995 at risk
EG00120 affected301 at risk
EG00215 affected203 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00060 affected995 at risk
EG00115 affected301 at risk
EG00218 affected203 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00029 affected995 at risk
EG0019 affected301 at risk
EG00213 affected203 at risk
EG003
DERMATITIS DIAPER
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00062 affected995 at risk
EG00121 affected301 at risk
EG00213 affected203 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG000105 affected995 at risk
EG00132 affected301 at risk
EG00221 affected203 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
Systematic Assessment
EG000154 affected995 at risk
EG00133 affected301 at risk
EG00239 affected203 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D008585
Meningitis, Meningococcal
D008581
Meningitis
D008589
Meningococcal Infections
Ancestor Terms
ID
Term
D016920
Meningitis, Bacterial
D020806
Central Nervous System Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D002494
Central Nervous System Infections
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D000090862
Neuroinflammatory Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D022401
Meningococcal Vaccines
C541235
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
C472675
PEDIARIX
D013745
Tetanus Toxoid
D017325
Hepatitis B Vaccines
C055753
Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
D022242
Pneumococcal Vaccines
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
D022362
Hepatitis A Vaccines
C050102
measles, mumps, rubella, varicella vaccine
D019433
Chickenpox Vaccine
D022681
Diphtheria-Tetanus-acellular Pertussis Vaccines
Ancestor Terms
ID
Term
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D014121
Toxoids
D014761
Viral Hepatitis Vaccines
D014765
Viral Vaccines
D022541
Streptococcal Vaccines
D017778
Vaccines, Combined
D022283
Herpesvirus Vaccines
D010567
Pertussis Vaccine
D004168
Diphtheria Toxoid
D022282
Vaccines, Acellular
D022223
Vaccines, Subunit
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0151 subjects
FG0160 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0133 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0132 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
11 subjects
FG0055 subjects
FG0068 subjects
FG0071 subjects
FG0080 subjects
FG0096 subjects
FG0102 subjects
FG0114 subjects
FG0126 subjects
FG01374 subjects
FG01429 subjects
FG0154 subjects
FG0165 subjects
3 subjects
FG0051 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0094 subjects
FG0102 subjects
FG0112 subjects
FG0124 subjects
FG01319 subjects
FG0149 subjects
FG0156 subjects
FG0162 subjects
3 subjects
FG0052 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0093 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG01320 subjects
FG01412 subjects
FG0156 subjects
FG0161 subjects
38 subjects
FG0056 subjects
FG00612 subjects
FG0074 subjects
FG0084 subjects
FG00913 subjects
FG0105 subjects
FG0114 subjects
FG0124 subjects
FG01337 subjects
FG01422 subjects
FG0151 subjects
FG0161 subjects
65.0
± 6.0
BG00466.1± 6.2
BG00565.0± 6.5
BG00665.9± 6.5
BG00768.0± 7.7
BG00868.6± 8.9
BG00967.8± 8.3
BG01067.0± 7.9
BG01168.4± 8.7
BG01267.5± 8.0
BG01365.0± 9.4
BG01467.7± 9.7
BG01559.5± 6.2
BG01665.0± 7.9
BG01765.7± 8.3
71
BG003340
BG00439
BG00529
BG006103
BG00779
BG00882
BG00972
BG01072
BG01175
BG01281
BG013682
BG014178
BG01589
BG01691
BG0172223
Male
BG00086
BG00194
BG00288
BG003340
BG00437
BG00541
BG006100
BG00772
BG00868
BG00976
BG01079
BG01175
BG01269
BG013744
BG014180
BG01581
BG01692
BG0172322
98
(92 to 100)
OG00190(81 to 96)
W (85, 73)
Title
Measurements
OG000100(96 to 100)
OG00158(45 to 69)
Y (84, 68)
Title
Measurements
OG000100(96 to 100)
OG00156(43 to 68)
OG002
US1 (MenACWY-CRM + Infant Vaccines)
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG003
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG004
US3 (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG005
US4 (Infant Vaccines Only )
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
OG006
LA1 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG007
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG008
LA3 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
OG009
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
OG010
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
OG011
LA6 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
Units
Counts
Participants
OG000153
OG001165
OG002318
OG003159
OG004677
OG005345
OG006301
OG007148
OG008301
OG009150
OG0101424
OG011709
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG00010
OG00117
OG00227
OG00323
OG00466
OG00554
OG00686
OG00762
OG00886
OG00965
OG010542
OG011273
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Induration (mm) - Any
Title
Measurements
OG00010
OG00114
OG00224
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tenderness - Any
Title
Measurements
OG00064
OG00176
OG002140
OG003
Tenderness - Severe
Title
Measurements
OG0003
OG0014
OG0027
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG00013
OG0016
OG00219
OG003
Change in Eating Habits - Any
Title
Measurements
OG00042
OG00146
OG00288
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0001
OG0011
OG0022
OG003
Diarrhea - Any
Title
Measurements
OG00024
OG00123
OG00247
OG003
Diarrhea - Severe
Title
Measurements
OG0002
OG0010
OG0022
OG003
Irritability - Any
Title
Measurements
OG00082
OG001107
OG002189
OG003
Irritability - Severe
Title
Measurements
OG0006
OG0012
OG0028
OG003
Persistent Crying - Any
Title
Measurements
OG00043
OG00174
OG002117
OG003
Persistent Crying - Severe
Title
Measurements
OG0001
OG0012
OG0023
OG003
Rash - Any
Title
Measurements
OG0006
OG0019
OG00215
OG003
Rash - Severe
Title
Measurements
OG0003
OG0014
OG0027
OG003
Sleepiness - Any
Title
Measurements
OG00083
OG001104
OG002187
OG003
Sleepiness - Severe
Title
Measurements
OG0002
OG0013
OG0025
OG003
Vomiting - Any
Title
Measurements
OG00015
OG00118
OG00233
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG000105
OG001120
OG002225
OG003
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG003
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG004
US3 (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG005
US4 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
OG006
LA3 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
OG007
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
OG008
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
OG009
LA6 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
Units
Counts
Participants
OG000141
OG001150
OG002291
OG003151
OG004645
OG005325
OG006301
OG007150
OG0081424
OG009709
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG00014
OG00119
OG00233
OG00335
OG00475
OG00560
OG00692
OG00745
OG008583
OG009311
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Induration (mm) - Any
Title
Measurements
OG00016
OG00116
OG00232
OG003
Induration (mm) - Severe
Title
Measurements
OG0001
OG0010
OG0021
OG003
Tenderness - Any
Title
Measurements
OG00059
OG00159
OG002118
OG003
Tenderness - Severe
Title
Measurements
OG0001
OG0010
OG0021
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG00017
OG0016
OG00223
OG003
Change in Eating Habits - Any
Title
Measurements
OG00025
OG00121
OG00246
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diarrhea - Any
Title
Measurements
OG00016
OG00110
OG00226
OG003
Diarrhea - Severe
Title
Measurements
OG0000
OG0011
OG0021
OG003
Irritability - Any
Title
Measurements
OG00083
OG00180
OG002163
OG003
Irritability - Severe
Title
Measurements
OG0002
OG0010
OG0022
OG003
Persistent Crying - Any
Title
Measurements
OG00042
OG00141
OG00283
OG003
Persistent Crying - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash - Any
Title
Measurements
OG0003
OG0015
OG0028
OG003
Rash - Severe
Title
Measurements
OG0003
OG0011
OG0024
OG003
Sleepiness - Any
Title
Measurements
OG00069
OG00156
OG002125
OG003
Sleepiness - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vomiting - Any
Title
Measurements
OG0008
OG0019
OG00217
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG00094
OG00191
OG002185
OG003
Units
Counts
Participants
OG00086
OG00174
Title
Denominators
Categories
A Pre-vaccination (84, 74)
Title
Measurements
OG0002.51(2.14 to 2.96)
OG0012.14(1.8 to 2.54)
A Post-vaccination (84, 74)
Title
Measurements
OG00077(55 to 109)
OG00117(12 to 25)
C Pre-vaccination (86, 73)
Title
Measurements
OG0007.72(5.9 to 10)
OG0012.26(1.69 to 3.03)
C Post-vaccination (86, 73)
Title
Measurements
OG000227(155 to 332)
OG00135(23 to 54)
W Pre-vaccination (85, 73)
Title
Measurements
OG00014(11 to 18)
OG0012.21(1.69 to 2.9)
W Post-vaccination (85, 73)
Title
Measurements
OG000416(288 to 602)
OG00111(7.59 to 17)
Y Pre-vaccination (84, 68)
Title
Measurements
OG00011(8.76 to 15)
OG0012.14(1.6 to 2.86)
Y Post-vaccination (84, 68)
Title
Measurements
OG000395(269 to 580)
OG00110(6.72 to 16)
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
Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.
ANOVA
Ratio of GMTs
4.53
2-Sided
95
3.04
6.74
A (Post-vaccination GMT; group ratio US1A:US2)
No
Superiority or Other
OG000
OG001
Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.
ANOVA
Ratio of GMTs
6.39
2-Sided
95
4.16
9.79
C (Post-vaccination GMT; group ratio US1A:US2)
No
Superiority or Other
OG000
OG001
Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.
ANOVA
Ratio of GMTs
37
2-Sided
95
24
58
W (Post-vaccination GMT; group ratio US1A:US2)
No
Superiority or Other
OG000
OG001
Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.
Ratio of GMTs
ANOVA
Ratio of GMTs
38
2-Sided
95
24
60
Y (Post-vaccination GMT; group ratio US1A:US2)
No
Superiority or Other
US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
OG003
US2 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG004
US3 (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG005
US4 (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
OG006
LA1 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
OG007
LA2 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG008
LA3 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
OG009
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
OG010
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
OG011
LA6 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
Units
Counts
Participants
OG000138
OG001145
OG002283
OG003143
OG004627
OG005311
OG006297
OG007131
OG008290
OG009147
OG0101357
OG011679
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG00016
OG00118
OG00234
OG00328
OG00492
OG00567
OG00669
OG00727
OG00864
OG00938
OG010485
OG011273
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Induration (mm) - Any
Title
Measurements
OG00015
OG00115
OG00230
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tenderness - Any
Title
Measurements
OG00037
OG00145
OG00282
OG003
Tenderness - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG0004
OG0019
OG00213
OG003
Change in Eating Habits - Any
Title
Measurements
OG00019
OG00122
OG00241
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diarrhea - Any
Title
Measurements
OG00013
OG0019
OG00222
OG003
Diarrhea - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Irritability - Any
Title
Measurements
OG00058
OG00173
OG002131
OG003
Irritability - Severe
Title
Measurements
OG0001
OG0011
OG0022
OG003
Persistent Crying - Any
Title
Measurements
OG00028
OG00126
OG00254
OG003
Persistent Crying - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash - Any
Title
Measurements
OG0002
OG0019
OG00211
OG003
Rash - Severe
Title
Measurements
OG0001
OG0014
OG0025
OG003
Sleepiness - Any
Title
Measurements
OG00037
OG00141
OG00278
OG003
Sleepiness - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vomiting - Any
Title
Measurements
OG0006
OG0016
OG00212
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG00075
OG00182
OG002157
OG003
Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
OG003
US2 + US4A (Infant Vaccines Only)
Groups Infant Vaccines only (US2 and US4A) pooled.
In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG004
US3 (MenACWY-CRM + Infant Vaccines)
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG005
US4B + US4C (Infant Vaccines Only)
Groups Infant Vaccines only (US4B and US4C) pooled.
Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C).
OG006
LA1A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG007
LA1B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
OG008
LA2 + LA4 + LA6A (Infant Vaccines Only)
Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG009
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
OG010
LA6B + LA6C (Infant Vaccines Only)
Groups Infant Vaccines only LA6B and LA6C pooled.
Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C).
Units
Counts
Participants
OG000122
OG001124
OG002704
OG003137
OG004582
OG005261
OG006145
OG007143
OG008564
OG0091275
OG010349
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG00011
OG00116
OG00281
OG00318
OG00470
OG00549
OG00636
OG00733
OG008166
OG009309
OG01067
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0022
OG003
Induration (mm) - Any
Title
Measurements
OG00010
OG00113
OG00244
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tenderness - Any
Title
Measurements
OG00028
OG00131
OG002177
OG003
Tenderness - Severe
Title
Measurements
OG0000
OG0010
OG0022
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG00014
OG00110
OG00249
OG003
Change in Eating Habits - Any
Title
Measurements
OG00021
OG00117
OG002101
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0001
OG0012
OG0027
OG003
Diarrhea - Any
Title
Measurements
OG0005
OG00114
OG00261
OG003
Diarrhea - Severe
Title
Measurements
OG0000
OG0010
OG0024
OG003
Irritability - Any
Title
Measurements
OG00053
OG00153
OG002271
OG003
Irritability - Severe
Title
Measurements
OG0002
OG0012
OG0028
OG003
Persistent Crying - Any
Title
Measurements
OG00021
OG00121
OG002120
OG003
Persistent Crying - Severe
Title
Measurements
OG0000
OG0010
OG0026
OG003
Rash - Any
Title
Measurements
OG0008
OG0014
OG00231
OG003
Rash - Severe
Title
Measurements
OG0001
OG0011
OG0023
OG003
Sleepiness - Any
Title
Measurements
OG00038
OG00129
OG002149
OG003
Sleepiness - Severe
Title
Measurements
OG0000
OG0011
OG0023
OG003
Vomiting - Any
Title
Measurements
OG0006
OG0014
OG00227
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0010
OG0021
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG00060
OG00156
OG002320
OG003
Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG003
US4B (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
OG004
US4C (Infant Vaccines Only)
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
OG005
LA1A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
OG006
LA1B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
OG007
LA2 + LA4 + LA6A (Infant Vaccines Only)
Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG008
LA3A (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
OG009
LA3B (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
OG010
LA5 (MenACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
OG011
LA6B (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
OG012
LA6C (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
Units
Counts
Participants
OG000120
OG001704
OG002136
OG00359
OG004179
OG005145
OG006143
OG007564
OG008142
OG009137
OG0101275
OG011160
OG012175
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG0007
OG00181
OG00218
OG0039
OG00428
OG00536
OG00617
OG007166
OG00836
OG00919
OG010309
OG01124
OG01252
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0012
OG0021
OG003
Induration (mm) - Any
Title
Measurements
OG0001
OG00144
OG00212
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tenderness - Any
Title
Measurements
OG00016
OG001177
OG00238
OG003
Tenderness - Severe
Title
Measurements
OG0000
OG0012
OG0020
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG0005
OG00149
OG00212
OG003
Change in Eating Habits - Any
Title
Measurements
OG0009
OG001101
OG00220
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0000
OG0017
OG0021
OG003
Diarrhea - Any
Title
Measurements
OG0008
OG00161
OG00216
OG003
Diarrhea - Severe
Title
Measurements
OG0000
OG0014
OG0021
OG003
Irritability - Any
Title
Measurements
OG00039
OG001271
OG00262
OG003
Irritability - Severe
Title
Measurements
OG0001
OG0018
OG0024
OG003
Persistent Crying - Any
Title
Measurements
OG00016
OG001120
OG00224
OG003
Persistent Crying - Severe
Title
Measurements
OG0000
OG0016
OG0021
OG003
Rash - Any
Title
Measurements
OG0001
OG00131
OG0025
OG003
Rash - Severe
Title
Measurements
OG0000
OG0013
OG0023
OG003
Sleepiness - Any
Title
Measurements
OG00025
OG001149
OG00222
OG003
Sleepiness - Severe
Title
Measurements
OG0001
OG0013
OG0021
OG003
Vomiting - Any
Title
Measurements
OG0002
OG00127
OG0028
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0011
OG0020
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG00037
OG001320
OG00277
OG003
LA2 + LA4 + LA6A (Infant Vaccines Only)
Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
OG003
LA6B (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
Units
Counts
Participants
OG000120
OG00155
OG002539
OG003153
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG00014
OG0016
OG002143
OG00328
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0011
OG0022
OG003
Induration (mm) - Any
Title
Measurements
OG00010
OG0012
OG00251
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0011
OG0021
OG003
Tenderness - Any
Title
Measurements
OG00019
OG00116
OG002128
OG003
Tenderness - Severe
Title
Measurements
OG0000
OG0010
OG0025
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG0005
OG0011
OG00230
OG003
Change in Eating Habits - Any
Title
Measurements
OG0007
OG0012
OG00218
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diarrhea - Any
Title
Measurements
OG0004
OG0013
OG00228
OG003
Diarrhea - Severe
Title
Measurements
OG0001
OG0010
OG0021
OG003
Irritability - Any
Title
Measurements
OG00031
OG00122
OG00271
OG003
Irritability - Severe
Title
Measurements
OG0000
OG0010
OG0022
OG003
Persistent Crying - Any
Title
Measurements
OG0009
OG00110
OG00237
OG003
Persistent Crying - Severe
Title
Measurements
OG0000
OG0010
OG0023
OG003
Rash - Any
Title
Measurements
OG0004
OG0011
OG0029
OG003
Rash - Severe
Title
Measurements
OG0000
OG0010
OG0024
OG003
Sleepiness - Any
Title
Measurements
OG00012
OG0018
OG00236
OG003
Sleepiness - Severe
Title
Measurements
OG0000
OG0010
OG0021
OG003
Vomiting - Any
Title
Measurements
OG0005
OG0012
OG00212
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG00040
OG00114
OG00285
OG003
OG002
LA3 + LA5 (Men ACWY-CRM + Infant Vaccines)
Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled.
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:
Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)
Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).
Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5).
OG003
LA4 + LA6 (Infant Vaccines Only)
Groups Infant Vaccines only (LA4 and LA6) pooled.
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C).
Units
Counts
Participants
OG000989
OG001503
OG0021724
OG003859
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG00093
OG00177
OG002628
OG003338
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0016
OG0022
OG003
Induration (mm) - Any
Title
Measurements
OG00085
OG00169
OG002321
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0011
OG0022
OG003
Tenderness - Any
Title
Measurements
OG000464
OG001230
OG0021086
OG003
Tenderness - Severe
Title
Measurements
OG00032
OG00125
OG002114
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG00051
OG00128
OG002229
OG003
Change in Eating Habits - Any
Title
Measurements
OG000259
OG001130
OG002294
OG003
Change in Eating Habits - Severe
Title
Measurements
OG00010
OG0013
OG0026
OG003
Diarrhea - Any
Title
Measurements
OG000154
OG00163
OG002266
OG003
Diarrhea - Severe
Title
Measurements
OG0005
OG0012
OG0023
OG003
Irritability - Any
Title
Measurements
OG000608
OG001307
OG002607
OG003
Irritability - Severe
Title
Measurements
OG00032
OG00116
OG00226
OG003
Persistent Crying - Any
Title
Measurements
OG000369
OG001174
OG002566
OG003
Persistent Crying - Severe
Title
Measurements
OG00014
OG00113
OG00240
OG003
Rash - Any
Title
Measurements
OG00031
OG00116
OG002110
OG003
Rash - Severe
Title
Measurements
OG00011
OG0016
OG00258
OG003
Sleepiness - Any
Title
Measurements
OG000541
OG001249
OG002820
OG003
Sleepiness - Severe
Title
Measurements
OG00019
OG0013
OG00227
OG003
Vomiting - Any
Title
Measurements
OG000100
OG00150
OG002244
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0011
OG0023
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG000672
OG001333
OG0021155
OG003
OG002
LA3+LA5 (Men ACWY-CRM + Infant Vaccines)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:
Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)
Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).
Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5).
OG003
LA4+LA6 (Infant Vaccines Only)
Groups Infant Vaccines only (LA4 and LA6) pooled.
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C).
Units
Counts
Participants
OG000936
OG001476
OG0021672
OG003824
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG000108
OG00195
OG002675
OG003356
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0012
OG0020
OG003
Induration (mm) - Any
Title
Measurements
OG00077
OG00175
OG002267
OG003
Induration (mm) - Severe
Title
Measurements
OG0001
OG0013
OG0020
OG003
Tenderness - Any
Title
Measurements
OG000348
OG001193
OG002841
OG003
Tenderness - Severe
Title
Measurements
OG00014
OG00113
OG00262
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG00072
OG00143
OG002246
OG003
Change in Eating Habits - Any
Title
Measurements
OG000168
OG00184
OG002188
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0003
OG0010
OG0029
OG003
Diarrhea - Any
Title
Measurements
OG00079
OG00146
OG002177
OG003
Diarrhea - Severe
Title
Measurements
OG0002
OG0013
OG0025
OG003
Irritability - Any
Title
Measurements
OG000505
OG001265
OG002496
OG003
Irritability - Severe
Title
Measurements
OG00016
OG00112
OG00216
OG003
Persistent Crying - Any
Title
Measurements
OG000261
OG001141
OG002336
OG003
Persistent Crying - Severe
Title
Measurements
OG0005
OG0014
OG00218
OG003
Rash - Any
Title
Measurements
OG00032
OG00117
OG002110
OG003
Rash - Severe
Title
Measurements
OG00010
OG0015
OG00257
OG003
Sleepiness - Any
Title
Measurements
OG000363
OG001178
OG002547
OG003
Sleepiness - Severe
Title
Measurements
OG0003
OG0013
OG00217
OG003
Vomiting - Any
Title
Measurements
OG00066
OG00134
OG002156
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0011
OG0024
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG000570
OG001297
OG002988
OG003
OG002
LA3+LA5 (Men ACWY-CRM + Infant Vaccines)
Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:
Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)
Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).
Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5).
OG003
LA4+LA6 (Infant Vaccines Only)
Groups Infant Vaccines only (LA4 and LA6) pooled.
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C).
Units
Counts
Participants
OG000910
OG001454
OG0021646
OG003826
Title
Denominators
Categories
Erythema (mm) - Any
Title
Measurements
OG000126
OG00195
OG002549
OG003311
Erythema (mm) - Severe
Title
Measurements
OG0000
OG0012
OG0022
OG003
Induration (mm) - Any
Title
Measurements
OG00089
OG00182
OG002189
OG003
Induration (mm) - Severe
Title
Measurements
OG0000
OG0013
OG0021
OG003
Tenderness - Any
Title
Measurements
OG000271
OG001137
OG002582
OG003
Tenderness - Severe
Title
Measurements
OG0001
OG0018
OG00223
OG003
Body Temp. ( >= 38° C )
Title
Measurements
OG00046
OG00134
OG002190
OG003
Change in Eating Habits - Any
Title
Measurements
OG000135
OG00157
OG002149
OG003
Change in Eating Habits - Severe
Title
Measurements
OG0003
OG0013
OG0026
OG003
Diarrhea - Any
Title
Measurements
OG00063
OG00135
OG002109
OG003
Diarrhea - Severe
Title
Measurements
OG0002
OG0011
OG0022
OG003
Irritability - Any
Title
Measurements
OG000416
OG001227
OG002373
OG003
Irritability - Severe
Title
Measurements
OG0006
OG0016
OG0027
OG003
Persistent Crying - Any
Title
Measurements
OG000189
OG00198
OG002208
OG003
Persistent Crying - Severe
Title
Measurements
OG0004
OG0014
OG00211
OG003
Rash - Any
Title
Measurements
OG00025
OG00112
OG00268
OG003
Rash - Severe
Title
Measurements
OG0007
OG0014
OG00232
OG003
Sleepiness - Any
Title
Measurements
OG000257
OG001130
OG002362
OG003
Sleepiness - Severe
Title
Measurements
OG0006
OG0011
OG0027
OG003
Vomiting - Any
Title
Measurements
OG00043
OG00129
OG002115
OG003
Vomiting - Severe
Title
Measurements
OG0000
OG0011
OG0022
OG003
Analgesic / Antipyretic medication used
Title
Measurements
OG000506
OG001274
OG002682
OG003
OG000212
OG00190
Title
Denominators
Categories
A (Pre-vaccination GMT; N= 177, 65)
Title
Measurements
OG0002.11(2 to 2.23)
OG0012.1(1.92 to 2.29)
A (Post-vaccination GMT; N= 212, 80)
Title
Measurements
OG00013(11 to 16)
OG0012.03(1.53 to 2.7)
C (Pre-vaccination GMT; N= 168, 64)
Title
Measurements
OG0002.48(2.23 to 2.75)
OG0012.17(1.83 to 2.57)
C (Post-vaccination GMT; N= 204, 84)
Title
Measurements
OG000108(92 to 127)
OG0012.12(1.64 to 2.74)
W (Pre-vaccination GMT; N= 165, 66)
Title
Measurements
OG0003.07(2.7 to 3.5)
OG0012.71(2.2 to 3.33)
W (Post-vaccination GMT; N=197, 90)
Title
Measurements
OG000100(86 to 116)
OG0012.08(1.67 to 2.6)
Y (Pre-vaccination GMT; N=150, 62 )
Title
Measurements
OG0002.53(2.31 to 2.77)
OG0012.13(1.85 to 2.45)
Y (Post-vaccination GMT; N=182, 84)
Title
Measurements
OG00073(62 to 86)
OG0012.03(1.6 to 2.57)
OG000277
OG001272
Title
Denominators
Categories
A (Pre-vaccination GMT; N= 272, 271)
Title
Measurements
OG0002.09(2.03 to 2.16)
OG0012.03(1.97 to 2.09)
A (Post-vaccination GMT; N= 277, 268)
Title
Measurements
OG00031(26 to 38)
OG00143(36 to 52)
C (Pre-vaccination GMT; N= 273,272)
Title
Measurements
OG0002.32(2.18 to 2.47)
OG0012.34(2.19 to 2.49)
C (Post-vaccination GMT; N= 277, 272)
Title
Measurements
OG000155(131 to 183)
OG001150(127 to 177)
W (Pre-vaccination GMT; N= 263, 261)
Title
Measurements
OG0002.9(2.64 to 3.18)
OG0012.54(2.31 to 2.79)
W (Post-vaccination GMT; N=271,264)
Title
Measurements
OG000259(227 to 296)
OG001182(159 to 208)
Y (Pre-vaccination GMT; N=258, 260)
Title
Measurements
OG0002.35(2.22 to 2.49)
OG0012.26(2.14 to 2.39)
Y (Post-vaccination GMT; N=272,263)
Title
Measurements
OG000159(136 to 185)
OG001125(107 to 146)
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
Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)
ANOVA
Ratio of GMT
0.73
2-Sided
95
0.55
0.95
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.
OG000
OG001
Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)
ANOVA
Ratio of GMTs
1.03
2-Sided
95
0.81
1.31
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.
OG000
OG001
Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)
ANOVA
Ratio of GMTs
1.42
2-Sided
95
1.18
1.72
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.
OG000
OG001
Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)
ANOVA
Ratio of GMTs
1.27
2-Sided
95
1.02
1.58
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.
Participants
OG000212
OG00190
Title
Denominators
Categories
A (Pre-vaccination GMT; N= 177, 65)
Title
Measurements
OG0002(0 to 5)
OG0013(0 to 11)
A (Post-vaccination GMT; N= 212, 80)
Title
Measurements
OG00067(61 to 74)
OG0011(0.032 to 7)
C (Pre-vaccination GMT; N= 168, 64)
Title
Measurements
OG0007(3 to 11)
OG0015(1 to 13)
C (Post-vaccination GMT; N= 204, 84)
Title
Measurements
OG00097(93 to 99)
OG0011(0.03 to 6)
W (Pre-vaccination GMT; N= 165, 66)
Title
Measurements
OG00017(12 to 24)
OG00111(4 to 21)
W (Post-vaccination GMT; N=197, 90)
Title
Measurements
OG00096(93 to 99)
OG0012(0 to 8)
Y (Pre-vaccination GMT; N=150, 62 )
Title
Measurements
OG0005(2 to 10)
OG0013(0 to 11)
Y (Post-vaccination GMT; N=182, 84)
Title
Measurements
OG00096(92 to 98)
OG0010(0 to 4)
Participants
OG000212
OG00190
Title
Denominators
Categories
A (Pre-vaccination GMT; N= 177, 65)
Title
Measurements
OG0002(1 to 6)
OG0013(0 to 11)
A (Post-vaccination GMT; N= 212, 80)
Title
Measurements
OG00071(65 to 77)
OG0011(0.03 to 7)
C (Pre-vaccination GMT; N= 168, 64)
Title
Measurements
OG00010(6 to 16)
OG0015(1 to 13)
C (Post-vaccination GMT; N= 204, 84)
Title
Measurements
OG00099(96 to 100)
OG0012(0 to 8)
W (Pre-vaccination GMT; N= 165, 66)
Title
Measurements
OG00022(16 to 30)
OG00115(8 to 26)
W (Post-vaccination GMT; N=197, 90)
Title
Measurements
OG00099(96 to 100)
OG0012(0 to 8)
Y (Pre-vaccination GMT; N=150, 62 )
Title
Measurements
OG00017(11 to 24)
OG0015(1 to 13)
Y (Post-vaccination GMT; N=182, 84)
Title
Measurements
OG00098(98 to 100)
OG0011(0.032 to 6)
OG000277
OG001272
Title
Denominators
Categories
A (Pre-vaccination hSBA titer ≥1:8; N= 272, 271)
Title
Measurements
OG0001(0 to 4)
OG0010(0 to 2)
A (Post-vaccination hSBA titer ≥1:8; N= 277, 268)
Title
Measurements
OG00074(69 to 79)
OG00189(85 to 93)
C (Pre-vaccination hSBA titer ≥1:8; N= 273,272)
Title
Measurements
OG0004(2 to 7)
OG0014(2 to 8)
C (Post-vaccination hSBA titer ≥1:8; N= 277, 272)
Title
Measurements
OG00094(90 to 96)
OG00197(94 to 99)
W (Pre-vaccination hSBA titer ≥1:8; N= 263, 261)
Title
Measurements
OG00016(12 to 21)
OG00110(7 to 14)
W (Post-vaccination hSBA titer ≥1:8; N=271,264)
Title
Measurements
OG00099(97 to 100)
OG00198(96 to 100)
Y (Pre-vaccination hSBA titer ≥1:8; N=258, 260)
Title
Measurements
OG0005(3 to 9)
OG0013(2 to 6)
Y (Post-vaccination hSBA titer ≥1:8; N=272,263)
Title
Measurements
OG00097(94 to 99)
OG00198(96 to 99)
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
Serogroup A (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))
ANOVA
Percentage (hSBA titers >=8) difference
-15
2-Sided
95
-21.2
-8.5
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.
OG000
OG001
Serogroup C (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))
ANOVA
Percentage (hSBA titers >=8) difference
-3
2-Sided
95
-7
0.3
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.
OG000
OG001
Serogroup W (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))
ANOVA
Percentage (hSBA titers >=8) difference
1
2-Sided
95
-1.3
3.1
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.
OG000
OG001
Serogroup Y (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))
ANOVA
Percentage (hSBA titers >=8) difference
-1
2-Sided
95
-4
1.7
Yes
Non-Inferiority or Equivalence
LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.
OG000277
OG001272
Title
Denominators
Categories
A (Pre-vaccination hSBA titer ≥1:4; N= 272, 271)
Title
Measurements
OG0002(1 to 5)
OG0011(0 to 3)
A (Post-vaccination hSBA titer ≥1:4; N= 277, 268)
Title
Measurements
OG00078(73 to 83)
OG00191(87 to 94)
C (Pre-vaccination hSBA titer ≥1:4; N= 273,272)
Title
Measurements
OG00010(7 to 14)
OG00110(7 to 15)
C (Post-vaccination hSBA titer ≥1:4; N= 277, 272)
Title
Measurements
OG00096(93 to 98)
OG00198(96 to 99)
W (Pre-vaccination hSBA titer ≥1:4; N= 263, 261)
Title
Measurements
OG00017(13 to 23)
OG00113(9 to 17)
W (Post-vaccination hSBA titer ≥1:4; N=271,264)
Title
Measurements
OG000100(99 to 100)
OG00199(97 to 100)
Y (Pre-vaccination hSBA titer ≥1:4; N=258, 260)
Title
Measurements
OG00011(8 to 16)
OG0018(5 to 13)
Y (Post-vaccination hSBA titer ≥1:4; N=272,263)
Title
Measurements
OG00098(96 to 99)
OG00199(97 to 100)
OG000214
OG001102
Title
Denominators
Categories
Diphtheria (214, 102)
Title
Measurements
OG0002.52(2.28 to 2.78)
OG0012.88(2.5 to 3.32)
Tetanus (214, 102)
Title
Measurements
OG0002.5(2.28 to 2.74)
OG0012.31(2.01 to 2.64)
PT (174, 83)
Title
Measurements
OG00054(48 to 62)
OG00154(44 to 66)
FHA (174, 83)
Title
Measurements
OG000118(106 to 132)
OG001114(97 to 134)
Pertactin (174, 83)
Title
Measurements
OG000114(100 to 130)
OG001110(90 to 134)
Polio Type 1 (176, 98)
Title
Measurements
OG000422(363 to 491)
OG001441(361 to 540)
Polio Type 2 (175, 98)
Title
Measurements
OG000348(297 to 408)
OG001290(235 to 358)
Polio Type 3 (176, 98)
Title
Measurements
OG000733(607 to 885)
OG001635(493 to 818)
Hepatitis B (N=148, N=98)
Title
Measurements
OG0001863(1538 to 2257)
OG0012112(1668 to 2674)
Hib (N=213, N=101)
Title
Measurements
OG0004.64(3.9 to 5.53)
OG0013.56(2.77 to 4.58)
PnC 4 (N=181, N=102)
Title
Measurements
OG0001.67(1.5 to 1.86)
OG0012(1.73 to 2.3)
PnC 6B (N=181, N=102)
Title
Measurements
OG0001.94(1.61 to 2.34)
OG0012.55(1.99 to 3.27)
PnC 9V (N=181, N=102)
Title
Measurements
OG0001.83(1.62 to 2.06)
OG0012.15(1.83 to 2.53)
PnC 14 (N=181, N=102)
Title
Measurements
OG0006.97(6.18 to 7.86)
OG0016.79(5.78 to 7.96)
PnC 18C (N=181, N=102)
Title
Measurements
OG0001.96(1.75 to 2.19)
OG0012.54(2.18 to 2.95)
PnC 19F (N=181, N=102)
Title
Measurements
OG0002.24(2.02 to 2.48)
OG0012.73(2.39 to 3.13)
PnC 23F (N=181, N=102)
Title
Measurements
OG0001.71(1.47 to 1.98)
OG0012.15(1.76 to 2.62)
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
Diphtheria (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.87
2-Sided
95
0.74
1.04
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
Tetanus (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
1.08
2-Sided
95
0.92
1.28
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PT (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
1
2-Sided
95
0.79
1.26
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
FHA (Post-vaccination GMT; group ratio US1:US2)
Ratio of GMTs
1.03
2-Sided
95
0.85
1.25
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
Pertactin (Post-vaccination GMT; group ratio US1:US2
ANOVA
Ratio of GMTs
1.04
2-Sided
95
0.83
1.32
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.96
2-Sided
95
0.75
1.23
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
1.2
2-Sided
95
0.93
1.55
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
1.15
2-Sided
95
0.85
1.56
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
Hepatitis B (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.88
95
0.65
1.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
HIb (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
1.31
2-Sided
95
0.97
1.77
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 4 (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.84
2-Sided
95
0.7
1
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 6B (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.76
2-Sided
95
0.56
1.03
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 9V (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.85
95
0.7
1.04
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 14 (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
1.03
2-Sided
95
0.84
1.26
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 18C (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.77
2-Sided
95
0.64
0.93
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 19F (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.82
2-Sided
95
0.69
0.97
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
OG000
OG001
PnC 23F (Post-vaccination GMT; group ratio US1:US2)
ANOVA
Ratio of GMTs
0.79
2-Sided
95
0.62
1.02
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
OG000
OG001
Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))
ANOVA
Seroconversion Percentage difference
-1
2-Sided
95
-3
3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
OG000
OG001
Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))
ANOVA
Seroconversion Percentage difference
0
2-Sided
95
-2
4
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
OG000
OG001
Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))
ANOVA
Seroconversion Percentage difference
-1
2-Sided
95
-3
3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.
OG003
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
Units
Counts
Participants
OG000287
OG001123
OG002283
OG003137
Title
Denominators
Categories
Diphtheria (N=287, N=123, N=283, N=137)
Title
Measurements
OG0001.8(1.62 to 1.99)
OG0011.54(1.32 to 1.81)
OG0021.45(1.31 to 1.61)
OG0031.77(1.52 to 2.05)
Tetanus (N=287, N=123, N=283, N=137)
Title
Measurements
OG0002.41(2.23 to 2.6)
OG0012.19(1.94 to 2.46)
OG0022.51(2.33 to 2.71)
OG003
PT (N=285, N=123, N=281, N=135)
Title
Measurements
OG00047(43 to 52)
OG00145(39 to 53)
OG00245(41 to 50)
OG003
FHA (N=286, N=123, N=281, N=135)
Title
Measurements
OG000102(93 to 112)
OG00197(85 to 112)
OG00299(91 to 109)
OG003
Pertactin (N=286, N=123, N=281, N=135)
Title
Measurements
OG000123(110 to 137)
OG001124(105 to 146)
OG002119(106 to 133)
OG003
Polio Type 1 (N=265, N=112, N=252, N=120)
Title
Measurements
OG000535(462 to 620)
OG001598(477 to 749)
OG002533(458 to 619)
OG003
Polio Type 2 (N=265, N=112, N=252, N=120)
Title
Measurements
OG000353(302 to 411)
OG001366(289 to 463)
OG002318(271 to 372)
OG003
Polio Type 3 (N=265, N=112, N=252, N=120)
Title
Measurements
OG000710(596 to 846)
OG001747(571 to 977)
OG002656(548 to 785)
OG003
Hepatitis B (N=243, N=104, N=237, N=118)
Title
Measurements
OG0002273(2001 to 2583)
OG0012045(1682 to 2485)
OG0021900(1670 to 2162)
OG003
Hib (N=287, N=123, N=283, N=137)
Title
Measurements
OG0007.64(6.63 to 8.8)
OG0016.01(4.84 to 7.47)
OG0027.19(6.23 to 8.29)
OG003
PnC 4 (N=268, N=116, N=256, N=126)
Title
Measurements
OG0002.07(1.88 to 2.27)
OG0012.24(1.94 to 2.58)
OG0021.91(1.74 to 2.1)
OG003
PnC 6B (N=264, N=116, N=255, N=124)
Title
Measurements
OG0002.15(1.85 to 2.49)
OG0012.21(1.76 to 2.77)
OG0022.09(1.8 to 2.44)
OG003
PnC 9V (N=268, N=116, N=256, N=126)
Title
Measurements
OG0001.89(1.71 to 2.1)
OG0012.21(1.89 to 2.6)
OG0021.81(1.63 to 2.02)
OG003
PnC 14 (N=268, N=116, N=256, N=126)
Title
Measurements
OG0007.29(6.42 to 8.29)
OG0018.06(6.63 to 9.78)
OG0027.69(6.75 to 8.77)
OG003
PnC 18C (N=268, N=116, N=256, N=126)
Title
Measurements
OG0001.86(1.68 to 2.07)
OG0012.09(1.78 to 2.44)
OG0021.7(1.53 to 1.89)
OG003
PnC 19F (N=268, N=116, N=254, N=126)
Title
Measurements
OG0002.34(2.1 to 2.6)
OG0012.6(2.2 to 3.06)
OG0022.3(2.06 to 2.57)
OG003
PnC 23F (N=267, N=115, N=256, N=125)
Title
Measurements
OG0001.88(1.64 to 2.16)
OG0012.46(1.99 to 3.03)
OG0022.12(1.84 to 2.44)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
1.16
2-Sided
95
0.96
1.4
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
Tetanus (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
1.1
2-Sided
95
0.96
1.27
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PT (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
1.04
2-Sided
95
0.87
1.25
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
FHA (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
1.05
2-Sided
95
0.89
1.23
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
Pertactin (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.99
2-Sided
95
0.81
1.21
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)
ANOVA
Ratio of GMTs
0.9
2-Sided
95
0.68
1.17
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)
ANOVA
Ratio of GMTs
0.97
2-Sided
95
0.73
1.28
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)
ANOVA
Ratio of GMTs
0.95
95
0.69
1.31
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
1.11
2-Sided
95
0.88
1.4
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
HIb (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
1.27
2-Sided
95
0.98
1.65
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.92
2-Sided
95
0.78
1.09
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.97
2-Sided
95
0.74
1.27
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.86
2-Sided
95
0.71
1.04
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.91
2-Sided
95
0.72
1.14
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.89
2-Sided
95
0.74
1.08
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.9
2-Sided
95
0.74
1.1
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG000
OG001
PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)
ANOVA
Ratio of GMCs
0.77
2-Sided
95
0.6
0.99
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.
OG002
OG003
Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.82
2-Sided
95
0.69
0.99
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
Tetanus (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.95
2-Sided
95
0.83
1.09
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PT (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.93
95
0.78
1.1
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
FHA (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.88
2-Sided
95
0.75
1.03
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
Pertactin (Post-vaccination GMC; group ratio LA3:LA4
ANOVA
Ratio of GMCs
0.8
2-Sided
95
0.66
0.97
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)
ANOVA
Ratio of GMTs
0.78
2-Sided
95
0.6
1.02
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)
ANOVA
Ratio of GMTs
0.83
2-Sided
95
0.63
1.09
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)
ANOVA
Ratio of GMTs
0.81
2-Sided
95
0.59
1.11
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)
ANOVA
Ratio of GMTs
0.95
2-Sided
95
0.76
1.19
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
HIb (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
1.07
2-Sided
95
0.83
1.37
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)
ANOVA
Ratio of GMTs
0.8
2-Sided
95
0.68
0.95
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.87
2-Sided
95
0.67
1.14
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.83
2-Sided
95
0.69
1
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.84
95
0.67
1.05
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.75
2-Sided
95
0.62
0.9
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG003
PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.91
2-Sided
95
0.75
1.1
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG002
OG003
PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)
ANOVA
Ratio of GMCs
0.88
2-Sided
95
0.69
1.12
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.
OG003
LA4 (Infant Vaccines Only)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
OG000
OG001
Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))
ANOVA
Seroconversion Percentage difference
-2
2-Sided
95
-4.8
1.0
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
OG000
OG001
Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))
ANOVA
Seroconversion Percentage difference
-2
2-Sided
95
-4.6
2.3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
OG000
OG001
Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))
ANOVA
Seroconversion Percentage difference
0
2-Sided
95
-3.2
5.1
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
OG000
OG001
Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))
ANOVA
Seroconversion Percentage difference
0
2-Sided
95
-1.5
3.5
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
OG002
OG003
Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))
ANOVA
Seroconversion Percentage difference
0
2-Sided
95
-2
4.7
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
OG002
OG003
Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))
ANOVA
Seroconversion Percentage difference
0
2-Sided
95
-3
4.8
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
OG002
OG003
Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))
ANOVA
Seroconversion Percentage difference
-1
2-Sided
95
-4.4
4.5
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
OG002
OG003
Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))
ANOVA
Seroconversion Percentage difference
0
2-Sided
95
-2.3
2.7
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.
Units
Counts
Participants
OG00084
OG00174
Title
Denominators
Categories
A (84, 74)
Title
Measurements
OG00012(6 to 21)
OG0013(0 to 9)
C (86, 73)
Title
Measurements
OG00053(42 to 64)
OG0018(3 to 17)
W (85, 73)
Title
Measurements
OG00080(70 to 88)
OG0014(1 to 12)
Y (84, 68)
Title
Measurements
OG00074(63 to 83)
OG0011(0 to 8)
Units
Counts
Participants
OG00084
OG00174
Title
Denominators
Categories
A (84, 74)
Title
Measurements
OG00010(4 to 18)
OG0011(0.034 to 7)
C (86, 73)
Title
Measurements
OG00050(39 to 61)
OG0017(2 to 15)
W (85, 73)
Title
Measurements
OG00071(60 to 80)
OG0014(1 to 12)
Y (84, 68)
Title
Measurements
OG00061(49 to 71)
OG0011(0.037 to 8)
Participants
OG00084
OG00174
Title
Denominators
Categories
A (84, 74)
Title
Measurements
OG0002.51(2.14 to 2.96)
OG0012.14(1.8 to 2.54)
C (86, 73)
Title
Measurements
OG0007.72(5.9 to 10)
OG0012.26(1.69 to 3.03)
W (85, 73)
Title
Measurements
OG00014(11 to 18)
OG0012.21(1.69 to 2.9)
Y (84, 68)
Title
Measurements
OG00011(8.76 to 15)
OG0012.14(1.6 to 2.86)
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
OG003
LA4 (Infant Vaccines Only) (12m)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
Units
Counts
Participants
OG000206
OG00178
OG002229
OG003102
Title
Denominators
Categories
A (205, 78, 229, 101)
Title
Measurements
OG00029(23 to 36)
OG0011(0.032 to 7)
OG00218(14 to 24)
OG0031(0.025 to 5)
C (206, 78, 229, 102)
Title
Measurements
OG00062(55 to 68)
OG0014(1 to 11)
OG00232(26 to 38)
OG003
W (198, 70, 218, 98)
Title
Measurements
OG00095(92 to 98)
OG0014(1 to 12)
OG00272(66 to 78)
OG003
Y (195, 71, 212, 95)
Title
Measurements
OG00082(76 to 87)
OG0013(0 to 10)
OG00265(58 to 71)
OG003
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
OG003
LA4 (Infant Vaccines Only) (12m)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
Units
Counts
Participants
OG000206
OG00178
OG002229
OG003102
Title
Denominators
Categories
A (205, 78, 229, 101)
Title
Measurements
OG00025(20 to 32)
OG0010(0 to 5)
OG00215(11 to 20)
OG0030(0 to 4)
C (206, 78, 229, 102)
Title
Measurements
OG00057(50 to 64)
OG0014(1 to 11)
OG00226(20 to 32)
OG003
W (198, 70, 218, 98)
Title
Measurements
OG00085(79 to 90)
OG0014(1 to 12)
OG00263(56 to 69)
OG003
Y (195, 71, 212, 95)
Title
Measurements
OG00072(65 to 78)
OG0013(0 to 10)
OG00252(45 to 59)
OG003
OG003
LA4 (Infant Vaccines Only) (12m)
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
Units
Counts
Participants
OG000206
OG00178
OG002229
OG003102
Title
Denominators
Categories
A (205, 78, 229, 101)
Title
Measurements
OG0004.26(3.55 to 5.11)
OG0012.02(1.7 to 2.4)
OG0022.96(2.63 to 3.33)
OG0032.02(1.74 to 2.35)
C (206, 78, 229, 102)
Title
Measurements
OG00012(9.33 to 15)
OG0012.18(1.73 to 2.74)
OG0024.14(3.54 to 4.84)
OG003
W (198, 70, 218, 98)
Title
Measurements
OG00031(26 to 37)
OG0012.34(1.79 to 3.05)
OG00214(12 to 18)
OG003
Y (195, 71, 212, 95)
Title
Measurements
OG00018(15 to 22)
OG0012.2(1.7 to 2.84)
OG0029.45(7.81 to 11)
OG003
Units
Counts
Participants
OG00084
OG00174
Title
Denominators
Categories
A Pre-vaccination (84, 74)
Title
Measurements
OG00012(6 to 21)
OG0013(0 to 9)
A Post-vaccination (84, 74)
Title
Measurements
OG00094(87 to 98)
OG00178(67 to 87)
C Pre-vaccination (86, 73)
Title
Measurements
OG00053(42 to 64)
OG0018(3 to 17)
C Post-vaccination (86, 73)
Title
Measurements
OG00099(94 to 100)
OG00195(87 to 98)
W Pre-vaccination (85, 73)
Title
Measurements
OG00080(70 to 88)
OG0014(1 to 12)
W Post-vaccination (85, 73)
Title
Measurements
OG000100(6 to 100)
OG00173(61 to 82)
Y Pre-vaccination (84, 68)
Title
Measurements
OG00074(63 to 83)
OG0011(0.037 to 8)
Y Post-vaccination (84, 68)
Title
Measurements
OG000100(96 to 100)
OG00162(49 to 73)
Units
Counts
Participants
OG00084
OG00174
Title
Denominators
Categories
A Pre-vaccination (84, 74)
Title
Measurements
OG00010(4 to 18)
OG0011(0.034 to 7)
A Post-vaccination (84, 74)
Title
Measurements
OG00094(87 to 98)
OG00172(60 to 81)
C Pre-vaccination (86, 73)
Title
Measurements
OG00050(39 to 61)
OG0017(2 to 15)
C Post-vaccination (86, 73)
Title
Measurements
OG00098(92 to 100)
OG00190(81 to 96)
W Pre-vaccination (85, 73)
Title
Measurements
OG00071(60 to 80)
OG0014(1 to 12)
W Post-vaccination (85, 73)
Title
Measurements
OG000100(96 to 100)
OG00158(45 to 69)
Y Pre-vaccination (84, 68)
Title
Measurements
OG00061(49 to 71)
OG0011(0.037 to 8)
Y Post-vaccination (84, 68)
Title
Measurements
OG000100(96 to 100)
OG00156(43 to 68)
Units
Counts
Participants
OG00086
OG00174
Title
Denominators
Categories
A Pre-vaccination (84, 74)
Title
Measurements
OG0005(1 to 12)
OG0011(0.034 to 7)
A Post-vaccination (84, 74)
Title
Measurements
OG00090(82 to 96)
OG00155(43 to 67)
C Pre-vaccination (86, 73)
Title
Measurements
OG00035(25 to 46)
OG0010(0 to 5)
C Post-vaccination (86, 73)
Title
Measurements
OG00095(89 to 99)
OG00178(67 to 87)
W Pre-vaccination (85, 73)
Title
Measurements
OG00048(37 to 59)
OG0013(0 to 10)
W Post-vaccination (85, 73)
Title
Measurements
OG000100(96 to 100)
OG00138(27 to 50)
Y Pre-vaccination (84, 68)
Title
Measurements
OG00045(34 to 56)
OG0011(0.037 to 8)
Y Post-vaccination (84, 68)
Title
Measurements
OG000100(96 to 100)
OG00141(29 to 54)
Units
Counts
Participants
OG00084
OG00174
Title
Denominators
Categories
A Pre-vaccination (84, 74)
Title
Measurements
OG0002.51(2.14 to 2.96)
OG0012.14(1.8 to 2.54)
A Post-vaccination (84, 74)
Title
Measurements
OG00077(55 to 109)
OG00117(12 to 25)
C Pre-vaccination (86, 73)
Title
Measurements
OG0007.72(5.9 to 10)
OG0012.26(1.69 to 3.03)
C Post-vaccination (86, 73)
Title
Measurements
OG000227(155 to 332)
OG00135(23 to 54)
W Pre-vaccination (85, 73)
Title
Measurements
OG00014(11 to 18)
OG0012.21(1.69 to 2.9)
W Post-vaccination (85, 73)
Title
Measurements
OG000416(288 to 602)
OG00111(7.59 to 17)
Y Pre-vaccination (84, 68)
Title
Measurements
OG00011(8.76 to 15)
OG0012.14(1.6 to 2.86)
Y Post-vaccination (84, 68)
Title
Measurements
OG000395(269 to 580)
OG00110(6.72 to 16)
Units
Counts
Participants
OG000103
OG001122
Title
Denominators
Categories
A Pre-vaccination (103, 120)
Title
Measurements
OG00028(20 to 38)
OG00118(12 to 26)
A Post-vaccination (103,120)
Title
Measurements
OG00094(88 to 98)
OG00195(89 to 98)
C Pre-vaccination (102,122)
Title
Measurements
OG00061(51 to 70)
OG00130(22 to 38)
C Post-vaccination (102,122)
Title
Measurements
OG00098(93 to 100)
OG00198(94 to 100)
W Pre-vaccination (98,112)
Title
Measurements
OG00097(91 to 99)
OG00171(61 to 79)
W Post-vaccination (98,112)
Title
Measurements
OG000100(96 to 100)
OG001100(97 to 100)
Y Pre-vaccination (98,109)
Title
Measurements
OG00078(68 to 85)
OG00161(52 to 71)
Y Post-vaccination (98,109)
Title
Measurements
OG00099(94 to 100)
OG00199(95 to 100)
Units
Counts
Participants
OG000103
OG001122
Title
Denominators
Categories
A Pre-vaccination (103, 120)
Title
Measurements
OG00023(16 to 33)
OG00113(8 to 21)
A Post-vaccination (103,120)
Title
Measurements
OG00094(88 to 98)
OG00195(89 to 98)
C Pre-vaccination (102,122)
Title
Measurements
OG00057(47 to 67)
OG00122(15 to 31)
C Post-vaccination (102,122)
Title
Measurements
OG00097(92 to 99)
OG00198(94 to 100)
W Pre-vaccination (98,112)
Title
Measurements
OG00084(75 to 90)
OG00162(52 to 71)
W Post-vaccination (98,112)
Title
Measurements
OG00099(94 to 100)
OG001100(97 to 100)
Y Pre-vaccination (98,109)
Title
Measurements
OG00067(57 to 76)
OG00147(37 to 57)
Y Post-vaccination (98,109)
Title
Measurements
OG00099(94 to 100)
OG00199(95 to 100)
Units
Counts
Participants
OG000103
OG001122
Title
Denominators
Categories
A Pre-vaccination (103, 120)
Title
Measurements
OG00016(9 to 24)
OG0019(5 to 16)
A Post-vaccination (103, 120)
Title
Measurements
OG00093(86 to 97)
OG00194(88 to 98)
C Pre-vaccination (102, 122)
Title
Measurements
OG00047(37 to 57)
OG00118(12 to 26)
C Post-vaccination (102, 122)
Title
Measurements
OG00095(89 to 98)
OG00196(91 to 99)
W Pre-vaccination (98,112)
Title
Measurements
OG00064(54 to 74)
OG00150(40 to 60)
W Post-vaccination (98, 112)
Title
Measurements
OG00099(94 to 100)
OG001100(97 to 100)
Y Pre-vaccination (98,109)
Title
Measurements
OG00053(43 to 63)
OG00132(23 to 42)
Y Post-vaccination (98, 109)
Title
Measurements
OG00099(94 to 100)
OG00198(94 to 100)
Units
Counts
Participants
OG000103
OG001122
Title
Denominators
Categories
A Pre-vaccination (103, 120)
Title
Measurements
OG0003.83(3.3 to 4.45)
OG0012.95(2.57 to 3.39)
A Post-vaccination (103, 120)
Title
Measurements
OG000112(85 to 148)
OG001146(113 to 188)
C Pre-vaccination (102, 122)
Title
Measurements
OG00011(8.91 to 13)
OG0013.83(3.2 to 4.6)
C Post-vaccination (102, 122)
Title
Measurements
OG000279(218 to 358)
OG001283(225 to 355)
W Pre-vaccination (98, 112)
Title
Measurements
OG00028(22 to 34)
OG00113(11 to 16)
W Post-vaccination (98, 112)
Title
Measurements
OG000762(604 to 960)
OG001727(586 to 903)
Y Pre-vaccination (98, 109)
Title
Measurements
OG00016(13 to 20)
OG0018.1(6.58 to 9.96)
Y Post-vaccination (98, 109)
Title
Measurements
OG000550(426 to 710)
OG001590(463 to 751)
OG00087
OG00199
Title
Denominators
Categories
PnC 4 (N=86, N=99)
Title
Measurements
OG0002.9(2.33 to 3.61)
OG0013.24(2.64 to 3.97)
PnC 6B (N=86, N=99)
Title
Measurements
OG0006.82(5.67 to 8.21)
OG0018.58(7.22 to 10)
PnC 9V (N=86, N=99)
Title
Measurements
OG0002.8(2.26 to 3.47)
OG0013.13(2.56 to 3.82)
PnC 14 (N=86, N=99)
Title
Measurements
OG00012(9.74 to 14)
OG00115(12 to 17)
PnC 18C (N=87, N=98)
Title
Measurements
OG0002.76(2.26 to 3.38)
OG0012.71(2.24 to 3.27)
PnC 19F(N=86, N=99)
Title
Measurements
OG0003.63(3 to 4.39)
OG0013.48(2.92 to 4.16)
PnC 23F (N=87, N=99)
Title
Measurements
OG0005.31(4.2 to 6.71)
OG0015.63(4.52 to 7.01)
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
PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
0.9
2-Sided
95
0.67
1.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
OG000
OG001
PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
0.8
2-Sided
95
0.62
1.02
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
OG000
OG001
PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
0.89
2-Sided
95
0.67
1.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
OG000
OG001
PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
0.8
2-Sided
95
0.63
1.03
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
OG000
OG001
PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
1.02
2-Sided
95
0.78
1.34
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
OG000
OG001
PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
1.04
95
0.81
1.34
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
OG000
OG001
PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)
ANOVA
Ratio of GMCs
0.94
2-Sided
95
0.69
1.29
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.
Units
Counts
Participants
OG00087
OG00199
OG00281
Title
Denominators
Categories
PnC 4 (N=86, N=99, N=81)
Title
Measurements
OG00091(82 to 96)
OG00190(82 to 95)
OG00284(74 to 91)
PnC 6B (N=86, N=99, N=80)
Title
Measurements
OG000100(96 to 100)
OG00196(90 to 99)
OG00299(93 to 100)
PnC 9V (N=86, N=99, N=80)
Title
Measurements
OG00087(78 to 93)
OG00191(83 to 96)
OG00286(77 to 93)
PnC 14 (N=86, N=99, N=81)
Title
Measurements
OG00099(94 to 100)
OG001100(96 to 100)
OG002100(96 to 100)
PnC 18C (N=87, N=98, N=81)
Title
Measurements
OG00086(77 to 93)
OG00192(85 to 96)
OG00294(86 to 98)
PnC 19F(N=86, N=99, N=80)
Title
Measurements
OG00097(90 to 99)
OG00193(86 to 97)
OG00299(93 to 100)
PnC 23F (N=87, N=99, N=80)
Title
Measurements
OG00093(86 to 97)
OG00195(89 to 98)
OG00299(93 to 100)
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
PnC 4 (percentage difference (US1A - US1B))
ANOVA
Percentage difference
1
2-Sided
95
-8
10
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
OG000
OG001
PnC 6B (percentage difference (US1A - US1B))
ANOVA
Percentage difference
4
2-Sided
95
0
10
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
OG000
OG001
PnC 9V (percentage difference (US1A - US1B))
ANOVA
Percentage difference
-4
2-Sided
95
-13
5
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
OG000
OG001
PnC 14 (percentage difference (US1A - US1B))
ANOVA
Percentage difference
-1
2-Sided
95
-6
3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
OG000
OG001
PnC 18C (percentage difference (US1A:US1B))
ANOVA
Percentage difference
-6
2-Sided
95
-15
3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
OG000
OG001
PnC 19F (percentage difference (US1A:US1B))
ANOVA
Percentage difference
4
2-Sided
95
-4
11
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
OG000
OG001
PnC 239F (percentage difference (US1A:US1B))
ANOVA
Percentage difference
-2
2-Sided
95
-10
5
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.
Counts
Participants
OG00097
OG00197
Title
Denominators
Categories
PnC 4 (N=97, N=97)
Title
Measurements
OG0003.16(2.63 to 3.8)
OG0014.02(3.34 to 4.83)
PnC 6B (N=96, N=97)
Title
Measurements
OG0004.52(3.42 to 5.97)
OG0015.61(4.25 to 7.4)
PnC 9V (N=97, N=97)
Title
Measurements
OG0002.79(2.34 to 3.31)
OG0013.77(3.17 to 4.48)
PnC 14(N=97, N=97)
Title
Measurements
OG0008.91(7.52 to 11)
OG00114(12 to 16)
PnC 18C (N=97, N=97)
Title
Measurements
OG0002.15(1.79 to 2.58)
OG0012.77(2.31 to 3.32)
PnC 19F (N=97, N=97)
Title
Measurements
OG0003.26(2.62 to 4.05)
OG0014.26(3.43 to 5.29)
PnC 23F (N=97, N=97)
Title
Measurements
OG0004.38(3.51 to 5.48)
OG0015.92(4.74 to 7.4)
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
PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.79
2-Sided
95
0.61
1.02
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
OG000
OG001
PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.81
2-Sided
95
0.54
1.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
OG000
OG001
PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.74
2-Sided
95
0.58
0.94
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
OG000
OG001
PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.65
2-Sided
95
0.51
0.82
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
OG000
OG001
PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.78
2-Sided
95
0.6
1.01
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
OG000
OG001
PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.77
2-Sided
95
0.56
1.04
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
OG000
OG001
PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)
ANOVA
Ratio of GMCs
0.74
2-Sided
95
0.54
1.01
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.
Units
Counts
Participants
OG00097
OG00197
Title
Denominators
Categories
PnC 4 (N=97, N=97)
Title
Measurements
OG00093(86 to 97)
OG00195(88 to 98)
PnC 6B (N=96, N=97)
Title
Measurements
OG00086(78 to 93)
OG00189(81 to 94)
PnC 9V (N=97, N=97)
Title
Measurements
OG00092(84 to 96)
OG00195(88 to 98)
PnC 14 (N=97, N=97)
Title
Measurements
OG00099(94 to 100)
OG001100(96 to 100)
PnC 18C (N=97, N=97)
Title
Measurements
OG00080(71 to 88)
OG00195(88 to 98)
PnC 19F (N=97, N=97)
Title
Measurements
OG00090(82 to 95)
OG00193(86 to 97)
PnC 23F (N=97, N=97)
Title
Measurements
OG00095(88 to 98)
OG00195(88 to 98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
PnC 4 (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
-2
2-Sided
95
-9.6
5.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
OG000
OG001
PnC 6B (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
-2
2-Sided
95
-11.9
7.3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
OG000
OG001
PnC 9V (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
-3
2-Sided
95
-10.9
4.3
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
OG000
OG001
PnC 14 (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
-1
2-Sided
95
-5.6
2.7
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
OG000
OG001
PnC 18C (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
-14
2-Sided
95
-24.1
-5.6
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
OG000
OG001
PnC 19F (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
-3
2-Sided
95
-11.6
5.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
OG000
OG001
PnC 23F (percentage difference (LA1A - LA1B))
ANOVA
Percentage difference
0
2-Sided
95
-7
7
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.
Units
Counts
Participants
OG000118
OG001101
Title
Denominators
Categories
Diphtheria (N=118, N=101)
Title
Measurements
OG0005.4(4.74 to 6.15)
OG0015.16(4.48 to 5.94)
Tetanus (N=118, N=101)
Title
Measurements
OG0006.17(5.29 to 7.2)
OG0016.58(5.57 to 7.77)
PT (N=113, N=99)
Title
Measurements
OG00068(58 to 80)
OG00162(52 to 73)
FHA (N=113, N=99)
Title
Measurements
OG000245(208 to 288)
OG001215(181 to 256)
Pertactin (N=113, N=99)
Title
Measurements
OG000238(198 to 286)
OG001197(161 to 240)
Hib (N=117, N=101)
Title
Measurements
OG00035(28 to 43)
OG00141(32 to 51)
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
Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)
ANOVA
Ratio of GMCs
1.05
2-Sided
95
0.86
1.27
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.
OG000
OG001
Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)
ANOVA
Ratio of GMCs
0.94
2-Sided
95
0.75
1.18
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.
OG000
OG001
PT (Post-vaccination GMC; group ratio LA3A:LA3B)
ANOVA
Ratio of GMCs
1.11
2-Sided
95
0.88
1.4
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.
OG000
OG001
FHA (Post-vaccination GMC; group ratio LA3A:LA3B)
ANOVA
Ratio of GMCs
1.14
2-Sided
95
0.9
1.44
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.
OG000
OG001
Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B
ANOVA
Ratio of GMCs
1.21
2-Sided
95
0.92
1.59
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.
OG000
OG001
Hib (Post-vaccination GMC; group ratio LA3A:LA3B)
ANOVA
Ratio of GMCs
0.86
2-Sided
95
0.63
1.16
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.
Units
Counts
Participants
OG000118
OG001101
Title
Denominators
Categories
Diphtheria (≥1.0 IU/mL) (N=118, N=101)
Title
Measurements
OG00098(94 to 100)
OG00198(93 to 100)
Tetanus (≥1.0 IU/mL) (N=118, N=101)
Title
Measurements
OG00098(94 to 100)
OG00198(93 to 100)
PT (≥4 fold rise) (N=113, N=99)
Title
Measurements
OG00089(82 to 94)
OG00184(75 to 90)
FHA (≥4-fold rise) (N=113, N=99)
Title
Measurements
OG00087(79 to 92)
OG00188(80 to 94)
Pertactin (≥4-fold rise) (N=113, N=99)
Title
Measurements
OG00089(82 to 94)
OG00188(80 to 94)
Hib (≥0.15 μg/mL) (N=117, N=101)
Title
Measurements
OG000100(97 to 100)
OG001100(96 to 100)
Hib (≥1.0 μg/mL) (N=117, N=101)
Title
Measurements
OG000100(97 to 100)
OG00199(95 to 100)
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
Diphtheria (percentage difference (LA3A - LA3B))
ANOVA
Percentage difference
0
95
-4.2
5.4
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%
OG000
OG001
Tetanus (percentage difference (LA3A - LA3B))
ANOVA
Percentage difference
0
2-Sided
95
-4.2
5.4
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%
OG000
OG001
PT (percentage difference (LA3A - LA3B))
ANOVA
Percentage difference
6
95
-3.6
15.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%
OG000
OG001
FHA (percentage difference (LA3A - LA3B))
ANOVA
Percentage difference
-1
2-Sided
95
-10.2
8.2
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%
OG000
OG001
Pertactin (percentage difference (LA3A - LA3B))
ANOVA
Percentage difference
2
2-Sided
95
-7.2
10.6
Yes
Non-Inferiority or Equivalence
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%
To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%