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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00450437
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : September 24, 2010
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Meningococcal Infections
Meningococcal Meningitis
Interventions Biological: MenACWY CRM
Biological: Meningococcal ACWY Conjugate vaccine
Enrollment 3539
Recruitment Details Participants were enrolled at 44 centers in the US.
Pre-assignment Details All subjects enrolled were included in the trial. All enrolled subjects were randomized at a 1:1:1:1 ratio to receive one of the four vaccine groups.
Arm/Group Title Novartis MenACWY Vaccine (11 to 18 Years) Licensed Meningococcal Vaccine (11 to 18 Years) Novartis MenACWY Vaccine (19 to 55 Years) Licensed Meningococcal Vaccine (19 to 55 Years)
Hide Arm/Group Description One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly. One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly. One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly. One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
Period Title: Overall Study
Started 1640 540 1023 336
Completed 1594 524 999 325
Not Completed 46 16 24 11
Reason Not Completed
Withdrawal by Subject             10             2             0             1
Lost to Follow-up             31             12             19             9
Protocol Violation             0             1             0             1
Inappropriate enrollment             4             1             3             0
Administrative reason             0             0             1             0
Unable to Classify             1             0             1             0
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine Total
Hide Arm/Group Description One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly. One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly. Total of all reporting groups
Overall Number of Baseline Participants 2663 876 3539
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2663 participants 876 participants 3539 participants
11 to 18 years 14.2  (2.2) 14.1  (2.2) 14.2  (14.1)
19 to 55 years 39.0  (9.6) 38.7  (9.9) 39  (38.7)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2663 participants 876 participants 3539 participants
Female (11 to 18 years) 769 251 1020
Male (11 to 18 years) 871 289 1160
Female (19 to 55 years) 774 252 1026
Male (19 to 55 years) 249 84 333
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2663 participants 876 participants 3539 participants
Asian (11 to 18 years) 45 17 62
Black (11 to 18 years) 138 45 183
Caucasian (11 to 18 years) 1280 423 1703
Hispanic (11 to 18 years) 126 34 160
Other (11 to 18 years) 51 21 72
Asian (19 to 55 years) 37 8 45
Black (19 to 55 years) 85 34 119
Caucasian (19 to 55 years) 828 261 1089
Hispanic (19 to 55 years) 60 29 89
Other (19 to 55 years) 13 4 17
1.Primary Outcome
Title Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Hide Description The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Time Frame 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Per Protocol (PP) Population
Arm/Group Title Novartis MenACWY Lot 1 Novartis MenACWY Lot 2 Novartis MenACWY Lot 3
Hide Arm/Group Description:
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 359 357 359
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A
29
(23 to 38)
33
(25 to 42)
31
(24 to 40)
Serogroup C (N=499, 493, 491)
77
(58 to 102)
58
(43 to 77)
64
(48 to 86)
Serogroup W (N=340, 341, 343)
87
(70 to 108)
111
(89 to 138)
82
(66 to 102)
Serogroup Y (N=345, 345, 346)
48
(37 to 62)
61
(47 to 79)
53
(41 to 69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.68 to 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.73 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.81 to 1.38
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.9 to 1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
1 to 1.77
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.68 to 1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.63 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.86 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.09 to 1.67
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.61 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.7 to 1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.89 to 1.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Seroresponders, Ages 11 to 18 Years
Hide Description

Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Time Frame 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set was the per protocol (PP) population.
Arm/Group Title Novartis MenACWY Vaccine Licensed Meninogcoccal Vaccine
Hide Arm/Group Description:
One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 1075 359
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Serogroup A
75
(72 to 77)
66
(61 to 71)
Serogroup C (N= 1483, 501)
75
(73 to 77)
73
(69 to 77)
Serogroup W (N= 1024, 288)
75
(72 to 77)
63
(57 to 68)
Serogroup Y (N= 1036, 294)
68
(65 to 71)
41
(35 to 47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meninogcoccal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 8
Confidence Interval (2-Sided) 95%
3 to 14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meninogcoccal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 2
Confidence Interval (2-Sided) 95%
-2 to 7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meninogcoccal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 12
Confidence Interval (2-Sided) 95%
6 to 18
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meninogcoccal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 27
Confidence Interval (2-Sided) 95%
20 to 33
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
Hide Description

Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.

Note: severe adverse events: unable to perform normal daily activity

Time Frame 6 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety set.
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Hide Arm/Group Description:
One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 2649 875
Measure Type: Number
Unit of Measure: Participants
94 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.
Type of Statistical Test Non-Inferiority or Equivalence
Comments MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction [MenACWY minus Menactra] was less than 6%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-1 to 2
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Seroresponders, Ages 19 to 55 Years
Hide Description

Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Time Frame 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set was the per protocol (PP) population.
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Hide Arm/Group Description:
One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 963 321
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Serogroup A
67
(64 to 70)
68
(63 to 73)
Serogroup C (N=961, 318)
67
(64 to 70)
58
(53 to 64)
Serogroup W (N= 484, 292)
50
(46 to 55)
41
(35 to 47)
Serogroup Y (N= 503, 306)
56
(51 to 60)
40
(34 to 46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-7 to 5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 9
Confidence Interval (2-Sided) 95%
3 to 15
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 9
Confidence Interval (2-Sided) 95%
2 to 17
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 16
Confidence Interval (2-Sided) 95%
9 to 23
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Hide Description

The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Time Frame 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis set was the per protocol (PP) population.
Arm/Group Title Novartis MenACWY Lot 1 Novartis MenACWY Lot 2 Novartis MenACWY Lot 3
Hide Arm/Group Description:
One dose of the meningococcal ACWY Lot 1 conjugate vaccine was administered intramuscularly.
One dose of the meningococcal ACWY Lot 2 conjugate vaccine was administered intramuscularly.
One dose of the meningococcal ACWY Lot 3 conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 359 357 359
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Seroresponse in serogroup A
71
(66 to 76)
75
(70 to 79)
77
(73 to 82)
Seroresponse in serogroup C (N= 499, 493, 491)
78
(74 to 82)
73
(69 to 77)
74
(70 to 78)
Seroresponse in serogroup W (N= 340, 341, 343)
74
(69 to 78)
80
(75 to 84)
70
(65 to 75)
Seroresponse in serogroup Y (N= 345, 345, 346)
66
(61 to 71)
72
(67 to 77)
65
(60 to 70)
hSBA Titer ≥ 1:8 in serogroup A
72
(67 to 77)
76
(71 to 80)
78
(74 to 82)
hSBA Titer ≥ 1:8 in serogroup C (N= 499, 493, 491)
86
(82 to 89)
84
(81 to 87)
83
(79 to 86)
hSBA Titer ≥ 1:8 in serogroup W (N= 340, 341, 343)
95
(92 to 97)
97
(95 to 99)
96
(93 to 98)
hSBA Titer ≥ 1:8 in serogroup Y (N= 345, 345, 346)
86
(82 to 89)
89
(85 to 92)
88
(85 to 92)
hSBA Titer ≥ 1:4 in serogroup A
76
(72 to 81)
79
(74 to 83)
81
(77 to 85)
hSBA Titer ≥ 1:4 in serogroup C (N= 499, 493, 491)
89
(86 to 91)
88
(85 to 91)
88
(85 to 91)
hSBA Titer ≥ 1:4 in serogroup W (N= 340, 341, 343)
95
(92 to 97)
97
(95 to 99)
97
(94 to 98)
hSBA Titer ≥ 1:4 in serogroup Y (N= 345, 345, 346
89
(85 to 92)
92
(89 to 95)
93
(90 to 96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-10 to 3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -6
Confidence Interval (2-Sided) 95%
-12 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-9 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 5
Confidence Interval (2-Sided) 95%
0 to 10
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 4
Confidence Interval (2-Sided) 95%
-1 to 10
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-6 to 5
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -6
Confidence Interval (2-Sided) 95%
-13 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 4
Confidence Interval (2-Sided) 95%
-3 to 11
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 10
Confidence Interval (2-Sided) 95%
4 to 17
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -6
Confidence Interval (2-Sided) 95%
-13 to 1
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-6 to 8
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 7
Confidence Interval (2-Sided) 95%
0 to 14
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-10 to 3
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -6
Confidence Interval (2-Sided) 95%
-12 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-9 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 2
Confidence Interval (2-Sided) 95%
-3 to 6
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 3
Confidence Interval (2-Sided) 95%
-2 to 7
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-3 to 6
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -2
Confidence Interval (2-Sided) 95%
-5 to 1
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-4 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-2 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-8 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-8 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 0
Confidence Interval (2-Sided) 95%
-5 to 5
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -2
Confidence Interval (2-Sided) 95%
-9 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -5
Confidence Interval (2-Sided) 95%
-11 to 1
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -2
Confidence Interval (2-Sided) 95%
-8 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-3 to 5
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -2
Confidence Interval (2-Sided) 95%
-5 to 1
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-4 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-2 to 3
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 2
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-8 to 1
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 1, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -4
Confidence Interval (2-Sided) 95%
-9 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Lot 2, Novartis MenACWY Lot 3
Comments Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-5 to 3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Hide Description

Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Time Frame 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses set was performed on the per protocol (PP) population.
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Hide Arm/Group Description:
One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 2038 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Seroresponse in serogroup A
71
(69 to 73)
67
(63 to 71)
Seroresponse in serogroup C (N= 2444, 819)
72
(70 to 74)
67
(64 to 70)
Seroresponse in serogroup W (N= 1508, 580)
67
(64 to 69)
52
(47 to 56)
Seroresponse in serogroup Y (N= 1539, 600)
64
(61 to 66)
41
(37 to 45)
hSBA≥1:8 in serogroup A
72
(70 to 74)
69
(65 to 72)
hSBA≥1:8 in serogroup C (N= 2444, 819)
83
(81 to 84)
79
(76 to 82)
hSBA≥1:8 in serogroup W (N= 1508, 580)
95
(94 to 96)
89
(86 to 91)
hSBA≥1:8 in serogroup Y (N= 1539, 600)
85
(83 to 87)
70
(66 to 73)
hSBA≥1:4 in serogroup A
75
(74 to 77)
73
(69 to 76)
hSBA≥1:4 in serogroup C (N= 2444, 819)
87
(86 to 88)
85
(83 to 88)
hSBA≥1:4 in serogroup W (N= 1508, 580)
96
(95 to 97)
91
(88 to 93)
hSBA≥1:4 in serogroup Y (N= 1539, 600)
90
(88 to 91)
77
(74 to 81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 4
Confidence Interval (2-Sided) 95%
0 to 8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 5
Confidence Interval (2-Sided) 95%
1 to 9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 15
Confidence Interval (2-Sided) 95%
11 to 20
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 23
Confidence Interval (2-Sided) 95%
19 to 28
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 4
Confidence Interval (2-Sided) 95%
0 to 8
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 3
Confidence Interval (2-Sided) 95%
0 to 7
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 6
Confidence Interval (2-Sided) 95%
4 to 9
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 15
Confidence Interval (2-Sided) 95%
12 to 20
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 3
Confidence Interval (2-Sided) 95%
-1 to 7
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-1 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 6
Confidence Interval (2-Sided) 95%
3 to 8
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine group difference
Estimated Value 12
Confidence Interval (2-Sided) 95%
9 to 16
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Hide Description Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
Time Frame 28 days after vaccination
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Hide Analysis Population Description
The analysis set was the per protocol (PP) population.
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Hide Arm/Group Description:
One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 2038 680
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Titers in serogroup A
29
(26 to 32)
22
(19 to 26)
Titers in serogroup C (N= 2444, 819)
55
(49 to 62)
39
(33 to 47)
Titers in serogroup W (N= 1508, 580)
100
(90 to 112)
57
(49 to 66)
Titers in serogroup Y (N= 1539 600)
53
(47 to 60)
21
(18 to 25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments

Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.

The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.12 to 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments

Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.

The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.17 to 1.67
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments

Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.

The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.51 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Novartis MenACWY Vaccine, Licensed Meningococcal Vaccine
Comments

Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.

The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter hSBA GMT ratios
Estimated Value 2.49
Confidence Interval (2-Sided) 95%
2.11 to 2.95
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Hide Description Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).
Time Frame Days 1 to 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety set.
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Hide Arm/Group Description:
One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Overall Number of Participants Analyzed 2649 875
Measure Type: Number
Unit of Measure: Participants
Pain 1105 424
Erythema 414 126
Induration 324 88
Chills 168 50
Nausea 260 65
Malaise 279 99
Myalgia 452 149
Arthralgia 197 54
Headache 731 237
Rash 69 20
Fever ≥38°C 32 6
Any Other Reaction 555 183
Analgesic/Antipyretic Medication Used 533 178
Stayed Home 69 17
Time Frame Serious adverse events were collected from study day 1 to 180.
Adverse Event Reporting Description A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
 
Arm/Group Title Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Hide Arm/Group Description One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age. One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
All-Cause Mortality
Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/2649 (0.87%)      5/875 (0.57%)    
Congenital, familial and genetic disorders     
Vitello-Intestinal Duct Remnant *  1/2649 (0.04%)  1 0/875 (0.00%)  0
General disorders     
Chest Pain *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Infections and infestations     
Appendicitis *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Meningitis Viral *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Pneumonia *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Staphylococcal Infection *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Tonsillitis *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Burns Second Degree *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Clavicle Fracture *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Dislocation of Sternum *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Fall *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Intentional Overdose *  1/2649 (0.04%)  2 0/875 (0.00%)  0
Ligament Rupture *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Overdose *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Road Traffic Accident *  3/2649 (0.11%)  3 0/875 (0.00%)  0
Spinal Compression Fracture *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Toxicity to Various Agents *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Craniocerebral Injury *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Epishysiolysis *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Intervertebral Disc Protrusion *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Nervous system disorders     
Dystonia *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Epilepsy *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Hypoaesthesia *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Myoclonic Epilepsy *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Simple Partial Seizures *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Syncope *  0/2649 (0.00%)  0 1/875 (0.11%)  1
Psychiatric disorders     
Depression Suicidal *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Suicide Attempt *  2/2649 (0.08%)  2 0/875 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Respiratory Failure *  1/2649 (0.04%)  1 0/875 (0.00%)  0
Vascular disorders     
Circulatory Collapse *  0/2649 (0.00%)  0 1/875 (0.11%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Novartis MenACWY Vaccine Licensed Meningococcal Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1613/2649 (60.89%)      572/875 (65.37%)    
Gastrointestinal disorders     
Nausea   265/2649 (10.00%)  66/875 (7.54%) 
General disorders     
Injection site pain   1106/2649 (41.75%)  424/875 (48.46%) 
Injection site erythema   414/2649 (15.63%)  126/875 (14.40%) 
Injection site induration   324/2649 (12.23%)  88/875 (10.06%) 
Chills   169/2649 (6.38%)  50/875 (5.71%) 
Malaise   280/2649 (10.57%)  100/875 (11.43%) 
Musculoskeletal and connective tissue disorders     
Myalgia   453/2649 (17.10%)  150/875 (17.14%) 
Arthralgia   211/2649 (7.97%)  59/875 (6.74%) 
Nervous system disorders     
Headache   740/2649 (27.94%)  240/875 (27.43%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@Novartis.com
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Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00450437     History of Changes
Other Study ID Numbers: V59P13
First Submitted: March 21, 2007
First Posted: March 22, 2007
Results First Submitted: March 19, 2010
Results First Posted: September 24, 2010
Last Update Posted: January 28, 2015