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

This study has been completed.

Sponsor:

Novartis Vaccines

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00450437

First received: March 21, 2007

Last updated: January 15, 2015

Last verified: January 2015

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Results First Received: March 19, 2010

Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention |

Conditions: |
Meningococcal Infections Meningococcal Meningitis |

Interventions: |
Biological: MenACWY CRM Biological: Meningococcal ACWY Conjugate vaccine |

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Participants were enrolled at 44 centers in the US. |

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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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. |

Reporting Groups

Description | |
---|---|

Novartis MenACWY Vaccine (11 to 18 Years) | One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly. |

Licensed Meningococcal Vaccine (11 to 18 Years) | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly. |

Novartis MenACWY Vaccine (19 to 55 Years) | One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly. |

Licensed Meningococcal Vaccine (19 to 55 Years) | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly. |

Participant Flow: Overall Study

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) | |
---|---|---|---|---|

STARTED | 1640 | 540 | 1023 | 336 |

COMPLETED | 1594 | 524 | 999 | 325 |

NOT COMPLETED | 46 | 16 | 24 | 11 |

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 |

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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No text entered. |

Reporting Groups

Description | |
---|---|

Novartis MenACWY Vaccine | One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly. |

Licensed Meningococcal Vaccine | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly. |

Total | Total of all reporting groups |

Baseline Measures

Novartis MenACWY Vaccine | Licensed Meningococcal Vaccine | Total | |
---|---|---|---|

Number of Participants
[units: participants] |
2663 | 876 | 3539 |

Age
[units: years] Mean (Standard Deviation) |
|||

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) |

Gender, Customized
[units: 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
[units: 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 |

Outcome Measures

1. Primary: | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years [ Time Frame: 28 days after vaccination ] |

Hide Outcome Measure 1

Population Description

Reporting Groups

Measured Values

Statistical Analysis 1 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 2 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 3 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 4 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 5 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 6 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 7 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 8 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 9 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 10 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 11 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Statistical Analysis 12 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Measure Type | Primary |
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Measure Title | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years |

Measure 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 |

Safety Issue | No |

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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The analysis was performed on the Per Protocol (PP) Population |

Reporting Groups

Description | |
---|---|

Novartis MenACWY Lot 1 | One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly. |

Novartis MenACWY Lot 2 | One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly. |

Novartis MenACWY Lot 3 | One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly. |

Measured Values

Novartis MenACWY Lot 1 | Novartis MenACWY Lot 2 | Novartis MenACWY Lot 3 | |
---|---|---|---|

Number of Participants Analyzed
[units: participants] |
359 | 357 | 359 |

Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
[units: Titers] Geometric Mean (95% Confidence Interval) |
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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) |

Statistical Analysis 1 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 2 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
0.89 |

95% Confidence Interval | 0.68 to 1.16 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 2 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
0.95 |

95% Confidence Interval | 0.73 to 1.23 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 3 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 2 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
1.06 |

95% Confidence Interval | 0.81 to 1.38 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 4 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
1.2 |

95% Confidence Interval | 0.9 to 1.6 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 5 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 2 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
1.33 |

95% Confidence Interval | 1 to 1.77 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 6 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 2 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
0.9 |

95% Confidence Interval | 0.68 to 1.2 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 7 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 2 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
0.79 |

95% Confidence Interval | 0.63 to 0.97 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 8 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
1.06 |

95% Confidence Interval | 0.86 to 1.13 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 9 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 2 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
1.35 |

95% Confidence Interval | 1.09 to 1.67 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 10 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 2 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
0.79 |

95% Confidence Interval | 0.61 to 1.02 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 11 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 1 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
0.91 |

95% Confidence Interval | 0.7 to 1.18 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

Statistical Analysis 12 for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Groups ^{[1]} |
Novartis MenACWY Lot 2 vs. Novartis MenACWY Lot 3 |
---|---|

Non-Inferiority/Equivalence Test ^{[2]} |
Yes |

Method ^{[3]} |
ANOVA |

hSBA GMT ratios ^{[4]} |
1.16 |

95% Confidence Interval | 0.89 to 1.5 |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

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). | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | Other relevant estimation information: |

No text entered. |

2. Primary: | Percentage of Seroresponders, Ages 11 to 18 Years [ Time Frame: 28 days after vaccination ] |

3. Primary: | Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years [ Time Frame: 6 days after vaccination ] |

4. Primary: | Percentage of Seroresponders, Ages 19 to 55 Years [ Time Frame: 28 days after vaccination ] |

5. Secondary: | 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 [ Time Frame: 28 days after vaccination ] |

6. Secondary: | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years [ Time Frame: 28 days after vaccination ] |

7. Secondary: | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years [ Time Frame: 28 days after vaccination ] |

8. Secondary: | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years [ Time Frame: Days 1 to 7 ] |

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |