Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningococcal, meningitis, vaccine, adolescents, adults
Brief summary
This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
Interventions
BIOLOGICALMenACWY CRM
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
BIOLOGICALMeningococcal ACWY Conjugate vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent
Exclusion criteria
* Subjects with a previous or suspected disease caused by N. meningitidis * previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * previous or suspected disease caused by N. meningitidis * Any serious acute, chronic or progressive disease * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Seroresponders, Ages 19 to 55 Years | 28 days after vaccination | 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. |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | 28 days after vaccination | 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) |
| Percentage of Seroresponders, Ages 11 to 18 Years | 28 days after vaccination | 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. |
| Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | 6 days after vaccination | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 28 days after vaccination | 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. |
| Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | 28 days after vaccination | 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. |
| Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | 28 days after vaccination | 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). |
| Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Days 1 to 7 | 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). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Novartis MenACWY Vaccine One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly. | 2,663 |
| Licensed Meningococcal Vaccine One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly. | 876 |
| Total | 3,539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative reason | 0 | 0 | 1 | 0 |
| Overall Study | Inappropriate enrollment | 4 | 1 | 3 | 0 |
| Overall Study | Lost to Follow-up | 31 | 12 | 19 | 9 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 |
| Overall Study | Unable to Classify | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Novartis MenACWY Vaccine | Licensed Meningococcal Vaccine | Total |
|---|---|---|---|
| Age, Continuous 11 to 18 years | 14.2 years STANDARD_DEVIATION 2.2 | 14.1 years STANDARD_DEVIATION 2.2 | 14.2 years STANDARD_DEVIATION 14.1 |
| Age, Continuous 19 to 55 years | 39.0 years STANDARD_DEVIATION 9.6 | 38.7 years STANDARD_DEVIATION 9.9 | 39 years STANDARD_DEVIATION 38.7 |
| Race/Ethnicity, Customized Asian (11 to 18 years) | 45 participants | 17 participants | 62 participants |
| Race/Ethnicity, Customized Asian (19 to 55 years) | 37 participants | 8 participants | 45 participants |
| Race/Ethnicity, Customized Black (11 to 18 years) | 138 participants | 45 participants | 183 participants |
| Race/Ethnicity, Customized Black (19 to 55 years) | 85 participants | 34 participants | 119 participants |
| Race/Ethnicity, Customized Caucasian (11 to 18 years) | 1280 participants | 423 participants | 1703 participants |
| Race/Ethnicity, Customized Caucasian (19 to 55 years) | 828 participants | 261 participants | 1089 participants |
| Race/Ethnicity, Customized Hispanic (11 to 18 years) | 126 participants | 34 participants | 160 participants |
| Race/Ethnicity, Customized Hispanic (19 to 55 years) | 60 participants | 29 participants | 89 participants |
| Race/Ethnicity, Customized Other (11 to 18 years) | 51 participants | 21 participants | 72 participants |
| Race/Ethnicity, Customized Other (19 to 55 years) | 13 participants | 4 participants | 17 participants |
| Sex/Gender, Customized Female (11 to 18 years) | 769 participants | 251 participants | 1020 participants |
| Sex/Gender, Customized Female (19 to 55 years) | 774 participants | 252 participants | 1026 participants |
| Sex/Gender, Customized Male (11 to 18 years) | 871 participants | 289 participants | 1160 participants |
| Sex/Gender, Customized Male (19 to 55 years) | 249 participants | 84 participants | 333 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,613 / 2,649 | 572 / 875 |
| serious Total, serious adverse events | 23 / 2,649 | 5 / 875 |
Outcome results
Primary
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
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
Population: The analysis was performed on the Per Protocol (PP) Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup A | 29 Titers |
| Novartis MenACWY Lot 1 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup C (N=499, 493, 491) | 77 Titers |
| Novartis MenACWY Lot 1 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup W (N=340, 341, 343) | 87 Titers |
| Novartis MenACWY Lot 1 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup Y (N=345, 345, 346) | 48 Titers |
| Novartis MenACWY Lot 2 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup Y (N=345, 345, 346) | 61 Titers |
| Novartis MenACWY Lot 2 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup A | 33 Titers |
| Novartis MenACWY Lot 2 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup W (N=340, 341, 343) | 111 Titers |
| Novartis MenACWY Lot 2 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup C (N=499, 493, 491) | 58 Titers |
| Novartis MenACWY Lot 3 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup Y (N=345, 345, 346) | 53 Titers |
| Novartis MenACWY Lot 3 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup C (N=499, 493, 491) | 64 Titers |
| Novartis MenACWY Lot 3 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup W (N=340, 341, 343) | 82 Titers |
| Novartis MenACWY Lot 3 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Serogroup A | 31 Titers |
Comparison: 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).95% CI: [0.68, 1.16]ANOVA
Comparison: 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).95% CI: [0.73, 1.23]ANOVA
Comparison: 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).95% CI: [0.81, 1.38]ANOVA
Comparison: 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).95% CI: [0.9, 1.6]ANOVA
Comparison: 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).95% CI: [1, 1.77]ANOVA
Comparison: 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).95% CI: [0.68, 1.2]ANOVA
Comparison: 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).95% CI: [0.63, 0.97]ANOVA
Comparison: 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).95% CI: [0.86, 1.13]ANOVA
Comparison: 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).95% CI: [1.09, 1.67]ANOVA
Comparison: 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).95% CI: [0.61, 1.02]ANOVA
Comparison: 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).95% CI: [0.7, 1.18]ANOVA
Comparison: 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).95% CI: [0.89, 1.5]ANOVA
Primary
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
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
Population: The analysis was performed on the safety set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novartis MenACWY Lot 1 | Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | 94 Participants |
| Novartis MenACWY Lot 2 | Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | 24 Participants |
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.95% CI: [-1, 2]ANOVA
Primary
Percentage of Seroresponders, Ages 11 to 18 Years
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
Population: The analysis set was the per protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup A | 75 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup W (N= 1024, 288) | 75 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup C (N= 1483, 501) | 75 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup Y (N= 1036, 294) | 68 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup Y (N= 1036, 294) | 41 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup A | 66 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup C (N= 1483, 501) | 73 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 11 to 18 Years | Serogroup W (N= 1024, 288) | 63 Percentage of participants |
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.95% CI: [3, 14]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.95% CI: [-2, 7]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.95% CI: [6, 18]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.95% CI: [20, 33]ANOVA
Primary
Percentage of Seroresponders, Ages 19 to 55 Years
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
Population: The analysis set was the per protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup A | 67 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup C (N=961, 318) | 67 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup W (N= 484, 292) | 50 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup Y (N= 503, 306) | 56 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup Y (N= 503, 306) | 40 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup A | 68 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup W (N= 484, 292) | 41 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Seroresponders, Ages 19 to 55 Years | Serogroup C (N=961, 318) | 58 Percentage of participants |
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.95% CI: [3, 15]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.95% CI: [2, 17]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.95% CI: [-7, 5]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.95% CI: [9, 23]ANOVA
Secondary
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
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
Population: The analysis set was the per protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup C (N= 2444, 819) | 55 Titers |
| Novartis MenACWY Lot 1 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup A | 29 Titers |
| Novartis MenACWY Lot 1 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup W (N= 1508, 580) | 100 Titers |
| Novartis MenACWY Lot 1 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup Y (N= 1539 600) | 53 Titers |
| Novartis MenACWY Lot 2 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup Y (N= 1539 600) | 21 Titers |
| Novartis MenACWY Lot 2 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup A | 22 Titers |
| Novartis MenACWY Lot 2 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup C (N= 2444, 819) | 39 Titers |
| Novartis MenACWY Lot 2 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Titers in serogroup W (N= 1508, 580) | 57 Titers |
Comparison: 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 0.5.95% CI: [1.12, 1.56]ANOVA
Comparison: 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 0.5.95% CI: [1.17, 1.67]ANOVA
Comparison: 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 0.5.95% CI: [1.51, 2.05]ANOVA
Comparison: 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 0.5.95% CI: [2.11, 2.95]ANOVA
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
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
Population: The Analysis set was the per protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | 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 | Seroresponse in serogroup C (N= 499, 493, 491) | 78 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:4 in serogroup A | 76 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:4 in serogroup C (N= 499, 493, 491) | 89 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | Seroresponse in serogroup W (N= 340, 341, 343) | 74 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:4 in serogroup Y (N= 345, 345, 346 | 89 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:4 in serogroup W (N= 340, 341, 343) | 95 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | Seroresponse in serogroup Y (N= 345, 345, 346) | 66 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | Seroresponse in serogroup A | 71 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:8 in serogroup A | 72 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:8 in serogroup C (N= 499, 493, 491) | 86 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:8 in serogroup W (N= 340, 341, 343) | 95 Percentage of Participants |
| Novartis MenACWY Lot 1 | 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 | hSBA Titer ≥ 1:8 in serogroup Y (N= 345, 345, 346) | 86 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:8 in serogroup W (N= 340, 341, 343) | 97 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | Seroresponse in serogroup Y (N= 345, 345, 346) | 72 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:4 in serogroup A | 79 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | Seroresponse in serogroup C (N= 499, 493, 491) | 73 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:8 in serogroup C (N= 499, 493, 491) | 84 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:4 in serogroup C (N= 499, 493, 491) | 88 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:8 in serogroup Y (N= 345, 345, 346) | 89 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:4 in serogroup W (N= 340, 341, 343) | 97 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | Seroresponse in serogroup W (N= 340, 341, 343) | 80 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:8 in serogroup A | 76 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | hSBA Titer ≥ 1:4 in serogroup Y (N= 345, 345, 346 | 92 Percentage of Participants |
| Novartis MenACWY Lot 2 | 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 | Seroresponse in serogroup A | 75 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:4 in serogroup Y (N= 345, 345, 346 | 93 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:8 in serogroup Y (N= 345, 345, 346) | 88 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | Seroresponse in serogroup A | 77 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | Seroresponse in serogroup W (N= 340, 341, 343) | 70 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | Seroresponse in serogroup Y (N= 345, 345, 346) | 65 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:8 in serogroup A | 78 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:8 in serogroup C (N= 499, 493, 491) | 83 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:8 in serogroup W (N= 340, 341, 343) | 96 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:4 in serogroup A | 81 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:4 in serogroup C (N= 499, 493, 491) | 88 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | hSBA Titer ≥ 1:4 in serogroup W (N= 340, 341, 343) | 97 Percentage of Participants |
| Novartis MenACWY Lot 3 | 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 | Seroresponse in serogroup C (N= 499, 493, 491) | 74 Percentage of Participants |
Comparison: 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%).95% CI: [-10, 3]ANOVA
Comparison: 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%).95% CI: [-12, 0]ANOVA
Comparison: 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%).95% CI: [-9, 4]ANOVA
Comparison: 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%).95% CI: [0, 10]ANOVA
Comparison: 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%).95% CI: [-1, 10]ANOVA
Comparison: 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%).95% CI: [-6, 5]ANOVA
Comparison: 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%).95% CI: [-13, 0]ANOVA
Comparison: 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%).95% CI: [-3, 11]ANOVA
Comparison: 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%).95% CI: [4, 17]ANOVA
Comparison: 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%).95% CI: [-13, 1]ANOVA
Comparison: 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%).95% CI: [-6, 8]ANOVA
Comparison: 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%).95% CI: [0, 14]ANOVA
Comparison: 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%).95% CI: [-10, 3]ANOVA
Comparison: 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%).95% CI: [-12, 0]ANOVA
Comparison: 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%).95% CI: [-9, 4]ANOVA
Comparison: 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%).95% CI: [-3, 6]ANOVA
Comparison: 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%).95% CI: [-2, 7]ANOVA
Comparison: 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%).95% CI: [-3, 6]ANOVA
Comparison: 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%).95% CI: [-5, 1]ANOVA
Comparison: 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%).95% CI: [-4, 2]ANOVA
Comparison: 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%).95% CI: [-2, 4]ANOVA
Comparison: 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%).95% CI: [-8, 2]ANOVA
Comparison: 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%).95% CI: [-8, 2]ANOVA
Comparison: 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%).95% CI: [-5, 5]ANOVA
Comparison: 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%).95% CI: [-9, 4]ANOVA
Comparison: 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%).95% CI: [-11, 1]ANOVA
Comparison: 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%).95% CI: [-8, 4]ANOVA
Comparison: 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%)95% CI: [-3, 5]ANOVA
Comparison: 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%).95% CI: [-4, 4]ANOVA
Comparison: 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%).95% CI: [-4, 4]ANOVA
Comparison: 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%).95% CI: [-5, 1]ANOVA
Comparison: 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%).95% CI: [-4, 2]ANOVA
Comparison: 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%).95% CI: [-2, 3]ANOVA
Comparison: 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%).95% CI: [-8, 1]ANOVA
Comparison: 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%).95% CI: [-9, 0]ANOVA
Comparison: 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%).95% CI: [-5, 3]ANOVA
Secondary
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
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
Population: The analysis was performed on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Pain | 1105 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Rash | 69 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Erythema | 414 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Induration | 324 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Chills | 168 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Nausea | 260 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Malaise | 279 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Myalgia | 452 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Arthralgia | 197 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Headache | 731 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Fever ≥38°C | 32 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Any Other Reaction | 555 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Analgesic/Antipyretic Medication Used | 533 Participants |
| Novartis MenACWY Lot 1 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Stayed Home | 69 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Any Other Reaction | 183 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Analgesic/Antipyretic Medication Used | 178 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Myalgia | 149 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Pain | 424 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Fever ≥38°C | 6 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Erythema | 126 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Arthralgia | 54 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Induration | 88 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Stayed Home | 17 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Chills | 50 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Headache | 237 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Nausea | 65 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Rash | 20 Participants |
| Novartis MenACWY Lot 2 | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Malaise | 99 Participants |
Secondary
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
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
Population: The analyses set was performed on the per protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup A | 75 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup A | 72 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup C (N= 2444, 819) | 72 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup C (N= 2444, 819) | 83 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup C (N= 2444, 819) | 87 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup W (N= 1508, 580) | 95 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup W (N= 1508, 580) | 67 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup A | 71 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup W (N= 1508, 580) | 96 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup Y (N= 1539, 600) | 64 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup Y (N= 1539, 600) | 90 Percentage of participants |
| Novartis MenACWY Lot 1 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup Y (N= 1539, 600) | 85 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup Y (N= 1539, 600) | 77 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup Y (N= 1539, 600) | 70 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup A | 73 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup A | 67 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup C (N= 2444, 819) | 67 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup W (N= 1508, 580) | 52 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Seroresponse in serogroup Y (N= 1539, 600) | 41 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup A | 69 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup C (N= 2444, 819) | 79 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:8 in serogroup W (N= 1508, 580) | 89 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup C (N= 2444, 819) | 85 Percentage of participants |
| Novartis MenACWY Lot 2 | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | hSBA≥1:4 in serogroup W (N= 1508, 580) | 91 Percentage of participants |
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.95% CI: [0, 8]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.95% CI: [1, 9]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.95% CI: [11, 20]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.95% CI: [19, 28]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.95% CI: [0, 8]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.95% CI: [0, 7]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.95% CI: [4, 9]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.95% CI: [12, 20]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.95% CI: [-1, 7]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.95% CI: [-1, 4]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.95% CI: [3, 8]ANOVA
Comparison: Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.95% CI: [9, 16]ANOVA