Meningococcal Meningitis, Meningococcal Infections
Conditions
Keywords
Meningococcal, meningitis, vaccine, adolescents, adults
Brief summary
This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.
Interventions
BIOLOGICALMeningococcal ACWY Polysaccharide Vaccine
One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
BIOLOGICALMenACWY CRM (19 to 55 years)
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
BIOLOGICALMeningococcal ACWY Conjugate Vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
BIOLOGICALNovartis MenACWY Vaccine (56 to 65 Years)
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent * individuals who are available for all visits and telephone calls scheduled for the study; * individuals who are in good health
Exclusion criteria
* individuals with a previous or suspected disease caused by N. meningitidis * individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * individuals with previous or suspected disease caused by N. meningitidis * individuals with any serious acute, chronic or progressive disease * individuals who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years | Days 1 to 7 | Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | 1 month postvaccination | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years). Seroresponse: 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. |
| Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | 1 month postvaccination | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age. |
| Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | 1 month postvaccination | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years). Seroresponse: 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 Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Days 1 to 7 | Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years). |
| Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Days 1 to 7 | Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years). |
| Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | 1 month postvaccination | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age. |
Countries
Argentina, Colombia
Participant flow
Recruitment details
Subjects were enrolled at 3 centers in Argentina and Colombia.
Pre-assignment details
All subjects enrolled were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Novartis MenACWY Vaccine (19 to 55 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution. | 1,606 |
| Novartis MenACWY Vaccine (56 to 65 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution. | 217 |
| Licensed Conjugate Vaccine (19 to 55 Years) One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years). | 899 |
| Licensed Polysaccharide Vaccine (56 to 65 Years) One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution. | 109 |
| Total | 2,831 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Inappropriate enrollment | 4 | 0 | 7 | 0 |
| Overall Study | Lost to Follow-up | 20 | 1 | 7 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Novartis MenACWY Vaccine (19 to 55 Years) | Total | Licensed Polysaccharide Vaccine (56 to 65 Years) | Licensed Conjugate Vaccine (19 to 55 Years) | Novartis MenACWY Vaccine (56 to 65 Years) |
|---|---|---|---|---|---|
| Age, Continuous | 34.6 Years STANDARD_DEVIATION 10.1 | 37.6 Years STANDARD_DEVIATION 12.6 | 60.1 Years STANDARD_DEVIATION 2.6 | 34.8 Years STANDARD_DEVIATION 10.4 | 60.1 Years STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized Asian | 1 Subjects | 3 Subjects | 0 Subjects | 1 Subjects | 1 Subjects |
| Race/Ethnicity, Customized Black | 135 Subjects | 270 Subjects | 8 Subjects | 109 Subjects | 18 Subjects |
| Race/Ethnicity, Customized Caucasian | 249 Subjects | 437 Subjects | 23 Subjects | 127 Subjects | 38 Subjects |
| Race/Ethnicity, Customized Hispanic | 1217 Subjects | 2110 Subjects | 77 Subjects | 658 Subjects | 158 Subjects |
| Race/Ethnicity, Customized Not Available | 0 Subjects | 1 Subjects | 0 Subjects | 1 Subjects | 0 Subjects |
| Race/Ethnicity, Customized Other | 4 Subjects | 10 Subjects | 1 Subjects | 3 Subjects | 2 Subjects |
| Sex: Female, Male Female | 1092 Participants | 1961 Participants | 79 Participants | 627 Participants | 163 Participants |
| Sex: Female, Male Male | 514 Participants | 870 Participants | 30 Participants | 272 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 955 / 1,588 | 124 / 216 | 561 / 882 | 62 / 109 |
| serious Total, serious adverse events | 11 / 1,588 | 1 / 216 | 8 / 882 | 1 / 109 |
Outcome results
Primary
Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.
Time frame: Days 1 to 7
Population: The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novartis MenACWY Vaccine | Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years | 95 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years | 46 Subjects |
Secondary
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years
Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).
Time frame: Days 1 to 7
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Any local reaction | 729 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Pain | 632 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Erythema | 207 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Induration | 179 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Any systemic reaction | 616 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Chills | 124 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Nausea | 112 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Malaise | 309 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Myalgia | 197 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Arthralgia | 118 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Headache | 421 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Rash | 53 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Fever ≥38°C (N= 1587, 882) | 56 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Any Other Reaction | 280 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Analgesic/Antipyretic Med. Used (N=1588, 881) | 250 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Stayed Home (N= 1585, 880) | 75 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Stayed Home (N= 1585, 880) | 46 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Any local reaction | 439 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Myalgia | 131 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Pain | 392 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Fever ≥38°C (N= 1587, 882) | 31 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Erythema | 105 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Arthralgia | 76 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Induration | 115 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Analgesic/Antipyretic Med. Used (N=1588, 881) | 148 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Any systemic reaction | 375 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Headache | 254 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Chills | 70 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Any Other Reaction | 162 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Nausea | 77 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Rash | 22 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Malaise | 186 Subjects |
Secondary
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years
Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).
Time frame: Days 1 to 7
Population: The analysis was done on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Any local reaction | 92 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Pain | 69 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Erythema | 41 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Induration | 39 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Any systemic reaction | 84 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Chills | 26 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Nausea | 20 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Malaise | 50 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Myalgia | 39 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Arthralgia | 25 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Headache | 52 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Rash | 10 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Fever ≥38°C | 6 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Any other reaction | 29 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Analgesic/Antipyretic Med. Used | 25 Subjects |
| Novartis MenACWY Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Stayed Home (N= 214, 108) | 14 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Stayed Home (N= 214, 108) | 6 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Any local reaction | 44 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Myalgia | 11 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Pain | 34 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Fever ≥38°C | 3 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Erythema | 13 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Arthralgia | 11 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Induration | 17 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Analgesic/Antipyretic Med. Used | 14 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Any systemic reaction | 44 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Headache | 30 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Chills | 6 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Any other reaction | 15 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Nausea | 8 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Rash | 2 Subjects |
| Licensed Conjugate Vaccine | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Malaise | 20 Subjects |
Secondary
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population
Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years). Seroresponse: 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: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup W (N= 178, 180) | 98 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup W (N= 178, 180) | 66 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup Y (N= 181, 182) | 88 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup C (N= 180, 183) | 88 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup A | 78 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup Y (N= 181, 182) | 80 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup C (N= 180, 183) | 83 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup A | 81 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup C (N= 180, 183) | 81 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup C (N= 180, 183) | 92 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup W (N= 178, 180) | 93 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup A | 77 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup A | 80 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | hSBA ≥1:8 in serogroup Y (N= 181, 182) | 76 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup W (N= 178, 180) | 53 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Seroresponders in serogroup Y (N= 181, 182) | 58 Percentage of subjects |
Secondary
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population
Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years). Seroresponse: 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: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup A | 86 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup C (N= 84, 41) | 83 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup W (N= 82, 39) | 61 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup Y (N= 84, 41) | 77 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup A | 87 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup C (N= 84, 41) | 90 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup W (N= 82, 39) | 94 Percentage of subjects |
| Novartis MenACWY Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup Y (N= 84, 41) | 88 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup Y (N= 84, 41) | 68 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup A | 61 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup A | 63 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup C (N= 84, 41) | 73 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup W (N= 82, 39) | 95 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup W (N= 82, 39) | 54 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | hSBA ≥1:8 in serogroup C (N= 84, 41) | 83 Percentage of subjects |
| Licensed Conjugate Vaccine | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Seroresponders in serogroup Y (N= 84, 41) | 54 Percentage of subjects |
Secondary
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population
Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup A | 77 Titers |
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup C (N=180, 183) | 114 Titers |
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup W (N=178, 180) | 159 Titers |
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup Y (N=181, 182) | 95 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup Y (N=181, 182) | 40 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup A | 52 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup W (N=178, 180) | 112 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Serogroup C (N=180, 183) | 88 Titers |
Secondary
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population
Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup A | 111 Titers |
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup C (N=84, 41) | 196 Titers |
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup W (N=82, 39) | 164 Titers |
| Novartis MenACWY Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup Y (N=84, 41) | 121 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup Y (N=84, 41) | 28 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup A | 21 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup W (N=82, 39) | 132 Titers |
| Licensed Conjugate Vaccine | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Serogroup C (N=84, 41) | 86 Titers |