Prevention of Meningococcal Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
Interventions
BIOLOGICALMenACWY polysaccharide vaccine
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Inclusion criteria
* Healthy adolescents between and including 11-17 years of age, who provide written informed consent
Exclusion criteria
* Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | 1 month after vaccination | Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | 1 month after vaccination | Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | 12 months after vaccination | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. |
| hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | 12 months after vaccination | Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. |
| Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Day 1 to Day 7 | Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at Seattle, Washington; Pittsburgh, Pennsylvania; Rochester, Minnesota.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM(Ad+) Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | 164 |
| MenACWY-CRM(Ad-) Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | 151 |
| MenACWY-PS - Stage 1 Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme). | 170 |
| MenACWY-PS -Stage 2 Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme). | 39 |
| Total | 524 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 5 |
| Overall Study | Unable to classify | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS - Stage 1 | MenACWY-PS -Stage 2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 14.3 years STANDARD_DEVIATION 1.9 | 14.1 years STANDARD_DEVIATION 1.8 | 14.2 years STANDARD_DEVIATION 1.8 | 14.2 years STANDARD_DEVIATION 2 | 14.2 years STANDARD_DEVIATION 1.8 |
| Sex: Female, Male Female | 66 Participants | 62 Participants | 70 Participants | 11 Participants | 209 Participants |
| Sex: Female, Male Male | 98 Participants | 89 Participants | 100 Participants | 28 Participants | 315 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 | 123 / 164 | 126 / 151 | 128 / 170 | 31 / 39 |
| serious Total, serious adverse events | 4 / 164 | 2 / 151 | 5 / 170 | 2 / 39 |
Outcome results
Primary
Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y
Time frame: 1 month after vaccination
Population: Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad+) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenA (N=158,148,179) | 87 Percentages Of Subjects |
| MenACWY-CRM(Ad+) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenC (N=161,148,177) | 93 Percentages Of Subjects |
| MenACWY-CRM(Ad+) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenW (N=161,146,173) | 98 Percentages Of Subjects |
| MenACWY-CRM(Ad+) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenY (N=159, 147,177) | 97 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenY (N=159, 147,177) | 96 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenA (N=158,148,179) | 84 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenW (N=161,146,173) | 95 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenC (N=161,148,177) | 88 Percentages Of Subjects |
| MenACWY-PS | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenY (N=159, 147,177) | 84 Percentages Of Subjects |
| MenACWY-PS | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenC (N=161,148,177) | 71 Percentages Of Subjects |
| MenACWY-PS | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenW (N=161,146,173) | 88 Percentages Of Subjects |
| MenACWY-PS | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | MenA (N=158,148,179) | 46 Percentages Of Subjects |
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.p-value: <0.001Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.p-value: <0.001Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.p-value: <0.001Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.p-value: 0.003Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.p-value: <0.001Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.p-value: 0.071Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.p-value: <0.001Chi-squared
Comparison: To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.p-value: <0.001Chi-squared
Secondary
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
Time frame: 12 months after vaccination
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenA(N=140, 149) | 4.24 Titers |
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenC (N=140, 147) | 28 Titers |
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenW (N=138, 141) | 40 Titers |
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenY (N=139, 147) | 30 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenY (N=139, 147) | 13 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenA(N=140, 149) | 5.65 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenW (N=138, 141) | 17 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenC (N=140, 147) | 26 Titers |
Secondary
hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine
Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.
Time frame: 1 month after vaccination
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenA (N=158, 148, 179) | 34 Titers |
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenC (N=161, 148, 177) | 69 Titers |
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenW (161, 146, 173) | 61 Titers |
| MenACWY-CRM(Ad+) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenY (159,147,177) | 112 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenY (159,147,177) | 100 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenA (N=158, 148, 179) | 34 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenW (161, 146, 173) | 49 Titers |
| MenACWY-CRM(Ad-) | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenC (N=161, 148, 177) | 58 Titers |
| MenACWY-PS | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenY (159,147,177) | 34 Titers |
| MenACWY-PS | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenC (N=161, 148, 177) | 30 Titers |
| MenACWY-PS | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenW (161, 146, 173) | 30 Titers |
| MenACWY-PS | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | MenA (N=158, 148, 179) | 6.97 Titers |
Secondary
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.
Time frame: Day 1 to Day 7
Population: Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Local | 103 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Fever ≥ 38°C | 2 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Myalgia | 25 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Erythema | 33 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Arthralgia | 13 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Headache | 60 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Induration | 22 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Pain | 92 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Analgesic/Antipyretic Med Used | 44 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Systemic | 72 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Chills | 12 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Other | 44 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Nausea | 15 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Stayed home Due to a reaction | 2 Subjects |
| MenACWY-CRM(Ad+) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Malaise | 19 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Malaise | 14 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Fever ≥ 38°C | 3 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Systemic | 79 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Myalgia | 25 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Pain | 95 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Headache | 63 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Other | 45 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Arthralgia | 5 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Erythema | 28 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Nausea | 20 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Stayed home Due to a reaction | 2 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Analgesic/Antipyretic Med Used | 45 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Chills | 10 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Induration | 15 Subjects |
| MenACWY-CRM(Ad-) | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Local | 102 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Malaise | 23 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Local | 107 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Pain | 81 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Erythema | 57 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Induration | 34 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Systemic | 85 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Chills | 24 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Nausea | 22 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Myalgia | 35 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Arthralgia | 12 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Headache | 62 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Fever ≥ 38°C | 1 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Other | 40 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Analgesic/Antipyretic Med Used | 39 Subjects |
| MenACWY-PS | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Stayed home Due to a reaction | 6 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Nausea | 0 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Pain | 19 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Fever ≥ 38°C | 1 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Chills | 6 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Systemic | 23 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Local | 24 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Any Other | 14 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Induration | 8 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Injection Site Erythema | 11 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Stayed home Due to a reaction | 2 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Arthralgia | 2 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Myalgia | 5 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Analgesic/Antipyretic Med Used | 14 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Headache | 19 Subjects |
| MenACWY-PS -Stage 2 | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Malaise | 7 Subjects |
Secondary
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
Time frame: 12 months after vaccination
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad+) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenA (N=140, 149) | 36 Percentages Of Subjects |
| MenACWY-CRM(Ad+) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenC (N=140, 147) | 86 Percentages Of Subjects |
| MenACWY-CRM(Ad+) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenW (N=138, 141) | 95 Percentages Of Subjects |
| MenACWY-CRM(Ad+) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenY (N=139, 147) | 87 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenY (N=139, 147) | 63 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenA (N=140, 149) | 44 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenW (N=138, 141) | 72 Percentages Of Subjects |
| MenACWY-CRM(Ad-) | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | MenC (N=140, 147) | 69 Percentages Of Subjects |