Meningococcal Disease
Conditions
Keywords
Meningitis, children, adolescents, adults, MenACWY
Brief summary
To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
Interventions
BIOLOGICALMenACWY-CRM
1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection
Sponsors
Novartis Vaccines
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Individuals eligible for enrollment in this study were those: 1. Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and: * the parent/legal representative had provided written informed consent (≥2 to \<18 years of age), * had provided written assent (≥11 to \<18 years of age), * had provided written informed consent (≥18 years of age onwards). 2. Who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit). 3. Who were in good health as determined by * medical history * physical exam * clinical judgment of the investigator 4. Who had a negative urine pregnancy test for female subjects from 11 years of age.
Exclusion criteria
Individuals not eligible to be enrolled in the study were those: 1. Who were unwilling or unable to give written informed assent or consent to participate in the study. 2. Who were perceived to be unreliable or unavailable for the duration of the study period. 3. Who had a previous confirmed or suspected disease caused by N meningitidis. 4. Who had household contact with and/or intimate exposure to an individual with culture-proven N meningitidis infection within 60 days prior to enrollment. 5. Who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). 6. Who were pregnant or breast feeding (female subjects). 7. Who had received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study. 8. Who had received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine might be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination). 9. Who had experienced within the 7 days prior to enrollment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment. 10. Who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). Who had epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 11. Who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components including diphtheria toxin (CRM-197) and latex in the syringe. 12. Who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose \> 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy) * receipt of immunostimulants * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study 13. Who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination | Day 29 | Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | Days 1 and 29 | Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group |
| Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | Days 1 and 29 | Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group |
| Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | Day 29 | Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM |
| Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Within days 1 through 7 postvaccination | Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group |
| Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29 | Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group |
| Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Within days 1 through 7 postvaccination | Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination |
Countries
Russia
Participant flow
Recruitment details
Subjects were enrolled at 5 centers in Russia
Pre-assignment details
All enrolled subjects were included in the study
Participants by arm
| Arm | Count |
|---|---|
| ≥2 to ≤10 Years Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM | 66 |
| ≥11 to ≤17 Years Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM | 66 |
| ≥18 Years Subjects ≥18 years of age who received one vaccination of MenACWY-CRM | 66 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years | Total |
|---|---|---|---|---|
| Age, Continuous | 6.0 year STANDARD_DEVIATION 2.7 | 13.8 year STANDARD_DEVIATION 2.1 | 38.8 year STANDARD_DEVIATION 12.5 | 19.6 year STANDARD_DEVIATION 15.9 |
| Sex: Female, Male FEMALE | 35 Participants | 29 Participants | 44 Participants | 108 Participants |
| Sex: Female, Male MALE | 31 Participants | 37 Participants | 22 Participants | 90 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 | 42 / 65 | 42 / 66 | 44 / 66 | 128 / 197 |
| serious Total, serious adverse events | 0 / 65 | 0 / 66 | 0 / 66 | 0 / 197 |
Outcome results
Primary
Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
Time frame: Day 29
Population: Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (≥2 Years) | Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination | MenA | 85 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination | MenC | 74 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination | MenW | 60 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination | MenY | 83 Percentage of subjects |
Secondary
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
Time frame: Days 1 and 29
Population: Analysis was done on FAS dataset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 93 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 4.07 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 111 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 12 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 58 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 59 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 2.93 human serum bactericidal assay titer |
| Overall (≥2 Years) | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 2.35 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 32 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 7.93 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 94 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 67 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 2.17 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 3.16 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 3.02 human serum bactericidal assay titer |
| ≥11 to ≤17 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 28 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 117 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 3.73 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 134 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 67 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 3.59 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 2.43 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 47 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 21 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 112 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 2.61 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 76 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 6.68 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 80 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 13 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 143 human serum bactericidal assay titer |
| ≥18 Years | Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 2.74 human serum bactericidal assay titer |
Secondary
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination
Time frame: Within days 1 through 7 postvaccination
Population: Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Erythema | 26 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Vomiting | 4 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Tenderness | 41 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Diarrhea | 11 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Sleepiness | 33 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Rash | 4 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Change in Eating Habits | 4 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Fever (≥38 °C) | 4 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Irritability | 26 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Use of analgesics/antipyretics | 7 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Induration | 19 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Use of analgesics/antipyretics | 0 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Induration | 17 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Change in Eating Habits | 6 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Tenderness | 39 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Erythema | 28 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Sleepiness | 28 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Irritability | 17 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Vomiting | 0 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Diarrhea | 11 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Rash | 6 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Fever (≥38 °C) | 6 Percentage of subjects |
Secondary
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group
Time frame: Within days 1 through 7 postvaccination
Population: Analysis was done on safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Myalgia | 19 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Arthralgia | 9 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Headache | 25 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Use of analgesic/antipyretics | 11 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Induration | 14 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Pain | 48 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Chills | 9 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Fever (≥38 °C) | 3 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Nausea | 8 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Malaise | 20 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Erythema | 18 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Rash | 2 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Fever (≥38 °C) | 5 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Myalgia | 13 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Erythema | 18 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Headache | 18 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Use of analgesic/antipyretics | 18 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Arthralgia | 3 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Pain | 42 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Chills | 8 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Rash | 3 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Malaise | 16 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Induration | 11 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Nausea | 3 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Chills | 8 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Pain | 50 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Erythema | 18 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Induration | 17 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Nausea | 11 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Malaise | 23 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Myalgia | 29 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Arthralgia | 11 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Headache | 27 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Rash | 0 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Fever (≥38 °C) | 3 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Use of analgesic/antipyretics | 9 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Malaise | 20 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Nausea | 8 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Pain | 50 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Rash | 5 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Chills | 12 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Induration | 12 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Use of analgesic/antipyretics | 9 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Fever (≥38 °C) | 2 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Arthralgia | 11 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Myalgia | 14 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Erythema | 17 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination | Headache | 27 Percentage of Subjects |
Secondary
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group
Time frame: AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29
Population: Analysis was done on safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (≥2 Years) | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Any AEs(days 1 through 7) | 17 percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related AEs (days 1 through 7) | 10 percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | SAE(days 1 through 29) | 0 percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related SAE(days 1 through 29) | 0 percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Medically attended AE(days 1 through 29) | 4 percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Premature withdrawal due to AE(days 1 through 29) | 0 percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Premature withdrawal due to AE(days 1 through 29) | 0 percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related SAE(days 1 through 29) | 0 percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Any AEs(days 1 through 7) | 20 percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | SAE(days 1 through 29) | 0 percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related AEs (days 1 through 7) | 3 percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Medically attended AE(days 1 through 29) | 8 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related AEs (days 1 through 7) | 9 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | SAE(days 1 through 29) | 0 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related SAE(days 1 through 29) | 0 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Premature withdrawal due to AE(days 1 through 29) | 0 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Medically attended AE(days 1 through 29) | 2 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Any AEs(days 1 through 7) | 12 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Medically attended AE(days 1 through 29) | 3 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Premature withdrawal due to AE(days 1 through 29) | 0 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related AEs (days 1 through 7) | 18 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | At least possibly related SAE(days 1 through 29) | 0 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | Any AEs(days 1 through 7) | 18 percentage of subjects |
| ≥18 Years | Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination | SAE(days 1 through 29) | 0 percentage of subjects |
Secondary
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
Time frame: Days 1 and 29
Population: Analysis was done on FAS dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 6 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 89 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 26 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 84 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 57 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 97 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 16 Percentage of Subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 88 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 95 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 30 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 89 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 79 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 10 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 76 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 13 Percentage of Subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 2 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 15 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 17 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 86 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 71 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 98 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 94 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 5 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 92 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 1) | 49 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenC (Day 29) | 89 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 29) | 85 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenA (Day 1) | 11 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 1) | 69 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 29) | 89 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenY (Day 1) | 22 Percentage of Subjects |
| ≥18 Years | Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination | MenW (Day 29) | 97 Percentage of Subjects |
Secondary
Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM
Time frame: Day 29
Population: Analysis was done on FAS dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (≥2 Years) | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenA | 89 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenC | 69 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenW | 73 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenY | 77 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenY | 88 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenA | 89 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenW | 51 Percentage of subjects |
| ≥11 to ≤17 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenC | 82 Percentage of subjects |
| ≥18 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenY | 85 Percentage of subjects |
| ≥18 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenC | 71 Percentage of subjects |
| ≥18 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenW | 57 Percentage of subjects |
| ≥18 Years | Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group | MenA | 77 Percentage of subjects |