Meningococcal Disease, Meningococcal Meningitis, Hepatitis A, Hepatitis B
Conditions
Keywords
meningococcal, conjugate, vaccine, adults
Brief summary
This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
Interventions
BIOLOGICALMenACWY-CRM
Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
BIOLOGICALCombined inactivated hepatitis A & recombinant hepatitis B
Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 & 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.
BIOLOGICALRecombinant hepatitis B vaccine
Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
BIOLOGICALInactivated hepatitis A vaccine
Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
Sponsors
GlaxoSmithKline
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were: 1. Between 18 and 64 years of age inclusive and who had given their written informed consent; 2. Available for all visits and telephone calls scheduled for the study; 3. In good health as determined by medical history, physical examination and clinical judgment of the investigator; 4. For female subjects, had a negative urine pregnancy test.
Exclusion criteria
Individuals not eligible to be enrolled in the study were those: 1. Who were breastfeeding. 2. Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection. 3. Who received previous immunization with any meningococcal vaccine. 4. Who received previous hepatitis A and/or B vaccination, determined by history (interview of the subject) and/or by review of his or her vaccination card, if less than 5 years have elapsed since vaccination. 5. Who received investigational agents or vaccines within 30 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to completion of the study. 6. Who received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine was anticipated during the study period (Exception: Influenza vaccine might have been administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization). 7. Who 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. 8. Who had any serious acute, chronic or progressive disease such as: * History of cancer * Complicated diabetes mellitus * Advanced arteriosclerotic disease * Autoimmune disease * HIV infection or AIDS * Blood dyscrasias * Congestive heart failure * Renal failure * Severe malnutrition (Note: Subjects with mild asthma were eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment). 9. Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome. 10. Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy and antibiotic allergy. 11. 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 (systemic corticosteroids 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. 12. Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time. 13. Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives. 14. Who were part of the study personnel or close family members of those conducting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination. | Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | 28 days post primary or booster vaccination. | Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination. |
| Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | 28 days postvaccination (day 29). | Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone. For a subject with a baseline hSBA titer \< 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | 28 days post vaccination (day 29). | Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone. |
| Percentages of Subjects With Unsolicited Adverse Events (AEs) | Day 1 to day 57. | Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57). |
Countries
Germany
Participant flow
Recruitment details
Subjects were enrolled at four centers in Germany.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| HepA/B Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine. | 84 |
| HepA/B+MenACWY-CRM Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine. | 84 |
| MenACWY-CRM Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine. | 84 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | HepA/B | HepA/B+MenACWY-CRM | MenACWY-CRM | Total |
|---|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 12.3 | 39.9 years STANDARD_DEVIATION 12.6 | 39.7 years STANDARD_DEVIATION 11 | 39.5 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 45 Participants | 40 Participants | 50 Participants | 135 Participants |
| Sex: Female, Male Male | 39 Participants | 44 Participants | 34 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 84 | 21 / 85 | 12 / 83 |
| serious Total, serious adverse events | 1 / 84 | 0 / 85 | 1 / 83 |
Outcome results
Primary
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
Time frame: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Population: Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HepA/B+MenACWY-CRM | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | Prevaccination AntiHAV | 48 Concentrations (mIU/mL) |
| HepA/B+MenACWY-CRM | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | 28 days after primary or booster AntiHAV | 786 Concentrations (mIU/mL) |
| HepA/B+MenACWY-CRM | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | Prevaccination AntiHBV (N=78, 76) | 22 Concentrations (mIU/mL) |
| HepA/B+MenACWY-CRM | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | 28 days after primary or booster AntiHBV (N=78,76) | 844 Concentrations (mIU/mL) |
| HepA/B | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | 28 days after primary or booster AntiHBV (N=78,76) | 711 Concentrations (mIU/mL) |
| HepA/B | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | Prevaccination AntiHAV | 30 Concentrations (mIU/mL) |
| HepA/B | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | Prevaccination AntiHBV (N=78, 76) | 31 Concentrations (mIU/mL) |
| HepA/B | Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination | 28 days after primary or booster AntiHAV | 884 Concentrations (mIU/mL) |
Comparison: The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.95% CI: [0.6, 1.32]ANCOVA
Comparison: The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.95% CI: [0.59, 2.37]ANCOVA
Secondary
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.
Time frame: 28 days post vaccination (day 29).
Population: Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men C Human Complement SBA; Day 29 (N=83, 83) | 75 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men A Human Complement SBA; Day 29 (N=83, 82) | 43 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men W Human Complement SBA; Day 1 (N=84, 83) | 30 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men A Human Complement SBA; Day 1 (N= 84, 84) | 2.68 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men W Human Complement SBA; Day 29 (N=83, 83) | 110 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men C Human Complement SBA; Day 1 (N= 84, 84) | 7.39 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men Y Human Complement SBA; Day 1 (N= 84, 84) | 6.63 Titers |
| HepA/B+MenACWY-CRM | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men Y Human Complement SBA; Day 29 (N=83, 83) | 78 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men Y Human Complement SBA; Day 29 (N=83, 83) | 62 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men A Human Complement SBA; Day 1 (N= 84, 84) | 2.71 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men A Human Complement SBA; Day 29 (N=83, 82) | 36 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men C Human Complement SBA; Day 1 (N= 84, 84) | 6.35 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men C Human Complement SBA; Day 29 (N=83, 83) | 56 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men W Human Complement SBA; Day 1 (N=84, 83) | 31 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men W Human Complement SBA; Day 29 (N=83, 83) | 109 Titers |
| HepA/B | hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 | Men Y Human Complement SBA; Day 1 (N= 84, 84) | 5.56 Titers |
Secondary
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.
Time frame: 28 days post primary or booster vaccination.
Population: Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HepA/B+MenACWY-CRM | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | AntiHAV antibody concentration ≥20mIU/mL (Day 1) | 42 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | 28 days after primary/booster AntiHAV | 96 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | AntiHBsAg antibody concentration ≥10mIU/mL (Day 1) | 47 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | 28 days after primary/booster AntiHBV | 75 percentage of subjects |
| HepA/B | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | 28 days after primary/booster AntiHBV | 80 percentage of subjects |
| HepA/B | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | AntiHAV antibody concentration ≥20mIU/mL (Day 1) | 33 percentage of subjects |
| HepA/B | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | AntiHBsAg antibody concentration ≥10mIU/mL (Day 1) | 44 percentage of subjects |
| HepA/B | Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination | 28 days after primary/booster AntiHAV | 99 percentage of subjects |
Secondary
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone. For a subject with a baseline hSBA titer \< 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 28 days postvaccination (day 29).
Population: Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HepA/B+MenACWY-CRM | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenA-hSBA Overall Seroresponse (N=83, 82) | 71 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenC-hSBA Overall Seroresponse | 66 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenW-hSBA Overall Seroresponse (N=83, 82) | 40 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenY-hSBA Overall Seroresponse | 70 percentage of subjects |
| HepA/B | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenY-hSBA Overall Seroresponse | 64 percentage of subjects |
| HepA/B | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenA-hSBA Overall Seroresponse (N=83, 82) | 65 percentage of subjects |
| HepA/B | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenW-hSBA Overall Seroresponse (N=83, 82) | 34 percentage of subjects |
| HepA/B | Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 | MenC-hSBA Overall Seroresponse | 59 percentage of subjects |
Secondary
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).
Time frame: Day 1 to day 57.
Population: Analysis was done on safety set- subjects who provided any post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HepA/B+MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | AE leading to withdrawal | 0 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Any AE | 43 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Death | 0 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Atleast possibly related AE | 23 percentage of subjects |
| HepA/B+MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Any SAE | 1 percentage of subjects |
| HepA/B | Percentages of Subjects With Unsolicited Adverse Events (AEs) | AE leading to withdrawal | 1 percentage of subjects |
| HepA/B | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Atleast possibly related AE | 27 percentage of subjects |
| HepA/B | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Any AE | 39 percentage of subjects |
| HepA/B | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Death | 0 percentage of subjects |
| HepA/B | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Any SAE | 0 percentage of subjects |
| MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Death | 1 percentage of subjects |
| MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Any SAE | 1 percentage of subjects |
| MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Any AE | 36 percentage of subjects |
| MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | Atleast possibly related AE | 17 percentage of subjects |
| MenACWY-CRM | Percentages of Subjects With Unsolicited Adverse Events (AEs) | AE leading to withdrawal | 1 percentage of subjects |