Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis, Meningococcal infection, Neisseria meningitidis, Menactra®, Menomune®
Brief summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is healthy, as determined by medical history. * Subject is between the ages of 15 and 23 years (not yet 24 years). * For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. * Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study) * Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form. * Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications * A negative urine pregnancy test is required for menstruating female subjects.
Exclusion criteria
* History of documented invasive meningococcal disease. * Received any other meningococcal vaccine * Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment * Scheduled to receive any vaccination in the 28-day period after enrollment * Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample * Actively enrolled or scheduled to be enrolled in another clinical study * Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system) * Known or suspected impairment of immunologic function * Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion * Administration of immune globulin, other blood products, or corticosteroid within 3 months of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * Personal or family history of Guillain-Barre Syndrome * Suspected or known hypersensitivity to any of the vaccine components * Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures * Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) | Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Day 0 to 7 post-vaccination | Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 20 December 2005 to 31 May 2006, in 8 United States clinical sites.
Pre-assignment details
A total of 145 participants who participated in a previous study MTA02 and other meningococcal-vaccine naive participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Vaccine Group 1 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. | 9 |
| Menactra® Vaccine Group 2 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. | 18 |
| Meningococcal Vaccine-naive Group 3 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination | 58 |
| Meningococcal Vaccine-naive Group 4 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. | 60 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Missed post-vaccination blood draw | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 5 | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Menactra® Vaccine Group 2 | Meningococcal Vaccine-naive Group 3 | Menactra® Vaccine Group 1 | Meningococcal Vaccine-naive Group 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 53 Participants | 5 Participants | 54 Participants | 122 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 5 Participants | 4 Participants | 6 Participants | 23 Participants |
| Age, Continuous | 18.8 years STANDARD_DEVIATION 1.86 | 16.4 years STANDARD_DEVIATION 1.38 | 18.1 years STANDARD_DEVIATION 1.62 | 16.6 years STANDARD_DEVIATION 1.81 | 17.9 years STANDARD_DEVIATION 2.24 |
| Region of Enrollment United States | 18 participants | 58 participants | 9 participants | 60 participants | 145 participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 5 Participants | 28 Participants | 73 Participants |
| Sex: Female, Male Male | 5 Participants | 31 Participants | 4 Participants | 32 Participants | 72 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 | 1 / 9 | 5 / 18 | 32 / 58 | 23 / 60 |
| serious Total, serious adverse events | 0 / 9 | 0 / 18 | 0 / 58 | 0 / 60 |
Outcome results
Primary
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.
Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.
Time frame: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)
Population: SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 0 | 4 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 28 | 4 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 0 | 2 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 28 | 4 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 0 | 3 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 28 | 4 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 0 | 3 Participants |
| Menactra® Vaccine Group 1 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 28 | 4 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 28 | 12 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 0 | 12 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 28 | 12 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 28 | 12 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 0 | 12 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 28 | 12 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 0 | 8 Participants |
| Menactra® Vaccine Group 2 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 0 | 12 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 0 | 25 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 0 | 15 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 28 | 56 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 0 | 49 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 28 | 57 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 28 | 57 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 0 | 25 Participants |
| Meningococcal Vaccine-naive Group 3 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 28 | 56 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 0 | 20 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - Day 28 | 60 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 28 | 60 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - Day 0 | 25 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 0 | 52 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 28 | 60 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - Day 0 | 28 Participants |
| Meningococcal Vaccine-naive Group 4 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - Day 28 | 60 Participants |
Other Pre-specified
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions
Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time frame: Day 0 to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Fever | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Injection Site Pain (Incapacitating) | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Injection Site Pain | 2 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Myalgia | 2 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Erythema (≥ 2 inches) | 1 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Erythema | 2 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Malaise | 1 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Swelling | 1 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Headache | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| Menactra® Vaccine Group 1 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Swelling (≥ 2 inches) | 1 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Swelling (≥ 2 inches) | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Erythema | 2 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Erythema (≥ 2 inches) | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Swelling | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Injection Site Pain | 8 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Injection Site Pain (Incapacitating) | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Fever | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Headache | 5 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Malaise | 3 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Myalgia | 6 Participants |
| Menactra® Vaccine Group 2 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Fever | 2 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Swelling | 12 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Myalgia | 24 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Headache | 20 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Erythema | 13 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Malaise | 15 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Erythema (≥ 2 inches) | 1 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Injection Site Pain | 36 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Injection Site Pain (Incapacitating) | 0 Participants |
| Meningococcal Vaccine-naive Group 3 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Swelling (≥ 2 inches) | 1 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Swelling | 3 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Malaise | 22 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Erythema | 14 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Injection Site Pain (Incapacitating) | 0 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Fever | 0 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Headache | 28 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Myalgia | 28 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Any Injection Site Pain | 37 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Erythema (≥ 2 inches) | 0 Participants |
| Meningococcal Vaccine-naive Group 4 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Grade 3 Swelling (≥ 2 inches) | 0 Participants |