Meningitis, Meningococcemia, Neisseria Meningitidis
Conditions
Keywords
Menactra®, Menomune®, Meningitis, Meningococcemia, Neisseria meningitidis
Brief summary
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier. Primary Objective: To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.
Detailed description
This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.
Interventions
0.05 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
: * Stage I * Participant is healthy, as determined by medical history and physical examination. * Participant is at least 3 years of age but not yet 6 years of age at the enrolment. * For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment * For the Control group: no previous history of any meningococcal vaccination * Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form. * Stage II * Participant is healthy, as determined by medical history and physical examination. * Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage 1. * Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage 1. * Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
Exclusion criteria
: * Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc.) * Known or suspected impairment of immunologic function * Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 99.5ºF \[≥ 37.5ºC\]) at the time of inclusion * For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-02. * For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior. * Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks 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. * Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn * Received any vaccine in the 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial. * 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 * Enrolled in another clinical trial * Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Day 0 and Days 8 and 28 post-vaccination |
Other
| Measure | Time frame |
|---|---|
| Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Baseline to Day 8 and Day 28 post-vaccination |
| Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Day 0 to 7 post-vaccination |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 10 march through 13 June 2003 in 8 US clinic sites
Pre-assignment details
A total of 173 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Previously Received TetraMenD Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02. | 100 |
| Meningococcal Vaccine-naive Participants have never received a Meningococcal vaccine in the past. | 71 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 8 |
| Overall Study | Vaccination error-wrong dose/expired lot | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Meningococcal Vaccine-naive | Previously Received TetraMenD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 71 Participants | 100 Participants | 171.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Continuous | 3.8 years STANDARD_DEVIATION 0.87 | 4.5 years STANDARD_DEVIATION 0.52 | 4.2 years STANDARD_DEVIATION 0.76 |
| Region of Enrollment United States | 71 participants | 100 participants | 171.0 participants |
| Sex: Female, Male Female | 44 Participants | 42 Participants | 86.0 Participants |
| Sex: Female, Male Male | 27 Participants | 58 Participants | 85.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 100 | 33 / 71 |
| serious Total, serious adverse events | 0 / 100 | 0 / 71 |
Outcome results
Primary
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Time frame: Day 0 and Days 8 and 28 post-vaccination
Population: Geometric mean titers were determined in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup A (Day 0) | 316.1 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup A (Day 8) | 11411.9 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup A (Day 28) | 5620.6 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup C (Day 0) | 68.4 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup C (Day 8) | 8700.9 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup C (Day 28) | 7261.6 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup Y (Day 0) | 411.5 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup Y (Day 8) | 7261.6 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup Y (Day 28) | 3798.7 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup W-135 (Day 0) | 92.5 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup W-135 (Day 8) | 11761.1 Titers |
| Previously Received TetraMenD | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup W-135 (Day 28) | 6245.9 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup W-135 (Day 8) | 5194.8 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup A (Day 0) | 126.5 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup Y (Day 0) | 241.8 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup A (Day 8) | 6720.1 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup W-135 (Day 0) | 17.5 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup A (Day 28) | 2603.3 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup Y (Day 8) | 3859.7 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup C (Day 0) | 21.2 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup W-135 (Day 28) | 2103.3 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup C (Day 8) | 2447.5 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup Y (Day 28) | 1410.0 Titers |
| Meningococcal Vaccine-naive | Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. | Meningococcal Serogroup C (Day 28) | 300.4 Titers |
Other Pre-specified
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Time frame: Day 0 to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Induration | 14 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Grade 3 Solicited Local Reaction (Days 0-7) | 0 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Redness | 23 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Redness (>2 inch) | 0 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Swelling | 11 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Swelling (>2 inch) | 0 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Solicited Local Reaction (Days 0-7) | 46 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Induration (>2 inch) | 0 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Pain | 34 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Pain (Disabling, unable to move arm) | 0 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Solicited Systemic Reaction (Days 0-7) | 38 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Grade 3 Solicited Systemic Reaction (Days 0-7) | 3 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Fever | 10 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Fever (≥ 40.0°C) | 0 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Fussiness | 22 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Fussiness (Irritability for > 3 hours) | 1 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Drowsiness | 17 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grd 3 Drowsiness: not interested in usual activity | 1 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Anorexia | 8 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Anorexia (Skipped ≥ 3 meals) | 1 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Vomiting | 5 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Vomiting (≥ 3 episodes) | 2 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Diarrhea | 6 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Diarrhea (≥ 5 episodes) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Diarrhea | 9 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Solicited Local Reaction (Days 0-7) | 45 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Fever | 3 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Grade 3 Solicited Local Reaction (Days 0-7) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Anorexia | 13 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Redness | 20 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Fever (≥ 40.0°C) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Redness (>2 inch) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Vomiting (≥ 3 episodes) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Swelling | 15 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Fussiness | 30 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Swelling (>2 inch) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Anorexia (Skipped ≥ 3 meals) | 1 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Induration | 13 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Fussiness (Irritability for > 3 hours) | 1 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Induration (>2 inch) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Diarrhea (≥ 5 episodes) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Pain | 33 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Drowsiness | 12 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grade 3 Pain (Disabling, unable to move arm) | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Vomiting | 0 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Solicited Systemic Reaction (Days 0-7) | 42 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Grd 3 Drowsiness: not interested in usual activity | 1 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. | Any Grade 3 Solicited Systemic Reaction (Days 0-7) | 4 Percentage of participants |
Other Pre-specified
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Time frame: Baseline to Day 8 and Day 28 post-vaccination
Population: Fold rise analysis was assessed in per-protocol population with valid serology data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup A (Day 8) | 93 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup C (Day 8) | 91 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup Y (Day 8) | 96 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup W-135 (Day 8) | 98 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup A (Day 28) | 72 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup C (Day 28) | 93 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup Y (Day 28) | 78 Percentage of participants |
| Previously Received TetraMenD | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup W-135 (Day 28) | 93 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup W-135 (Day 28) | 100 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup A (Day 8) | 89 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup A (Day 28) | 85 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup C (Day 8) | 89 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup Y (Day 28) | 65 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup Y (Day 8) | 74 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup C (Day 28) | 54 Percentage of participants |
| Meningococcal Vaccine-naive | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. | Meningococcal Serogroup W-135 (Day 8) | 100 Percentage of participants |