Meningococcal Infections, Neisseria Meningitidis
Conditions
Keywords
N meningitidis
Brief summary
This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.
Interventions
BIOLOGICALMenactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
0.5 mL, Intramuscular
BIOLOGICALMencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, as determined by medical history and physical examination. * Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive). * For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment. * For the Control group, no previous history of any meningococcal vaccination. * Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old * Able to provide a vaccination log or has available vaccination record in the Health Center * Able to attend all scheduled visits and to comply with all trial procedures
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 oral temperature ≥ 37.5°C at the time of inclusion. * Administration of immune globulin or 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 provided that they have not received more than one course within the last two weeks prior to enrollment. * Oral or injected antibiotic therapy within the 72 hours prior to vaccination * Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination. * Previous history of documented invasive meningococcal disease. * Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances * Participation in another clinical trial in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine. * Personal or family history of Guillain Barré syndrome. * For female, known or suspected to be pregnant at the time of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Baseline (Day 0) and Day 28 after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Baseline (Day 0) and Day 28 After Vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Day 0 to Day 7 Post-vaccination |
Countries
Saudi Arabia
Participant flow
Recruitment details
Participants were enrolled from 17 February 2007, to 01 July 2007, in 7 clinic centers in Saudi Arabia.
Pre-assignment details
A total of 450 participants who met the inclusion and exclusion criteria were enrolled, and 446 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Group Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine. | 145 |
| Mencevax® Group Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine. | 142 |
| Control Group Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine. | 163 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 3 |
Baseline characteristics
| Characteristic | Mencevax® Group | Control Group | Menactra® Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 115 Participants | 134 Participants | 110 Participants | 359 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 29 Participants | 35 Participants | 91 Participants |
| Age, Continuous | 17.77 Years STANDARD_DEVIATION 1.15 | 17.85 Years STANDARD_DEVIATION 1.15 | 17.90 Years STANDARD_DEVIATION 1.2 | 17.84 Years STANDARD_DEVIATION 1.16 |
| Region of Enrollment Saudi Arabia | 142 participants | 163 participants | 145 participants | 450 participants |
| Sex: Female, Male Female | 78 Participants | 53 Participants | 78 Participants | 209 Participants |
| Sex: Female, Male Male | 64 Participants | 110 Participants | 67 Participants | 241 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 | 85 / 144 | 66 / 141 | 95 / 160 |
| serious Total, serious adverse events | 1 / 144 | 0 / 141 | 0 / 160 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Time frame: Baseline (Day 0) and Day 28 after vaccination
Population: Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup A (Day 28) | 4116.3 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup A (Baseline) | 651.5 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup C (Baseline) | 14.7 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup C (Day 28) | 288.3 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup Y (Baseline) | 78.8 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup Y (Day 28) | 2770.1 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup W-135 (Baseline) | 18.5 Titers (1/dil) |
| Menactra® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup W-135 (Day 28) | 2435.5 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup C (Baseline) | 15.8 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup W-135 (Baseline) | 24.5 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup C (Day 28) | 158.6 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup Y (Baseline) | 73.4 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup Y (Day 28) | 1936.3 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup A (Baseline) | 889.7 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup A (Day 28) | 3833.4 Titers (1/dil) |
| Mencevax® Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup W-135 (Day 28) | 1455.7 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup C (Baseline) | 16.8 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup Y (Day 28) | 4204.6 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup A (Day 28) | 6351.6 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup C (Day 28) | 993.4 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup W-135 (Baseline) | 8.1 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup A (Baseline) | 441.1 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup Y (Baseline) | 16.8 Titers (1/dil) |
| Control Group | Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination | Serogroup W-135 (Day 28) | 6926.7 Titers (1/dil) |
Secondary
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Time frame: Day 0 to Day 7 Post-vaccination
Population: Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Headache | 66 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Headache (Prevents daily activities) | 8 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Pain | 85 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Malaise | 61 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Erythema (≥ 5 cm) | 0 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Malaise (Prevents daily activities) | 8 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Myalgia | 60 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Myalgia (Prevents daily activities) | 10 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Swelling | 46 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Swelling (≥ 5 cm) | 0 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Pain (Incapacitating) | 10 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Solicited Systemic Reaction | 87 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Fever | 25 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Solicited Injection Site Reaction | 88 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Fever (> 39.0 ºC) | 3 Participants |
| Menactra® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Erythema | 39 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Pain (Incapacitating) | 3 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Erythema | 34 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Swelling | 29 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Headache (Prevents daily activities) | 6 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Solicited Injection Site Reaction | 71 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Headache | 64 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Malaise | 55 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Swelling (≥ 5 cm) | 0 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Fever | 17 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Malaise (Prevents daily activities) | 7 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Fever (> 39.0 ºC) | 1 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Myalgia | 55 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Erythema (≥ 5 cm) | 1 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Solicited Systemic Reaction | 86 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Myalgia (Prevents daily activities) | 8 Participants |
| Mencevax® Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Pain | 66 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Fever (> 39.0 ºC) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Solicited Injection Site Reaction | 98 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Pain | 95 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Pain (Incapacitating) | 9 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Erythema | 42 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Erythema (≥ 5 cm) | 2 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Injection Site Swelling | 34 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Injection Site Swelling (≥ 5 cm) | 4 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Solicited Systemic Reaction | 90 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Fever | 16 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Malaise (Prevents daily activities) | 6 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Headache | 60 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Headache (Prevents daily activities) | 8 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Malaise | 61 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Any Myalgia | 72 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination | Grade 3 Myalgia (Prevents daily activities) | 10 Participants |
Secondary
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Time frame: Baseline (Day 0) and Day 28 After Vaccination
Population: 4-Fold rise titers were determined in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup A | 66 Percentage of Participants |
| Menactra® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup C | 71 Percentage of Participants |
| Menactra® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup Y | 80 Percentage of Participants |
| Menactra® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup W-135 | 84 Percentage of Participants |
| Mencevax® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup W-135 | 72 Percentage of Participants |
| Mencevax® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup A | 62 Percentage of Participants |
| Mencevax® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup Y | 69 Percentage of Participants |
| Mencevax® Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup C | 57 Percentage of Participants |
| Control Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup W-135 | 96 Percentage of Participants |
| Control Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup C | 81 Percentage of Participants |
| Control Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup Y | 96 Percentage of Participants |
| Control Group | Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination | Serogroup A | 86 Percentage of Participants |