Meningitis, Meningococcal Infection, Neisseria Meningitidis
Conditions
Keywords
Meningitis; Meningococcal infection, Neisseria meningitidis
Brief summary
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
Detailed description
This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.
Interventions
BIOLOGICALMenactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses 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
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 2 to \< 11 years on the day of inclusion. * Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative. * Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.
Exclusion criteria
: * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine. * Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine . * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Receipt of blood or blood-derived products in the past 3 months. * Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s). * Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity. * History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically). * Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination. * Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws. * Personal or family history of Guillain-Barré Syndrome (GBS). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | 30 days post-vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | 30 days post-vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) |
| Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | 30 days post-vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) |
| Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | 7 days post-vaccination 1 | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. |
| Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | 7 days post-vaccination 2 | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 17 June 2008 to 25 July 2008 in 13 of 15 medical centers in the US.
Pre-assignment details
A total of 333 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Group 1 Participants aged 2 to less than 4 years who received 2 doses of vaccine | 111 |
| Menactra® Group 2 Participants aged 4 to less than 6 years who received 2 doses of vaccine | 111 |
| Menactra® Group 3 Participants aged 6 to less than 11 years who received a single dose of vaccine | 111 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 | 0 |
| Overall Study | Protocol Violation | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 3 | 1 |
Baseline characteristics
| Characteristic | Menactra® Group 2 | Menactra® Group 3 | Menactra® Group 1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 111 Participants | 111 Participants | 111 Participants | 333 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Age Continuous | 4.46 Years STANDARD_DEVIATION 0.5 | 8.05 Years STANDARD_DEVIATION 1.31 | 2.46 Years STANDARD_DEVIATION 0.5 | 4.99 Years STANDARD_DEVIATION 2.47 |
| Region of Enrollment United States | 111 participants | 111 participants | 111 participants | 333 participants |
| Sex: Female, Male Female | 55 Participants | 53 Participants | 50 Participants | 158 Participants |
| Sex: Female, Male Male | 56 Participants | 58 Participants | 61 Participants | 175 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 | 58 / 111 | 57 / 111 | 64 / 111 |
| serious Total, serious adverse events | 4 / 111 | 3 / 111 | 0 / 111 |
Outcome results
Primary
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time frame: 30 days post-vaccination
Population: Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0] | 96 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108] | 66 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108] | 72 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0] | 83 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107] | 59 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0] | 95 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0] | 100 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108] | 60 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107] | 36 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108] | 65 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0] | 96 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108] | 79 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0] | 96 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0] | 67 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108] | 51 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0] | 88 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107] | 65 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108] | 62 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108] | 71 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108] | 91 Percentage of Participants |
Secondary
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time frame: 30 days post-vaccination
Population: Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup A Post-dose 2 [n = 81, 89, 0] | 24.3 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup A Post-dose 1 [n = 82, 89, 107] | 9.97 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup C Post-dose 2 [n = 82, 89, 0] | 92.8 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup W-135 Post-dose 2 [n = 82, 89, 0] | 57.8 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup W-135 Post-dose 1 [n = 82, 89, 108] | 12.4 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup Y Post-dose 1 [n = 82, 89, 108] | 8.42 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup C Post-dose 1 [n = 82, 89, 108] | 13.4 Titers |
| Menactra® Group 1 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup Y Post-dose 2 [n = 82, 89, 0] | 78.4 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup W-135 Post-dose 1 [n = 82, 89, 108] | 15.5 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup Y Post-dose 2 [n = 82, 89, 0] | 42.0 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup A Post-dose 2 [n = 81, 89, 0] | 13.6 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup W-135 Post-dose 2 [n = 82, 89, 0] | 50.3 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup C Post-dose 1 [n = 82, 89, 108] | 8.99 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup C Post-dose 2 [n = 82, 89, 0] | 46.1 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup A Post-dose 1 [n = 82, 89, 107] | 5.59 Titers |
| Menactra® Group 2 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup Y Post-dose 1 [n = 82, 89, 108] | 9.13 Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup W-135 Post-dose 2 [n = 82, 89, 0] | NA Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup A Post-dose 1 [n = 82, 89, 107] | 12.7 Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup C Post-dose 1 [n = 82, 89, 108] | 18.5 Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup C Post-dose 2 [n = 82, 89, 0] | NA Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup Y Post-dose 1 [n = 82, 89, 108] | 14.2 Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup Y Post-dose 2 [n = 82, 89, 0] | NA Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup W-135 Post-dose 1 [n = 82, 89, 108] | 24.1 Titers |
| Menactra® Group 3 | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Serogroup A Post-dose 2 [n = 81, 89, 0] | NA Titers |
Secondary
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time frame: 7 days post-vaccination 1
Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Swelling (≥ 5 cm) | 4 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Solicited Injection Site Reaction Post Dose 1 | 67 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Pain (Incapacitating) | 1 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Erythema | 47 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Erythema (≥ 5 cm) | 5 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Swelling | 23 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Pain | 53 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Solicited Systemic Reaction Post Dose 1 | 52 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Fever | 7 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) | 1 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Headache | 7 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Headache (Prevents daily activities) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Vomiting | 6 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Vomiting (≥ 3 episodes per 24 hours) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Drowsiness | 21 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Drowsiness (Disabling) | 1 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Anorexia | 20 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Anorexia (Skips ≥ 3 meals) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Irritability | 35 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Irritability (>3 hours duration) | 2 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Arthralgia | 7 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Arthralgia (Unwllling to move due to pain) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Diarrhea | 17 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Diarrhea (≥ 5 episodes per 24 hours) | 2 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Arthralgia (Unwllling to move due to pain) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Anorexia | 10 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Solicited Injection Site Reaction Post Dose 1 | 60 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Vomiting | 4 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Pain | 53 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Headache | 15 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Arthralgia | 8 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Pain (Incapacitating) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Vomiting (≥ 3 episodes per 24 hours) | 1 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Diarrhea | 8 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Erythema | 27 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) | 1 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Anorexia (Skips ≥ 3 meals) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Erythema (≥ 5 cm) | 4 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Drowsiness | 16 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Headache (Prevents daily activities) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Swelling | 18 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Fever | 4 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Diarrhea (≥ 5 episodes per 24 hours) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Swelling (≥ 5 cm) | 3 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Drowsiness (Disabling) | 4 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Irritability | 20 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Solicited Systemic Reaction Post Dose 1 | 43 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Irritability (>3 hours duration) | 4 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Solicited Systemic Reaction Post Dose 1 | 38 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Fever | 1 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) | 0 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Headache | 23 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Irritability (>3 hours duration) | 2 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Headache (Prevents daily activities) | 0 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Diarrhea | 3 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Vomiting | 2 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Vomiting (≥ 3 episodes per 24 hours) | 0 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Arthralgia | 7 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Drowsiness | 14 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Diarrhea (≥ 5 episodes per 24 hours) | 0 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Drowsiness (Disabling) | 0 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Solicited Injection Site Reaction Post Dose 1 | 67 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Pain | 58 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Anorexia | 7 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Pain (Incapacitating) | 2 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Arthralgia (Unwllling to move due to pain) | 1 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Erythema | 32 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Erythema (≥ 5 cm) | 8 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Anorexia (Skips ≥ 3 meals) | 0 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Swelling | 23 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Grade 3 Swelling (≥ 5 cm) | 5 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Any Irritability | 11 Percentage of Participants |
Secondary
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time frame: 7 days post-vaccination 2
Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Erythema (≥ 5 cm) | 8 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Headache (Prevents daily activities) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Solicited Injection Site Reaction Post Dose 2 | 60 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Vomiting (≥ 3 episodes per 24 hours) | 1 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Swelling | 20 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Drowsiness | 19 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Pain (Incapacitating) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Drowsiness (Disabling) | 1 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Swelling (≥ 5 cm) | 3 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Anorexia | 21 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Vomiting | 5 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Anorexia (Skips ≥ 3 meals) | 1 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Solicited Systemic Reaction Post Dose 2 | 53 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Irritability | 31 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Irritability (>3 hours duration) | 5 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Fever | 5 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Arthralgia | 8 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Erythema | 37 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Arthralgia (Unwllling to move due to pain) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Diarrhea | 15 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Pain | 48 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Diarrhea (≥ 5 episodes per 24 hours) | 0 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Headache | 6 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Diarrhea (≥ 5 episodes per 24 hours) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Headache (Prevents daily activities) | 1 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Irritability | 23 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Solicited Injection Site Reaction Post Dose 2 | 64 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Pain | 52 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Pain (Incapacitating) | 1 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Erythema | 36 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Erythema (≥ 5 cm) | 4 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Swelling | 15 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Swelling (≥ 5 cm) | 2 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Fever | 13 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) | 3 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Headache | 14 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Vomiting | 7 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Vomiting (≥ 3 episodes per 24 hours) | 2 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Drowsiness | 18 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Drowsiness (Disabling) | 2 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Anorexia | 17 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Anorexia (Skips ≥ 3 meals) | 1 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Irritability (>3 hours duration) | 3 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Arthralgia | 7 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Grade 3 Arthralgia (Unwllling to move due to pain) | 0 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Diarrhea | 7 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Any Solicited Systemic Reaction Post Dose 2 | 49 Percentage of Participants |
Secondary
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time frame: 30 days post-vaccination
Population: Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup C Post-dose 1 ≥ 4 [n = 82, 89, 108] | 78 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup C Post-dose 2 ≥ 4 [n = 82, 89, 0] | 95 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup W-135 Post-dose 2 ≥ 4 [n = 82, 89, 0] | 99 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup Y Post-dose 1 ≥ 4 [n = 82, 89, 108] | 77 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup W-135 Post-dose 1 ≥ 4 [n = 82, 89, 108] | 83 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup A Post-dose 2 ≥ 4 [n = 81, 89, 0] | 94 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup A Post-dose 1 ≥ 4 [n = 82, 89, 107] | 73 Percentage of Participants |
| Menactra® Group 1 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup Y Post-dose 2 ≥ 4 [n = 82, 89, 0] | 100 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup C Post-dose 1 ≥ 4 [n = 82, 89, 108] | 63 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup A Post-dose 1 ≥ 4 [n = 82, 89, 107] | 58 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup A Post-dose 2 ≥ 4 [n = 81, 89, 0] | 79 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup C Post-dose 2 ≥ 4 [n = 82, 89, 0] | 91 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup Y Post-dose 1 ≥ 4 [n = 82, 89, 108] | 83 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup Y Post-dose 2 ≥ 4 [n = 82, 89, 0] | 98 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup W-135 Post-dose 1 ≥ 4 [n = 82, 89, 108] | 89 Percentage of Participants |
| Menactra® Group 2 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup W-135 Post-dose 2 ≥ 4 [n = 82, 89, 0] | 100 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup C Post-dose 1 ≥ 4 [n = 82, 89, 108] | 69 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup Y Post-dose 2 ≥ 4 [n = 82, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup A Post-dose 1 ≥ 4 [n = 82, 89, 107] | 79 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup W-135 Post-dose 2 ≥ 4 [n = 82, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup C Post-dose 2 ≥ 4 [n = 82, 89, 0] | NA Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup W-135 Post-dose 1 ≥ 4 [n = 82, 89, 108] | 96 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup Y Post-dose 1 ≥ 4 [n = 82, 89, 108] | 83 Percentage of Participants |
| Menactra® Group 3 | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Serogroup A Post-dose 2 ≥ 4 [n = 81, 89, 0] | NA Percentage of Participants |