Meningitis, Meningococcemia
Conditions
Keywords
Meningitis, Meningococcemia, Neisseria meningitidis, Menactra®
Brief summary
Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: * To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. * To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. * To describe the safety profile of a single dose of Menactra® vaccine in subjects.
Detailed description
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.
Interventions
0.5 mL, IM
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 6 Years
Healthy volunteers
Yes
Inclusion criteria
: * Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received * At 3 to \< 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine). * Informed consent form signed and dated by the parent(s) or another legally acceptable representative. * Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.
Exclusion criteria
: * 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 study 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. * Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or 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. * Received 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 study vaccination. * Planned receipt of any vaccine within the 4 weeks following the study vaccination. * 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 Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 30 post-vaccination | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Day 0 (pre-vaccination) and Day 30 post-vaccination | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). |
| Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Day 0 up to Day 7 post-vaccination | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) -\>39.0˚C (\>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - \>3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 17 June 2008 to 01 October 2008 at 13 clinical centers in the United States.
Pre-assignment details
A total of 181 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| One-Dose Menactra Group Participants received one dose of Menactra® in Study MTA26. | 48 |
| Two-Dose Menactra Group Participants received two doses of Menactra® in Study MTA26 | 66 |
| Menactra-naïve Group Participants had never received Menactra® vaccine. | 67 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Two-Dose Menactra Group | Menactra-naïve Group | One-Dose Menactra Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 66 Participants | 67 Participants | 48 Participants | 181 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 | 51.6 Months STANDARD_DEVIATION 1.96 | 52.5 Months STANDARD_DEVIATION 11.8 | 57.4 Months STANDARD_DEVIATION 2.89 | 53.4 Months STANDARD_DEVIATION 7.75 |
| Region of Enrollment United States | 66 Participants | 67 Participants | 48 Participants | 181 Participants |
| Sex: Female, Male Female | 38 Participants | 22 Participants | 20 Participants | 80 Participants |
| Sex: Female, Male Male | 28 Participants | 45 Participants | 28 Participants | 101 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 | 26 / 48 | 43 / 66 | 41 / 67 |
| serious Total, serious adverse events | 0 / 48 | 0 / 66 | 0 / 67 |
Outcome results
Primary
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Population: Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 0, ≥1:4 (n=41, 63, 61) | 29.3 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 0, ≥1:8 (n=41, 63, 61) | 48.8 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 30, ≥1:4 (n=40, 62, 59) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 30, ≥1:8 (n=40, 62, 59) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 0, ≥1:4 (n=41, 63, 61) | 70.7 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 0, ≥1:8 (n=41, 63, 61) | 22.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 30, ≥1:4 (n=41, 63, 59) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 30, ≥1:8 (n=41, 63, 59) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 0, ≥1:4 (n=41, 63, 61) | 31.7 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 0, ≥1:8 (n=41, 63, 61) | 14.6 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 30, ≥1:4 (n=40, 63, 60) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 30, ≥1:8 (n=40, 63, 60) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 0, ≥1:4 (n=41, 63, 61) | 43.9 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 0, ≥1:8 (n=41, 63, 61) | 29.3 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 30, ≥1:4 (n=40, 63, 60) | 100.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 30, ≥1:8 (n=40, 63, 60) | 100.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 0, ≥1:8 (n=41, 63, 61) | 12.7 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 30, ≥1:4 (n=41, 63, 59) | 98.4 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 30, ≥1:8 (n=41, 63, 59) | 98.4 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 0, ≥1:8 (n=41, 63, 61) | 22.2 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 0, ≥1:4 (n=41, 63, 61) | 33.3 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 0, ≥1:8 (n=41, 63, 61) | 14.3 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 30, ≥1:8 (n=40, 63, 60) | 98.4 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 30, ≥1:4 (n=40, 63, 60) | 100.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 0, ≥1:4 (n=41, 63, 61) | 76.2 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 30, ≥1:4 (n=40, 63, 60) | 100.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 0, ≥1:8 (n=41, 63, 61) | 46.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 30, ≥1:8 (n=40, 63, 60) | 98.4 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 30, ≥1:4 (n=40, 62, 59) | 100.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 30, ≥1:8 (n=40, 62, 59) | 100.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 0, ≥1:4 (n=41, 63, 61) | 20.6 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 0, ≥1:4 (n=41, 63, 61) | 49.2 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 30, ≥1:4 (n=40, 63, 60) | 81.7 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 0, ≥1:8 (n=41, 63, 61) | 4.9 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 0, ≥1:4 (n=41, 63, 61) | 14.8 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 30, ≥1:4 (n=40, 62, 59) | 93.2 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 30, ≥1:4 (n=41, 63, 59) | 59.3 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 30, ≥1:8 (n=40, 63, 60) | 73.3 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 0, ≥1:4 (n=41, 63, 61) | 50.8 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 30, ≥1:8 (n=41, 63, 59) | 54.2 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 30, ≥1:8 (n=40, 63, 60) | 75.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup C; Day 0, ≥1:4 (n=41, 63, 61) | 9.8 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 0, ≥1:4 (n=41, 63, 61) | 6.6 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 0, ≥1:8 (n=41, 63, 61) | 8.2 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 0, ≥1:8 (n=41, 63, 61) | 18.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup Y; Day 0, ≥1:8 (n=41, 63, 61) | 3.3 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup A; Day 30, ≥1:8 (n=40, 62, 59) | 84.8 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Serogroup W-135; Day 30, ≥1:4 (n=40, 63, 60) | 83.3 Percentage of participants |
Other Pre-specified
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Population: Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup C; Day 0 (N=41, 63, 61) | 4.4 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup A; Day 0 (N=41, 63, 61) | 6.2 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup C; Day 30 (N=41, 63, 59) | 606.3 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup W-135; Day 30 (N=40, 63, 60) | 332.0 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup A; Day 30 (N=40, 62, 59) | 200.9 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup Y; Day 0 (N=41, 63, 61) | 3.0 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup W-135; Day 0 (n=41, 63, 61) | 4.1 Titers (1/dilutions) |
| One-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup Y; Day 30 (N=40, 63, 60) | 530.1 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup A; Day 30 (N=40, 62, 59) | 234.1 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup Y; Day 30 (N=40, 63, 60) | 264.6 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup A; Day 0 (N=41, 63, 61) | 7.4 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup W-135; Day 0 (n=41, 63, 61) | 3.7 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup W-135; Day 30 (N=40, 63, 60) | 256.0 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup C; Day 0 (N=41, 63, 61) | 2.9 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup C; Day 30 (N=41, 63, 59) | 397.5 Titers (1/dilutions) |
| Two-Dose Menactra Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup Y; Day 0 (N=41, 63, 61) | 3.1 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup W-135; Day 30 (N=40, 63, 60) | 14.9 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup A; Day 0 (N=41, 63, 61) | 3.5 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup A; Day 30 (N=40, 62, 59) | 15.6 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup C; Day 0 (N=41, 63, 61) | 2.2 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup C; Day 30 (N=41, 63, 59) | 9.5 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup Y; Day 0 (N=41, 63, 61) | 2.1 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup Y; Day 30 (N=40, 63, 60) | 13.5 Titers (1/dilutions) |
| Menactra-naïve Group | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Serogroup W-135; Day 0 (n=41, 63, 61) | 2.5 Titers (1/dilutions) |
Other Pre-specified
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) -\>39.0˚C (\>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - \>3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Arthralgia (N=47, 66, 65) | 2.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Anorexia (N=47, 66, 65) | 0.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Headache (N=47, 66, 65) | 8.5 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Erythema (N=47, 66, 65) | 6.4 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Anorexia (n=47, 66, 65) | 4.3 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Headache (N=47, 66, 65) | 2.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Diarrhea (N=47, 66, 65) | 0.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Drowsiness (N=47, 66, 65) | 0.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Vomiting (N=47, 66, 65) | 6.4 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Arthralgia (n=47, 66, 65) | 8.5 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Drowsiness (N=47, 66, 65) | 19.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Vomiting (n=47, 66, 65) | 0.0 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Swelling (N=47, 66, 65) | 19.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Diarrhea (N=47, 66, 65) | 8.5 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Irritability (N=47, 66, 65) | 2.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Swelling (N=47, 66, 65) | 8.5 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Erythema (N=47, 66, 65) | 23.4 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Pain (N=47, 66, 65) | 55.3 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Fever (N=47, 66, 65) | 12.8 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Pain (N=47, 66, 65) | 2.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Irritability (N=47, 66, 65) | 19.1 Percentage of participants |
| One-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Fever (N=47, 66, 65) | 0.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Irritability (N=47, 66, 65) | 30.3 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Pain (N=47, 66, 65) | 65.2 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Pain (N=47, 66, 65) | 1.5 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Erythema (N=47, 66, 65) | 39.4 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Erythema (N=47, 66, 65) | 6.1 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Swelling (N=47, 66, 65) | 30.3 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Swelling (N=47, 66, 65) | 3.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Fever (N=47, 66, 65) | 6.1 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Fever (N=47, 66, 65) | 0.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Headache (N=47, 66, 65) | 10.6 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Headache (N=47, 66, 65) | 0.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Vomiting (N=47, 66, 65) | 1.5 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Vomiting (n=47, 66, 65) | 1.5 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Drowsiness (N=47, 66, 65) | 24.2 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Drowsiness (N=47, 66, 65) | 0.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Anorexia (n=47, 66, 65) | 12.1 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Anorexia (N=47, 66, 65) | 0.0 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Irritability (N=47, 66, 65) | 1.5 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Arthralgia (n=47, 66, 65) | 13.6 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Arthralgia (N=47, 66, 65) | 1.5 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Diarrhea (N=47, 66, 65) | 10.6 Percentage of participants |
| Two-Dose Menactra Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Diarrhea (N=47, 66, 65) | 0.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Anorexia (n=47, 66, 65) | 18.5 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Fever (N=47, 66, 65) | 0.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Pain (N=47, 66, 65) | 0.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Anorexia (N=47, 66, 65) | 1.5 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Fever (N=47, 66, 65) | 4.6 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Swelling (N=47, 66, 65) | 12.3 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Irritability (N=47, 66, 65) | 33.8 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Swelling (N=47, 66, 65) | 32.3 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Diarrhea (N=47, 66, 65) | 0.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Irritability (N=47, 66, 65) | 4.6 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Erythema (N=47, 66, 65) | 15.4 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Diarrhea (N=47, 66, 65) | 9.2 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Arthralgia (n=47, 66, 65) | 16.9 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Vomiting (n=47, 66, 65) | 1.5 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Vomiting (N=47, 66, 65) | 3.1 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Erythema (N=47, 66, 65) | 38.5 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Drowsiness (N=47, 66, 65) | 10.8 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Headache (N=47, 66, 65) | 0.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Pain (N=47, 66, 65) | 63.1 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Drowsiness (N=47, 66, 65) | 0.0 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Headache (N=47, 66, 65) | 6.2 Percentage of participants |
| Menactra-naïve Group | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Arthralgia (N=47, 66, 65) | 0.0 Percentage of participants |