Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis, Meningococcal Infection, Menactra®
Brief summary
The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age. Primary Objective: \- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago. Secondary Objective: \- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population. Observational Objective: \- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.
Detailed description
All participants will receive one dose of Menactra vaccine at their first clinic visit. There will be a telephone safety follow-up contact at six months post-vaccination.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Received Menactra 4 to 6 years prior to enrollment, at an age ≥11 years, and is \< 56 years of age on the day of enrollment. * Informed consent form has been signed and dated by the subject or by the subject and the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations). * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. Females who are pre-menarche or post-menopausal for at least 1 year, or surgically sterile will not be excluded. * Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * History of documented invasive meningococcal disease. * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study. * Suspected or known hypersensitivity to latex or to any of the components of Menactra vaccine, or history of a life-threatening reaction to Menactra vaccine or to a vaccine containing any of the same substances. * Receipt of any meningococcal vaccine since receipt of a single dose of Menactra vaccine 4-6 years prior to enrollment. * Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the Day 28 visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject. * Personal history of Guillain-Barré syndrome (GBS). * Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator. * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures. * Receipt of oral or injectable antibiotic therapy within the 72 hours prior to the first blood draw. * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Day 28 post-vaccination | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
| Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Day 6 and Day 28 post-vaccination | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
| Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
| Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Day 6 and Day 28 post-vaccination | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
| Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Day 0 up to Day 7 post-vaccination | Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - \>100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity. |
| Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 26 September 2011 through 21 December 2011 at 15 clinic centers in the United States.
Pre-assignment details
A total of 834 participants who met all of the inclusion and none of the exclusion criteria were randomized; 831 were vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Vaccine Group Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study. | 834 |
| Total | 834 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Menactra® Vaccine Group |
|---|---|
| Age, Categorical <=18 years | 592 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 242 Participants |
| Age, Continuous Age Continuous | 17.8 Years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 834 Participants |
| Sex: Female, Male Female | 434 Participants |
| Sex: Female, Male Male | 400 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 494 / 831 |
| serious Total, serious adverse events | 11 / 831 |
Outcome results
Primary
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)
Time frame: Day 28 post-vaccination
Population: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A | 776 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C | 778 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y | 779 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W-135 | 780 Participants |
Secondary
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time frame: Day 6 and Day 28 post-vaccination
Population: Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (Day 6 post-vaccination; N=112) | 30.5 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (Day 28 post-vaccination; N=781) | 47.2 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (Day 6 post-vaccination; N=112) | 64 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (Day 28 post-vaccination; N=781) | 128.3 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (Day 6 post-vaccination; N=112) | 121.1 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (Day 28 post-vaccination; N=781) | 209.1 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W-135 (Day 6 post-vaccination; N=112) | 45.5 Titers ratio |
| Menactra® Vaccine Group | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W-135 (Day 28 post-vaccination; N=781) | 92.4 Titers ratio |
Secondary
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time frame: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
Population: Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 0 pre-vaccination; N=781) | 8.9 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 6 post-vaccination; N=112) | 227.6 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 28 post-vaccination; N=781) | 421.2 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 0 pre-vaccination; N=781) | 8.8 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 6 post-vaccination; N=112) | 639.8 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 28 post-vaccination; N=781) | 1135 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 0 pre-vaccination; N=781) | 6.2 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 6 post-vaccination; N=112) | 655.8 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 28 post-vaccination; N=781) | 1303.6 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 0 pre-vaccination; N=781) | 13.8 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 6 post-vaccination; N=112) | 702 Titers |
| Menactra® Vaccine Group | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 28 post-vaccination; N=781) | 1271.6 Titers |
Secondary
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time frame: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
Population: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 0 pre-vaccination; N=781) | 675 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 6 post-vaccination; N=112) | 110 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 28 post-vaccination; N=781) | 781 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 0 pre-vaccination; N=781) | 443 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 6 post-vaccination; N=112) | 112 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 28 post-vaccination; N=781) | 780 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 0 pre-vaccination; N=781) | 389 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 6 post-vaccination; N=112) | 111 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 28 post-vaccination; N=781) | 780 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 0 pre-vaccination; N=781) | 604 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 6 post-vaccination; N=112) | 111 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 28 post-vaccination; N=781) | 780 Participants |
Secondary
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time frame: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
Population: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 0 pre-vaccination; N=781) | 504 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 6 post-vaccination; N=112) | 110 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A (Day 28 post-vaccination; N=781) | 776 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 0 pre-vaccination; N=781) | 345 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 6 post-vaccination; N=112) | 111 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C (Day 28 post-vaccination; N=781) | 778 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 0 pre-vaccination; N=781) | 302 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 6 post-vaccination; N=112) | 111 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y (Day 28 post-vaccination; N=781) | 779 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 0 pre-vaccination; N=781) | 535 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 6 post-vaccination; N=112) | 111 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135 (Day 28 post-vaccination; N=781) | 780 Participants |
Secondary
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time frame: Day 6 and Day 28 post-vaccination
Population: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (Day 28 post-vaccination; N=781) | 758 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (Day 6 post-vaccination; N=112) | 97 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (Day 28 post-vaccination; N=781) | 742 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (Day 6 post-vaccination; N=112) | 102 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (Day 28 post-vaccination; N=781) | 744 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (Day 6 post-vaccination; N=112) | 106 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W-135 (Day 6 post-vaccination; N=112) | 103 Participants |
| Menactra® Vaccine Group | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W-135 (Day 28 post-vaccination; N=781) | 750 Participants |
Secondary
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - \>100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.
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) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Pain (N=821) | 494 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Pain (N=821) | 20 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Erythema (N=821) | 10 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Erythema (N=821) | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Injection-site Swelling (N=821) | 14 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Injection-site Swelling (N=821) | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Fever (N=817) | 6 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Fever (N=817) | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Headache (N=822) | 317 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Headache (N=822) | 22 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Malaise (N=822) | 242 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Malaise (N=822) | 23 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Myalgia (N=822) | 352 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Myalgia (N=822) | 19 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Shivering (N=822) | 102 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Grade 3 Shivering (N=822) | 6 Participants |