Meningitis, Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Menomune®, Meningococcal vaccine
Brief summary
The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: * To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination. * To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago. * To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.
Detailed description
Participants who were randomized and received either Menactra® or Menomune® vaccine in trial MTA29 will receive 1 dose of either Menactra® or Menomune®, respectively on Day 0 and will be followed-up for 28 days post-vaccination.
Interventions
BIOLOGICALMenomune®: A, C, Y, W 135 Meningococcal Polysaccharide
0.5 mL, Subcutaneous
BIOLOGICALMenactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 56 years or older on the day of inclusion. * Received the appropriate Menactra or Menomune vaccine as assigned by randomization in Trial MTA29. * Ambulatory and healthy, as determined by medical history. * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
Exclusion criteria
* 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. * Known pregnancy, or a positive pregnancy test. * Currently breastfeeding a child. * History of documented invasive meningococcal disease. * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination. * Planned participation in another clinical trial during the present trial period. * Receipt of any meningococcal vaccine since participation in trial MTA29. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before trial vaccination. * Planned receipt of any vaccine in the 4 weeks following the trial vaccination. * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C. * Previous personal history of Guillain-Barré Syndrome (GBS). * Known systemic hypersensitivity to any of the vaccine components, latex, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Laboratory-confirmed thrombocytopenia, contraindicating intramuscular (IM) vaccination. * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * 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. * Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Day 0 to Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Day 0 (pre-vaccination) and Day 28 post-vaccination | Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC). |
| Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Day 0 (pre-vaccination) and Day 28 post-vaccination | Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC). |
| Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC). |
| Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR). |
| Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR). |
| Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Day 0 (pre-vaccination) and Day 28 post-vaccination | Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR). |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 08 November 2010 to 16 December 2010 at 6 US clinical centers.
Pre-assignment details
A total of 139 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Menomune® Vaccine Group All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial. | 36 |
| Menactra® Vaccine Group All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial. | 103 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | Menactra® Vaccine Group | Menomune® Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 75 Participants | 28 Participants | 103 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 8 Participants | 36 Participants |
| Age Continuous | 71.1 Years STANDARD_DEVIATION 6.8 | 71.8 Years STANDARD_DEVIATION 7.2 | 71.3 Years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 103 Participants | 36 Participants | 139 Participants |
| Sex: Female, Male Female | 57 Participants | 20 Participants | 77 Participants |
| Sex: Female, Male Male | 46 Participants | 16 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 36 | 33 / 103 |
| serious Total, serious adverse events | 0 / 36 | 0 / 103 |
Outcome results
Primary
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.
Time frame: Day 0 to Day 7 post-vaccination
Population: Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Fever | 0 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Headache | 1 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Malaise | 3 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Pain | 8 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Pain | 0 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Erythema | 9 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Erythema | 0 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Swelling | 1 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Swelling | 0 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Fever | 0 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Headache | 8 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Malaise | 0 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Myalgia | 6 Participants |
| Menomune® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Myalgia | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Malaise | 8 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Fever | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Headache | 16 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Swelling | 2 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Headache | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Myalgia | 22 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Swelling | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Pain | 33 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Malaise | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Pain | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Fever | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Any Erythema | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Myalgia | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine | Grade 3 Erythema | 0 Participants |
Other Pre-specified
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Post-vaccination (N = 32, 99) | 14.4 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Post-vaccination (N = 31, 99) | 15.6 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Pre-vaccination (N = 32, 99) | 7.2 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Pre-vaccination (N = 32, 99) | 7.2 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Post-vaccination (N = 31, 99) | 11.4 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Pre-vaccination (N = 32, 99) | 9.9 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Pre-vaccination (N = 32, 99) | 4.1 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Post-vaccination (N = 31, 99) | 6.4 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Post-vaccination (N = 31, 99) | 80.1 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Pre-vaccination (N = 32, 99) | 10.1 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Post-vaccination (N = 31, 99) | 87.1 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Pre-vaccination (N = 32, 99) | 6.6 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Post-vaccination (N = 32, 99) | 93.4 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Pre-vaccination (N = 32, 99) | 6.2 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Post-vaccination (N = 31, 99) | 96.1 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Pre-vaccination (N = 32, 99) | 7.6 Titers |
Other Pre-specified
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup A Pre-vaccination (N = 32, 99) | 22.1 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup A Post -vccination (N = 31, 98) | 119.7 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup C Pre-vaccination (N = 32, 99) | 39.7 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup C Post-vaccination (N = 31, 98) | 109.5 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup Y Pre-vaccination (N = 32, 99) | 71.3 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup Y Post-vaccination (N = 31, 99) | 200.2 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup W-135 Pre-vaccination (N = 32, 99) | 74.5 Titers |
| Menomune® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup W-135 Post-vaccination (N = 31, 98) | 214.1 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup W-135 Post-vaccination (N = 31, 98) | 534.2 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup A Pre-vaccination (N = 32, 99) | 20.2 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup Y Pre-vaccination (N = 32, 99) | 70.6 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup A Post -vccination (N = 31, 98) | 396.9 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup W-135 Pre-vaccination (N = 32, 99) | 79 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup C Pre-vaccination (N = 32, 99) | 35 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup Y Post-vaccination (N = 31, 99) | 556.9 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR) | Serogroup C Post-vaccination (N = 31, 98) | 698.9 Titers |
Other Pre-specified
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup A (N = 31, 98) | 12 Participants |
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup C (N = 31, 98) | 10 Participants |
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y (N = 31, 99) | 17 Participants |
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 (N = 31, 98) | 13 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 (N = 31, 98) | 67 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup A (N = 31, 98) | 69 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y (N = 31, 99) | 60 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine | Serogroup C (N = 31, 98) | 78 Participants |
Other Pre-specified
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A (N = 31, 99) | 8 Participants |
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C (N = 32, 99) | 5 Participants |
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y (N = 31, 99) | 4 Participants |
| Menomune® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 (N = 31, 99) | 2 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 (N = 31, 99) | 73 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A (N = 31, 99) | 70 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y (N = 31, 99) | 75 Participants |
| Menactra® Vaccine Group | Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C (N = 32, 99) | 77 Participants |
Other Pre-specified
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Pre-vaccination (N = 32, 99) | 12 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Post-vaccination (N = 31, 98) | 21 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Pre-vaccination (N = 32, 99) | 17 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Post-vaccination (N = 31, 98) | 20 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Pre-vaccination (N = 32, 99) | 26 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Post-vaccination (N = 31, 99) | 29 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Pre-vaccination (N = 32, 99) | 25 Participants |
| Menomune® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Post-vaccination (N = 31, 98) | 27 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Post-vaccination (N = 31, 98) | 91 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Pre-vaccination (N = 32, 99) | 35 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Pre-vaccination (N = 32, 99) | 75 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup A Post-vaccination (N = 31, 98) | 87 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup W-135 Pre-vaccination (N = 32, 99) | 75 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Pre-vaccination (N = 32, 99) | 53 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup Y Post-vaccination (N = 31, 99) | 94 Participants |
| Menactra® Vaccine Group | Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine | Serogroup C Post-vaccination (N = 31, 98) | 91 Participants |
Other Pre-specified
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y ≥ 1:4 Pre-vaccination (N = 32, 99) | 15 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥1:4 Pre-vaccination (N = 32, 99) | 20 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y ≥ 1:8 Pre-vaccination (N = 32, 99) | 14 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:8 Post-vaccination (N = 31, 99) | 24 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y ≥1:4 Post-vaccination (N = 31, 99) | 19 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥ 1:8 Pre-vaccination (N = 32, 99) | 17 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y≥1:8 Post -vaccination (N = 31, 99) | 18 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:8 Pre-vaccination (N = 32, 99) | 14 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:4 Pre-vaccination (N = 32, 99) | 15 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥1:4 Post-vaccination (N = 32, 99) | 24 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:8 Pre-vaccination (N = 32, 99) | 12 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:4 Pre-vaccination (N = 32, 99) | 23 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:4 Post-accination (N = 31, 99) | 25 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥ 1:8 Post-vaccination (N = 32, 99) | 18 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:8 Post-vaccination (N = 31, 99) | 14 Participants |
| Menomune® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:4 Post-vaccination (N = 31, 99) | 28 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:8 Post-vaccination (N = 31, 99) | 92 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥1:4 Pre-vaccination (N = 32, 99) | 55 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:4 Pre-vaccination (N = 32, 99) | 79 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:8 Pre-vaccination (N = 32, 99) | 57 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:4 Post-vaccination (N = 31, 99) | 97 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥ 1:8 Pre-vaccination (N = 32, 99) | 41 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥1:4 Post-vaccination (N = 32, 99) | 95 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup C ≥ 1:8 Post-vaccination (N = 32, 99) | 90 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y ≥ 1:4 Pre-vaccination (N = 32, 99) | 43 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y ≥ 1:8 Pre-vaccination (N = 32, 99) | 34 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y ≥1:4 Post-vaccination (N = 31, 99) | 89 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup Y≥1:8 Post -vaccination (N = 31, 99) | 87 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:4 Pre-vaccination (N = 32, 99) | 59 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:8 Pre-vaccination (N = 32, 99) | 44 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup W-135 ≥1:4 Post-accination (N = 31, 99) | 95 Participants |
| Menactra® Vaccine Group | Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine. | Serogroup A ≥ 1:8 Post-vaccination (N = 31, 99) | 92 Participants |