Meningococcal Infections, Meningitis
Conditions
Keywords
Menactra®, Menomune®, Meningitis, Meningococcal Infections
Brief summary
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Detailed description
Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation. No vaccine will be administered in this study.
Interventions
BIOLOGICALMenactra®
0.5 mL, Intramuscular (from a previous study)
BIOLOGICALMenomune®
0.5 mL, Intramuscular (from a previous study)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 27 Years
Healthy volunteers
Yes
Inclusion criteria
: * For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject * For subjects aged \< 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian * Subject (and parent/legal guardian if subject is \< 18 years of age) able to attend the scheduled visit and comply with all trial procedures * For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21) * For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04) * For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine
Exclusion criteria
: * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion * 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 \> 2 weeks * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses * Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity * History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically) * For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21 * Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Day 0 |
| Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Day 0 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 16 December 2008 to 16 March 2009 in 21 medical centers in the US.
Pre-assignment details
A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Menactra® From Previous Studies Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 | 561 |
| Group 2: Menomune® From Previous Study Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04 | 96 |
| Group 3: Control Meningococcal vaccine-naive, age-matched participants | 105 |
| Total | 762 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 2 | 5 |
Baseline characteristics
| Characteristic | Group 2: Menomune® From Previous Study | Group 3: Control | Group 1: Menactra® From Previous Studies | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 57 Participants | 205 Participants | 262 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 48 Participants | 356 Participants | 500 Participants |
| Age, Continuous | 23.3 Years STANDARD_DEVIATION 2.17 | 19.3 Years STANDARD_DEVIATION 3.98 | 19.1 Years STANDARD_DEVIATION 2.87 | 19.7 Years STANDARD_DEVIATION 3.27 |
| Region of Enrollment United States | 96 participants | 105 participants | 561 participants | 762 participants |
| Sex: Female, Male Female | 49 Participants | 64 Participants | 264 Participants | 377 Participants |
| Sex: Female, Male Male | 47 Participants | 41 Participants | 297 Participants | 385 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 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Time frame: Day 0
Population: Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Menactra® From Previous Studies | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup Y [n=558, 93, 99] | 369 Titers |
| Group 1: Menactra® From Previous Studies | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup A [n = 557, 93, 99] | 74.0 Titers |
| Group 1: Menactra® From Previous Studies | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup W-135 [n = 556, 92, 99] | 246 Titers |
| Group 1: Menactra® From Previous Studies | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup C [n = 557, 92, 99] | 24.9 Titers |
| Group 2: Menomune® From Previous Study | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup Y [n=558, 93, 99] | 183 Titers |
| Group 2: Menomune® From Previous Study | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup C [n = 557, 92, 99] | 16.9 Titers |
| Group 2: Menomune® From Previous Study | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup A [n = 557, 93, 99] | 19.1 Titers |
| Group 2: Menomune® From Previous Study | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup W-135 [n = 556, 92, 99] | 59.4 Titers |
| Group 3: Control | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup C [n = 557, 92, 99] | 8.58 Titers |
| Group 3: Control | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup A [n = 557, 93, 99] | 11.0 Titers |
| Group 3: Control | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup W-135 [n = 556, 92, 99] | 38.7 Titers |
| Group 3: Control | Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment | Serogroup Y [n=558, 93, 99] | 84.1 Titers |
Primary
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Time frame: Day 0
Population: Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup A ≥ 8, [n = 557, 93, 99] | 53 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup A ≥ 128, [n = 557, 93, 99] | 50 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup C ≥ 8 [n = 557, 92, 99] | 39 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup C ≥ 128 [n = 557, 92, 99] | 31 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup Y ≥ 8 [n = 558, 93, 99] | 91 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup Y ≥ 128 [n = 558, 93, 99] | 85 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup W-135 ≥ 8 [n = 556, 92, 99] | 84 Percentage of Participants |
| Group 1: Menactra® From Previous Studies | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup W-135 ≥128 [n = 556, 92, 99] | 77 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup C ≥ 8 [n = 557, 92, 99] | 28 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup W-135 ≥ 8 [n = 556, 92, 99] | 64 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup C ≥ 128 [n = 557, 92, 99] | 22 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup Y ≥ 8 [n = 558, 93, 99] | 83 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup Y ≥ 128 [n = 558, 93, 99] | 77 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup A ≥ 8, [n = 557, 93, 99] | 34 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup A ≥ 128, [n = 557, 93, 99] | 29 Percentage of Participants |
| Group 2: Menomune® From Previous Study | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup W-135 ≥128 [n = 556, 92, 99] | 55 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup C ≥ 8 [n = 557, 92, 99] | 16 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup A ≥ 128, [n = 557, 93, 99] | 17 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup A ≥ 8, [n = 557, 93, 99] | 20 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup C ≥ 128 [n = 557, 92, 99] | 12 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup W-135 ≥ 8 [n = 556, 92, 99] | 50 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup Y ≥ 128 [n = 558, 93, 99] | 62 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup Y ≥ 8 [n = 558, 93, 99] | 72 Percentage of Participants |
| Group 3: Control | Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment | Serogroup W-135 ≥128 [n = 556, 92, 99] | 47 Percentage of Participants |