Meningitis, Meningococcemia
Conditions
Keywords
Meningitis, Meningococcemia, Neisseria meningitidis
Brief summary
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02. Primary Objective: To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
Detailed description
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
: * Participant is healthy, as determined by medical history and physical examination. * Participant is at least 13 years of age but not yet 22 years of age at time of enrollment. * For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up). * For the Control group, participant has no previous history of any meningococcal vaccination. * If \< 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form. * If ≥ 18 years of age, participant has signed an IRB-approved informed consent form. * Able to provide vaccination log.
Exclusion criteria
: * Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc). * Known or suspected impairment of immunologic function. * Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion. * For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial. * For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination. * Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn. * Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination. * Suspected or known hypersensitivity to any of the vaccine components. * Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures. * In females, a positive or equivocal urine pregnancy test at the time of vaccination. * Enrolled in another clinical trial. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Day 0 and 8 and 28 days post-vaccination | Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.
Pre-assignment details
A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Group Subjects that received Menactra® vaccine in Study MTA02 | 76 |
| Menomune® Group Subjects that received Menomune® vaccine in Study MTA02 | 77 |
| Control Group Meningococcal vaccine-naïve subjects | 88 |
| Total | 241 |
Baseline characteristics
| Characteristic | Menomune® Group | Control Group | Menactra® Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 68 Participants | 56 Participants | 181 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 16.8 years STANDARD_DEVIATION 1.85 | 15.7 years STANDARD_DEVIATION 1.97 | 16.6 years STANDARD_DEVIATION 1.91 | 16.4 years STANDARD_DEVIATION 1.97 |
| Region of Enrollment United States | 77 participants | 88 participants | 76 participants | 241 participants |
| Sex: Female, Male Female | 31 Participants | 44 Participants | 30 Participants | 105 Participants |
| Sex: Female, Male Male | 46 Participants | 44 Participants | 46 Participants | 136 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 | 7 / 76 | 5 / 77 | 9 / 88 |
| serious Total, serious adverse events | 0 / 76 | 0 / 77 | 0 / 88 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
Time frame: Day 0 and 8 and 28 days post-vaccination
Population: GMT results were on the per-protocol population for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 0) | 1075.2 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 8) | 9300.5 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 28) | 4300.9 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 0) | 246.2 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 8) | 17888.7 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 28) | 8601.8 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 0) | 570.0 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 8) | 13088.9 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 28) | 5821.0 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 0) | 451.0 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 8) | 9861.6 Titer |
| Menactra® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 28) | 4882.9 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 28) | 1625.5 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 0) | 193.6 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 0) | 398.6 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 28) | 2489.6 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 8) | 4423.9 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 28) | 664.0 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 8) | 2008.9 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 28) | 3219.9 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 8) | 3098.2 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 8) | 1149.4 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 0) | 124.4 Titer |
| Menomune® Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 0) | 126.8 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 0) | 39.7 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 8) | 7003.3 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 0) | 23.0 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup C (Day 28) | 2802.3 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 0) | 204.3 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 8) | 7061.3 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 8) | 6036.6 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 0) | 83.3 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 8) | 12897.1 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup Y (Day 28) | 4411.8 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup A (Day 28) | 6239.2 Titer |
| Control Group | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Serogroup W-135 (Day 28) | 3018.3 Titer |