Meningitis, Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®
Brief summary
The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675). Objective: * To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77
Detailed description
All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be administered in this trial
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥ 18 years on the day of inclusion * Received booster dose of Menactra vaccine in trial MTA77 * Informed consent form has been signed and dated * Able to attend the scheduled visit and to comply with all trial procedures.
Exclusion criteria
* Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77 * 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 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically * Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture 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 abuse or drug addiction * Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.) * Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, 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 trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Pre-booster vaccination, 28 days, and 4 years post-booster vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. |
| Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Pre-booster vaccination, 28 days and 4 years post-booster vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. |
| Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Pre-booster, 28 Days and 4 years post-booster vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 15 December 2015 to 28 December 2015 at 4 clinic sites in the United States.
Pre-assignment details
A total of 110 participants who met all inclusion and none of the exclusion criteria were enrolled; 109 participants completed the trial.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects; Menactra Vaccine Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Subjects; Menactra Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| Age, Continuous | 22.2 Years STANDARD_DEVIATION 3.54 |
| Region of Enrollment United States | 110 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Time frame: Pre-booster, 28 Days and 4 years post-booster vaccination
Population: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup A; Pre-booster (N=108) | 9.33 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup A; 28 days post-booster (N=109) | 460 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup A; 4 years post-booster (N=109) | 57.8 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup C; Pre-booster (N=108) | 11.2 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup C; 28 days post-booster (N=109) | 1224 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup C; 4 years post-booster (N=109) | 54.6 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup Y; Pre-booster (N=108) | 7.50 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup Y; 28 days post-booster (N=109) | 1650 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup Y; 4 years post-booster (N=109) | 120 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup W-135; Pre-booster (N=108) | 13.4 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup W-135; 28 days post-booster (N=109) | 1170 Titers (1/dilution) |
| All Subjects; Menactra Vaccine | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup W-135; 4 years post-booster (N=109) | 93.1 Titers (1/dilution) |
Primary
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Time frame: Pre-booster vaccination, 28 days, and 4 years post-booster vaccination
Population: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup A; Pre-booster (N=108) | 88.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup A; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup A; 4 years post-booster (N=109) | 98.2 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup C; Pre-booster (N=108) | 67.6 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup C; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup C; 4 years post-booster (N=109) | 89.9 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup Y; Pre-booster (N=108) | 57.4 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup Y; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup Y; 4 years post-booster (N=109) | 98.2 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup W-135; Pre-booster (N=108) | 83.3 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup W-135; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Serogroup W-135; 4 years post-booster (N=109) | 97.2 Percentage of participants |
Primary
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Time frame: Pre-booster vaccination, 28 days and 4 years post-booster vaccination
Population: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup A; Pre-booster (N=108) | 67.6 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup A; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup A; 4 years post-booster (N=109) | 94.5 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup C; Pre-booster (N=108) | 53.7 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup C; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup C; 4 years post-booster (N=109) | 81.7 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup Y; Pre-booster (N=108) | 46.3 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup Y; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup Y; 4 years post-booster (N=109) | 97.2 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup W-135; Pre-booster (N=108) | 72.2 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup W-135; 28 days post-booster (N=109) | 100.0 Percentage of participants |
| All Subjects; Menactra Vaccine | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Serogroup W-135; 4 years post-booster (N=109) | 95.4 Percentage of participants |