Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis, Meningococcal infection, Neisseria meningitidis, Menactra®, Menomune®
Brief summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.
Interventions
BIOLOGICALPolysaccharide Diphtheria Conjugate Vaccine
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
7 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is healthy, as determined by medical history. * Subject is between the ages of 7 and 15 years (not yet 16 years). * For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. * The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23. * A negative urine pregnancy test is required for menstruating female subjects. * Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
Exclusion criteria
* Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study) * History of documented invasive meningococcal disease * Received any other meningococcal vaccine * Received any vaccine in the 28-day period prior to enrollment * Received antibiotic therapy within the 72 hours prior to collection of a blood sample * Actively enrolled or scheduled to be enrolled in another clinical study * Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) * Known or suspected impairment of immunologic function * Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion * Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment * Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) 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. * Personal of family history of Guillain-Barres Syndrome * 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 * Any condition which, in the opinion of the investigator, would pose a health risk to the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | 7 or 14 days post-vaccination | Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.
Pre-assignment details
A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Group 1 Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination | 59 |
| Menactra® Group 2 Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination | 58 |
| Meningococcal Vaccine-naïve Group 3 Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. | 58 |
| Meningococcal Vaccine-naïve Group 4 Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination | 59 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 |
| Overall Study | Non-compliance | 2 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Menactra® Group 2 | Meningococcal Vaccine-naïve Group 3 | Menactra® Group 1 | Meningococcal Vaccine-naïve Group 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 58 Participants | 58 Participants | 59 Participants | 59 Participants | 234 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.6 years STANDARD_DEVIATION 2.6 | 11.7 years STANDARD_DEVIATION 2.27 | 9.9 years STANDARD_DEVIATION 2.56 | 11.9 years STANDARD_DEVIATION 2.06 | 11.0 years STANDARD_DEVIATION 2.51 |
| Region of Enrollment United States | 58 participants | 58 participants | 59 participants | 59 participants | 234 participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 26 Participants | 23 Participants | 96 Participants |
| Sex: Female, Male Male | 36 Participants | 33 Participants | 33 Participants | 36 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 58 | 20 / 58 | 14 / 58 | 15 / 59 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 | 0 / 58 | 0 / 59 |
Outcome results
Primary
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Time frame: 7 or 14 days post-vaccination
Population: Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - PRE | 84 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - POST | 100 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - PRE | 62 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - POST | 100 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - PRE | 96 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - POST | 100 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - PRE | 81 Percentage of participants |
| Menactra® Group 1 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - POST | 100 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - POST | 100 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - PRE | 96 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - POST | 100 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - POST | 100 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - PRE | 84 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - POST | 100 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - PRE | 58 Percentage of participants |
| Menactra® Group 2 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - PRE | 89 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - PRE | 31 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - PRE | 39 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - POST | 98 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - PRE | 87 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - POST | 100 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - POST | 100 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - PRE | 47 Percentage of participants |
| Meningococcal Vaccine-naïve Group 3 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - POST | 100 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - PRE | 47 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup C - POST | 96 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - POST | 100 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup A - PRE | 59 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - PRE | 98 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - POST | 98 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup W-135 - PRE | 36 Percentage of participants |
| Meningococcal Vaccine-naïve Group 4 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. | Meningococcal serogroup Y - POST | 100 Percentage of participants |