Meningitis, Meningococcemia
Conditions
Keywords
N. meningitidis, Meningitis, Meningococcemia
Brief summary
This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.
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
5 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
: * Healthy, as determined by medical history and physical examination. * Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive). * For the Booster Group , two doses of a quadrivalent (A, C, Y, W-135) meningococcal polysaccharide vaccine received before age 2 years * For the Control Group , no previous history of any meningococcal vaccination * Informed consent form signed by the parent(s) or other legal representative * Able to provide a vaccination log or has available vaccination record in the Health Center. * Able to attend all scheduled visits and to comply with all trial procedures
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 a oral temperature ≥ 37.5°C at the time of inclusion. * Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the trial vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment. * Oral or injected antibiotic therapy within the 72 hours prior to vaccination. * Received any vaccine in the 14-day period prior to trial vaccination, or scheduled to receive any vaccination during the 14-day period after trial vaccination. * Previous history of documented invasive meningococcal disease. * For the Control Group, previous history of any meningococcal vaccination. * Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances. * Participation in another clinical trial in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine. * Personal or family history of Guillain Barré syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination |
| Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Day 28 Post-vaccination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Days 0-7 Post-vaccination | Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia. |
Countries
Saudi Arabia
Participant flow
Recruitment details
Participants were enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.
Pre-assignment details
A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Menactra® Booster Group Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine. | 153 |
| Group 2: Menactra® Primary Vaccine (Control) Group Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine. | 85 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Group 2: Menactra® Primary Vaccine (Control) Group | Group 1: Menactra® Booster Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 85 Participants | 153 Participants | 238 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.52 Years STANDARD_DEVIATION 1.22 | 6.12 Years STANDARD_DEVIATION 0.6 | 6.26 Years STANDARD_DEVIATION 0.89 |
| Region of Enrollment Saudi Arabia | 85 participants | 153 participants | 238 participants |
| Sex: Female, Male Female | 47 Participants | 84 Participants | 131 Participants |
| Sex: Female, Male Male | 38 Participants | 69 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 151 | 15 / 85 |
| serious Total, serious adverse events | 1 / 151 | 0 / 85 |
Outcome results
Primary
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Time frame: Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination
Population: Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup A: Pre-vaccination | 168.9 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup A: Day 28 Post-vaccination | 6991.7 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup C: Pre-vaccination | 2.5 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup C: Day 28 Post-vaccination | 167.2 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup Y: Pre-vaccination | 10.2 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup Y: Day 28 Post-vaccination | 2120.2 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup W-135: Pre-vaccination | 3.0 Titers |
| Group 1: Menactra® Booster Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup W-135: Day 28 Post-vaccination | 2387.7 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup W-135: Day 28 Post-vaccination | 2763.2 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup A: Pre-vaccination | 196.4 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup Y: Pre-vaccination | 12.4 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup A: Day 28 Post-vaccination | 8263.3 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup W-135: Pre-vaccination | 2.7 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup C: Pre-vaccination | 4.1 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup Y: Day 28 Post-vaccination | 2558.3 Titers |
| Group 2: Menactra® Primary Vaccine (Control) Group | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. | Serogroup C: Day 28 Post-vaccination | 512.0 Titers |
Primary
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Time frame: Day 28 Post-vaccination
Population: 4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® Booster Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup A | 94 Percentage of Participants |
| Group 1: Menactra® Booster Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup C | 84 Percentage of Participants |
| Group 1: Menactra® Booster Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup Y | 97 Percentage of Participants |
| Group 1: Menactra® Booster Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup W-135 | 99 Percentage of Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup W-135 | 100 Percentage of Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup A | 94 Percentage of Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup Y | 98 Percentage of Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. | Serogroup C | 90 Percentage of Participants |
Other Pre-specified
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.
Time frame: Days 0-7 Post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Solicited Injection Site Reaction | 35 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Pain | 32 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Pain (Incapacitating) | 1 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Erythema | 10 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Swelling | 11 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Solicited Systemic Reaction | 36 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Fever | 16 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Fever (> 39.0 ºC) | 1 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Headache | 13 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Malaise | 18 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Myalgia | 21 Participants |
| Group 1: Menactra® Booster Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Solicited Injection Site Reaction | 19 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Fever | 8 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Pain | 15 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Malaise | 11 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Fever (> 39.0 ºC) | 2 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Erythema | 8 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Myalgia | 10 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Headache | 5 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Swelling | 8 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Primary Vaccine (Control) Group | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® | Any Solicited Systemic Reaction | 16 Participants |