Meningitis, Meningococcal Disease
Conditions
Keywords
Meningitis, Meningococcal disease, Menactra vaccine
Brief summary
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
Interventions
BIOLOGICALNone administered in this study
N/A in this study
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Receipt of Menactra vaccine during the study period.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Day 0 up to Day 30 post-vaccination | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Day 0 up to 6 months post-vaccination | Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. |
Countries
United States
Participant flow
Recruitment details
Study participant accrual occurred from 18 October 2007 through 17 October 2010. Kaiser Permanente databases were reviewed for this study.
Pre-assignment details
Medical utilization databases were reviewed for children 2 through 10 years of age receiving Menactra vaccine within Kaiser Permanente to identify the following medical care events during the 6 months after Menactra vaccination: all outcomes from hospitalizations and emergency department visits and selected outcomes from clinic visits.
Participants by arm
| Arm | Count |
|---|---|
| Menactra Vaccine Recipients Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice. | 1,421 |
| Total | 1,421 |
Baseline characteristics
| Characteristic | Menactra Vaccine Recipients |
|---|---|
| Age, Categorical <=18 years | 1421 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8.36 Years STANDARD_DEVIATION 2.55 |
| Indication for Vaccination Asplenia (Surgical or Congenital) | 17 Participants |
| Indication for Vaccination Complement Deficiency | 2 Participants |
| Indication for Vaccination Hereditary Elliptocytosis | 1 Participants |
| Indication for Vaccination Hereditary Spherocytosis | 8 Participants |
| Indication for Vaccination Human Immunodeficiency Virus Infection | 1 Participants |
| Indication for Vaccination Not Available | 987 Participants |
| Indication for Vaccination Other Hemoglobinopathy | 9 Participants |
| Indication for Vaccination Sickle Cell Disease | 44 Participants |
| Indication for Vaccination Thalassemias | 22 Participants |
| Indication for Vaccination Travel-Related | 364 Participants |
| Region of Enrollment United States | 1421 participants |
| Seasonality December - February | 163 Participants |
| Seasonality June - August | 593 Participants |
| Seasonality March - May | 372 Participants |
| Seasonality September - November | 294 Participants |
| Sex: Female, Male Female | 709 Participants |
| Sex: Female, Male Male | 712 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,421 |
| serious Total, serious adverse events | 16 / 1,421 |
Outcome results
Primary
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Time frame: Day 0 up to Day 30 post-vaccination
Population: All persons who received Menactra vaccine during the study period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Recipients | Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Cellulitis and abscess (All ages combined; H) | 1.4 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Cellulitis and abscess (Subj.10 Yrs Old; H; n=870) | 2.3 Events per 1,000 person-months |
Primary
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Time frame: Day 31 up to Day 180 post-vaccination
Population: All persons who received Menactra vaccine during the study period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Recipients | Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Cellulitis and abscess (All ages combined; H) | 0.0 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Cellulitis and abscess (Subj.10 Yrs Old; H; n=870) | 0.0 Events per 1,000 person-months |
Other Pre-specified
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.
Time frame: Day 0 up to 6 months post-vaccination
Population: Only persons who received Menactra vaccine during the study period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Abdominal pain | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Aspergillosis | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Asthma | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Cellulitis and abscess | 1.41 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Cerebral palsy | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Congenital anomaly of ureter | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Congenital atresia | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Digestive congenital anomalies | 070 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Febrile illness | 2.81 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Feeding problem | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Hereditary spherocytosis | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Hydronephrosis | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Malignant neoplasm | 5.63 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Other non-traumatic joint disorders | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Pneumonia | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Psychiatric | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Pyogenic arthritis | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Respiratory infection, upper | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Sickle cell anemia | 5.63 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Small bowel obstruction | 0.70 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined | Trauma | 2.11 Events per 1,000 doses |