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 Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Day 0 up to Day 60 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 30-day comparison window. Individuals receiving Menactra vaccine 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. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Day 0 up to Day 60 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 for each 30-day comparison window. Individuals receiving Menactra vaccine 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. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. |
| Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Day 0 up to Day 180 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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room. |
| Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Day 0 up to Day 180 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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. |
| Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Day 0 up to Day 180 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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. |
| Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - 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. |
| Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - 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. |
| Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Day 0 up to Determination of Pregnancy Outcome | Only persons who received Menactra vaccine during the study period were included in this outcome. |
| Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Day 0 up to Day 180 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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. |
Countries
United States
Participant flow
Recruitment details
Study participant accrual occurred from 15 July 2005 through 14 April 2006.
Pre-assignment details
Databases were reviewed to identify persons who received Menactra vaccine within Kaiser Permanente and to identify all medical care events for the 6-month period following vaccination or, if applicable, through the end of pregnancy. Subjects served as their own control for 0-30 days surveillance, age-matched control served for the 6-month period.
Participants by arm
| Arm | Count |
|---|---|
| Menactra Vaccine Recipients Kaiser Permanente members who received Menactra vaccine during the study period.
Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study. | 31,561 |
| Control Group Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.
Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study. | 31,065 |
| Total | 62,626 |
Baseline characteristics
| Characteristic | Menactra Vaccine Recipients | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 26805 Participants | 26383 Participants | 53188 Participants |
| Age, Categorical >=65 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 4732 Participants | 4658 Participants | 9390 Participants |
| Age, Continuous | 15.6 Years STANDARD_DEVIATION 5.56 | 15.65 Years STANDARD_DEVIATION 5.56 | 15.6 Years STANDARD_DEVIATION 5.56 |
| Gender Female | 15722 Participants | 15369 Participants | 31091 Participants |
| Gender Male | 15836 Participants | 15696 Participants | 31532 Participants |
| Region of Enrollment United States | 31561 participants | 31065 participants | 62626 participants |
| Seasonality December - February | 4689 Participants | 4671 Participants | 9360 Participants |
| Seasonality June - August | 17577 Participants | 17080 Participants | 34657 Participants |
| Seasonality March - May | 3605 Participants | 3602 Participants | 7207 Participants |
| Seasonality September - November | 5739 Participants | 5712 Participants | 11451 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31,558 |
| serious Total, serious adverse events | 273 / 31,561 |
Outcome results
Primary
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
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 30-day comparison window. Individuals receiving Menactra vaccine 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. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Time frame: Day 0 up to Day 60 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 Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Febrile illness (ER) | 0.38 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Suicidal Ideation/Attempt (ER) | 0.19 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Abdominal pain (ER) | 0.98 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Febrile illness (ER) | 0.03 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Abdominal pain (ER) | 0.52 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Suicidal Ideation/Attempt (ER) | 0.00 Events per 1,000 person-months |
Other Pre-specified
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - 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 - Hospital Setting - All Ages Combined | Elective procedure | 0.22 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Encephalitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Encephalitis due to Epstein-Barr virus | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Scoliosis | 0.19 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Sickle cell disease | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Sleep apnea | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Toxic shock syndrome | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Transplant rejection | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Trauma | 1.20 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Abdominal pain | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Abscess/Cellulitis | 0.38 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Acute renal failure | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Appendicitis | 0.57 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Arrhythmia | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Aseptic meningitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Asphyxiation | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Asthma/Reactive airway disease | 0.16 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Benign lesion | 0.16 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | COPD | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cancer, Cervix | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cancer, Melanoma | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cancer, Ovarian | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cancer, Pancreatic | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cancer, Rule out cancer | 0.16 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cholelithiasis | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Chronic inflammatory demyelinating polyneuritis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Complications of transplanted organ | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Congenital anomaly | 0.38 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Congenital heart disease | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Constipation | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cranial nerve palsy | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Cyst | 0.13 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Dehydration | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Delirium tremens | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Dental | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Diabetes type I (Diagnosed after vaccination) | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Diabetes type I (Diagnosed before vaccination) | 0.13 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Diarrhea | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | End-stage renal disease | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Epilepsy (Hx of seizure disorder possible seizure) | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Epilepsy (Seizure event, w/hx of seizure disorder) | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Fatty liver | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Febrile illness | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Femoral epiphysiolysis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Foreign body | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Gastroesophageal reflux | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Gastroenteritis | 0.19 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Hodgkin's disease | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Horner's syndrome | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Hydrocephalus | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Hypertension | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | ITP (Diagnosed before vaccination) | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Idiopathic polycystic splenomegaly | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Inguinal hernia/repair | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Kyphosis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Labyrinthitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Lymphocytic leukemia (Chronic, diagnosed before) | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Migraine | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Osteomyelitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pancreatitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pectus excavatum | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pelvic inflammatory disease | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pharyngitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pneumocystosis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pneumonia | 0.13 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pneumothorax | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Poisoning/ingestion | 0.06 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pregnancy | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Pregnancy - Stillborn delivery post prolapsed cord | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Psychiatric | 1.93 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Plumonary embolism | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Respiratory syncytial virus infection | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Renal calculus | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Splenomegaly | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Suicidal ideation/attempt | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Syncope/Loss of consciousness | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | SLE (Diagnosed after vaccination; symptoms before) | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | SLE (Diagnosed before vaccination) | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Temporomandibular joint disorder | 0.19 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Testicular torsion | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Thrombocytopenia (Chronic, diagnosed before vacc.) | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Tonsillitis | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Urinary tract infection | 0.10 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Viral syndrome | 0.03 Events per 1,000 doses |
Other Pre-specified
Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - 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 all 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 During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined. | Cardiac arrest | 0.03 Events per 1,000 doses |
| Menactra Vaccine Recipients | Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined. | Pregnancy | 0.03 Events per 1,000 doses |
Other Pre-specified
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Time frame: Day 0 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 Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Genital pain (ER) | 0.03 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Mononucleosis (ER) | 0.03 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Febrile illness (ER) | 0.25 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Tympanic perforation (H) | 0.03 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Hyperglycemia (ER) | 0.03 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Vomiting (ER) | 0.21 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Elective procedure (H) | 0.19 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Vomiting (ER) | 0.11 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Elective procedure (H) | 0.09 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Febrile illness (ER) | 0.13 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Genital pain (ER) | 0.00 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Hyperglycemia (ER) | 0.00 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Mononucleosis (ER) | 0.00 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Tympanic perforation (H) | 0.00 Events per 1,000 person-months |
Other Pre-specified
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.
Time frame: Day 0 up to Day 180 post-vaccination
Population: All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Hives/Urticaria (age 11-16 years; C) | 0.40 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Mononucleosis (age 17-18 years; ER) | 0.10 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Otitis Externa (age 11-16 years; ER) | 0.04 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Diabetes Type 1 (Prior onset)[age 11-16 years; ER] | 0.04 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Difficulty breathing/SOB (age 11-16 years; ER) | 0.07 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Elective procedure (age 11-16 years; H) | 0.20 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Febrile illness (age 11-16 years; ER) | 0.23 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Vomiting (age 11-16 years; ER) | 0.18 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Otitis Externa (age 11-16 years; ER) | 0.00 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Hives/Urticaria (age 11-16 years; C) | 0.24 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Elective procedure (age 11-16 years; H) | 0.06 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Vomiting (age 11-16 years; ER) | 0.09 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Febrile illness (age 11-16 years; ER) | 0.12 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Diabetes Type 1 (Prior onset)[age 11-16 years; ER] | 0.00 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Mononucleosis (age 17-18 years; ER) | 0.00 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Difficulty breathing/SOB (age 11-16 years; ER) | 0.02 Events per 1,000 person-months |
Other Pre-specified
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance
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 for each 30-day comparison window. Individuals receiving Menactra vaccine 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. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Time frame: Day 0 up to Day 60 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 Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Adominal pain (age 11-16 years; ER) | 1.07 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Febrile illness (age 11-16 years; ER) | 0.33 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Suicidal Ideation/Attempt (age 11-16 years; ER) | 0.23 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Adominal pain (age 11-16 years; ER) | 0.38 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Febrile illness (age 11-16 years; ER) | 0.05 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Suicidal Ideation/Attempt (age 11-16 years; ER) | 0.00 Events per 1,000 person-months |
Other Pre-specified
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Time frame: Day 0 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 Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Benign lesion (H) | 0.12 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Poisoning/Ingestion (H) | 0.02 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Pregnancy delivery (H) | 0.00 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Post-operative complication (ER) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Congenital anomaly (H) | 0.10 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Post-operative complication (H) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Allergic reaction (ER) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Fatigue (ER) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Psychiatric (ER) | 0.44 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Cyst (H) | 0.04 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Psychiatric (H) | 0.33 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Insect bite (ER) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Testicular pain (ER) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Allergy, drug (ER) | 0.00 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Tonsillitis (H) | 0.09 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Musculoskeletal pain (ER) | 0.27 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Trauma (ER) | 3.77 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Vision disorder (H) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Abscess/Cellulitis (ER) | 0.12 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Well care/Reassurance/Follow-up (ER) | 0.07 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Pelvic pain (ER) | 0.01 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Well care/Reassurance/Follow-up (ER) | 0.24 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Trauma (ER) | 5.13 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Abscess/Cellulitis (ER) | 0.25 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Allergic reaction (ER) | 0.06 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Allergy, drug (ER) | 0.03 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Benign lesion (H) | 0.24 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Cyst (H) | 0.10 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Fatigue (ER) | 0.04 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Insect bite (ER) | 0.05 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Musculoskeletal pain (ER) | 0.39 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Pelvic pain (ER) | 0.08 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Poisoning/Ingestion (H) | 0.07 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Post-operative complication (ER) | 0.07 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Post-operative complication (H) | 0.04 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Pregnancy delivery (H) | 0.03 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Psychiatric (ER) | 0.70 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Psychiatric (H) | 0.58 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Testicular pain (ER) | 0.05 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Tonsillitis (H) | 0.28 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Vision disorder (H) | 0.05 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Congenital anomaly (H) | 0.18 Events per 1,000 person-months |
Other Pre-specified
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
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 the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Time frame: Day 0 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 Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Congenital anomaly (age 11-16 years; H) | 0.09 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Benign lesion (age 11-16 years; H) | 0.09 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Psychiatric (age 17-18 years; ER) | 0.43 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Testicular pain (age 11-16 years; ER) | 0.01 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 11-16 years; ER) | 3.88 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Allergic reaction (age 11-16 years; ER) | 0.00 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Cyst (age 11-16 years; H) | 0.03 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Pelvic pain (age 17-18 years; ER) | 0.00 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Post-operative complication (age 17-18 years; ER) | 0.02 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Psychiatric (age 11-16 years; H) | 0.32 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Psychiatric (age 17-18 years; H) | 0.38 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Tonsillitis (age 11-16 years; H) | 0.09 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Tonsillitis (age 17-18 years; ER) | 0.04 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Tonsillitis (age 17-18 years; H) | 0.10 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 17-18 years; ER) | 3.62 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 19-29 years; ER) | 3.53 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 19-29 years; H) | 0.00 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 30-55 years; ER) | 2.52 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 30-55 years; H) | 0.00 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Well care/Reassurance/Follow-up (age 11-16 yrs;ER) | 0.05 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Well care/Reassurance/Follow-up (age 17-18 yrs;ER) | 0.10 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Abdominal pain (age 30-55 years; ER) | 0.21 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Abscess/Cellulitis (age 11-16 years; ER) | 0.06 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 30-55 years; H) | 1.05 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Tonsillitis (age 11-16 years; H) | 0.26 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Benign lesion (age 11-16 years; H) | 0.22 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Cyst (age 11-16 years; H) | 0.09 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 19-29 years; H) | 1.28 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Tonsillitis (age 17-18 years; ER) | 0.22 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Abdominal pain (age 30-55 years; ER) | 1.89 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Well care/Reassurance/Follow-up (age 17-18 yrs;ER) | 0.37 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Abscess/Cellulitis (age 11-16 years; ER) | 0.13 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Tonsillitis (age 17-18 years; H) | 0.39 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Allergic reaction (age 11-16 years; ER) | 0.04 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Congenital anomaly (age 11-16 years; H) | 0.21 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 11-16 years; ER) | 4.66 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 30-55 years; ER) | 9.41 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Pelvic pain (age 17-18 years; ER) | 0.17 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 17-18 years; ER) | 5.27 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Post-operative complication (age 17-18 years; ER) | 0.15 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Well care/Reassurance/Follow-up (age 11-16 yrs;ER) | 0.17 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Psychiatric (age 11-16 years; H) | 0.52 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Psychiatric (age 17-18 years; ER) | 1.34 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Trauma (age 19-29 years; ER) | 10.9 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Psychiatric (age 17-18 years; H) | 0.77 Events per 1,000 person-months |
| Control Group | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Testicular pain (age 11-16 years; ER) | 0.06 Events per 1,000 person-months |
Other Pre-specified
Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
Only persons who received Menactra vaccine during the study period were included in this outcome.
Time frame: Day 0 up to Determination of Pregnancy Outcome
Population: Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Recipients | Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Live births | 11 Paticipants |
| Menactra Vaccine Recipients | Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Live births with congenital anomaly (facial cyst) | 1 Paticipants |
| Menactra Vaccine Recipients | Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Elective abortion | 5 Paticipants |
| Menactra Vaccine Recipients | Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Early fetal death | 1 Paticipants |
| Menactra Vaccine Recipients | Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Lost to follow up | 7 Paticipants |