Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis, Meningococcal Infection, Menactra®
Brief summary
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose. Observational Objective: * To describe and characterize adverse events occurring after vaccination with Menactra vaccine.
Detailed description
The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees. Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Day 0 up to Day 75 post-vaccination | Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database. | Day 0 up to Day 75 post-vaccination | Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database. |
| Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database. | Day 0 up to Day 75 post-vaccination | Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database. |
Countries
United States
Participant flow
Recruitment details
Study participant accrual occurred from 16 June 2011 through 20 June 2014.
Pre-assignment details
Databases of Kaiser Permanente in Northern California (KPNC) were reviewed to describe and characterize adverse events occurring after use of Menactra vaccine in routine clinical practice. Rates of events occurring in a risk window for participants were compared with rates of events occurring in a control window for the same participants.
Participants by arm
| Arm | Count |
|---|---|
| Menactra Vaccine Recipients Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice. | 116 |
| Total | 116 |
Baseline characteristics
| Characteristic | Menactra Vaccine Recipients |
|---|---|
| Age, Categorical <=18 years | 116 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 15.9 Months STANDARD_DEVIATION 5.56 |
| Region of Enrollment United States | 116 Participants |
| Seasonality December - February | 30 Participants |
| Seasonality June - August | 22 Participants |
| Seasonality March - May | 39 Participants |
| Seasonality September - November | 29 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 |
Outcome results
Primary
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.
Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.
Time frame: Day 0 up to Day 75 post-vaccination
Population: Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Asthma | 0.009 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Cough | 0.009 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Febrile Seizure | 0.009 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Otitis Media | 0.009 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Trauma | 0.019 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Upper Respiratory Infection | 0.009 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Viral Syndrome | 0.009 Events per 1,000 person-months |
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Vomiting (ER) | 0.009 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Vomiting (ER) | 0.000 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Asthma | 0.006 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Trauma | 0.000 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Cough | 0.006 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Viral Syndrome | 0.000 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Febrile Seizure | 0.000 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Upper Respiratory Infection | 0.000 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. | Otitis Media | 0.000 Events per 1,000 person-months |
Other Pre-specified
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.
Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.
Time frame: Day 0 up to Day 75 post-vaccination
Population: All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database. | 0 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database. | 0 Events per 1,000 person-months |
Other Pre-specified
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.
Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.
Time frame: Day 0 up to Day 75 post-vaccination
Population: All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menactra Vaccine Recipients | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database. | 0 Events per 1,000 person-months |
| Control Group | Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database. | 0 Events per 1,000 person-months |