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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None administered in this study | Biological | N/A in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 up to Day 30 post-vaccination |
| 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. | Day 31 up to Day 180 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 up to 6 months post-vaccination |
Inclusion Criteria:
Exclusion Criteria:
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Past receipt of Menactra vaccine
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29550195 | Derived | Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
Study participant accrual occurred from 18 October 2007 through 17 October 2010. Kaiser Permanente databases were reviewed for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children 2 through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 30 post-vaccination |
|
Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital Anomaly of ureter | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Drector | Sanofi Pasteur Inc | RegistryContactus@sanofipasteur.com |
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Seasonality | Data represent participants receiving vaccine during each time period shown. One participant had received more than one dose of Menactra vaccine; each dose is counted in the seasonality section. | Number | Participants |
|
| Indication for Vaccination | Based on automated subject data. Participants may be included in more than 1 category | Number | Participants |
|
|
|
| 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. | Only persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 doses | Day 0 up to 6 months post-vaccination |
|
|
|
| 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. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 31 up to Day 180 post-vaccination |
|
|
|
| 16 |
| 1,421 |
| 0 |
| 1,421 |
| Sickle Cell Anemia | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Febrile Illness | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Feeding problem | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pyogenic arthritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Respiratory infection, upper | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Psychiatric | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Digestive congenital anomalies | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Congenital atresia | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cerebral palsy | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cellulitis and abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Hereditary spherocytosis | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Malignant neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Other non-traumatic joint disorders | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Title | Measurements |
|---|---|
|
| Cellulitis and abscess |
|
| Cerebral palsy |
|
| Congenital anomaly of ureter |
|
| Congenital atresia |
|
| Digestive congenital anomalies |
|
| Febrile illness |
|
| Feeding problem |
|
| Hereditary spherocytosis |
|
| Hydronephrosis |
|
| Malignant neoplasm |
|
| Other non-traumatic joint disorders |
|
| Pneumonia |
|
| Psychiatric |
|
| Pyogenic arthritis |
|
| Respiratory infection, upper |
|
| Sickle cell anemia |
|
| Small bowel obstruction |
|
| Trauma |
|