Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
Surveillance using a healthcare organization with large comprehensive medical encounter databases will be used in this study to identify any risks or uncommon events associated with use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a large population.
No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus Toxoid, acellular pertussis, diphtheria toxoid | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database | The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis. Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination. | Days 0 to 60 and Day 61 to 120 following vaccination |
| Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database | The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis. Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study. | Days 0 up to 180 following vaccination |
| All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Passive surveillance by review of Kaiser Permanente Medical Care Program (KPMCP) computerized records and state mortality tapes
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27388557 | Result | Baxter R, Hansen J, Timbol J, Pool V, Greenberg DP, Johnson DR, Decker MD. Post-licensure safety surveillance study of routine use of tetanus toxoid, reduced diphtheria toxoid and 5-component acellular pertussis vaccine. Hum Vaccin Immunother. 2016 Nov;12(11):2742-2748. doi: 10.1080/21645515.2016.1201622. Epub 2016 Jul 7. |
Not provided
Not provided
Databases were reviewed to identify persons who received Adacel vaccine and Td vaccinated historical controls. Two statistical analysis methods were used, risk interval and historic cohort method. Adacel-exposed pregnancy cases were matched to non-exposed pregnant controls (3:1 ratio).
Study participant accrual occurred from 02 September 2005 through 16 October 2006 using 3 Kaiser Permanente databases.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adacel Vaccine Group | Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination. |
| FG001 | Control Groups | For each pregnant individual receiving Adacel vaccine, 3 control individuals not given Adacel vaccine were matched on age and month of their first positive pregnancy test. For non-pregnant individuals, age-matched individuals were identified who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adacel Recipients Historic Cohort Method |
| |||||||||||||
| Adacel Recipients-Risk Interval Method |
| |||||||||||||
| Pregnancy Surveillance |
|
Participants who received Adacel vaccine during the study period and age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adacel Vaccine Group | Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination. Each non-pregnant recipient served as their own control for evaluation of acute events. Rates of events occurring during Day 0 to 60 following vaccination were compared to rates of events occurring during Day 61 to 120 following vaccination (Short-term surveillance) |
| 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 | Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database | The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis. Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination. | Individuals receiving Adacel vaccine served as their own control for evaluation of acute events. | Posted | Number | Events Per 1000 Person-months | Days 0 to 60 and Day 61 to 120 following vaccination |
Adverse events data surveillance period were only in Adacel vaccine recipients from the day of vaccination up to 6 months post-vaccination from the Outpatient, Emergency Room and Hospital databases.
Total number reported for the serious adverse events are events that were deemed possibly associated with the Adacel vaccine in the Outpatient, Emergency Room and Hospital databases.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adacel Vaccine Group | Participants who received Adacel vaccine during the study period. They are sub-grouped as those pregnant at the time of vaccination with Adacel or who became pregnant within 28 days after vaccination and other recipients are classified by age at vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bell Palsy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
Not provided
As a result of screening using The Risk Interval and The Historic Cohort methods incident rates for 1030 outcomes were flagged as elevated. In post-hoc manual review no safety signals were identified. Details highlighted in the manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Drector | Sanofi Pasteur Inc | RegistryContactus@sanofipasteur.com |
Not provided
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D004168 | Diphtheria Toxoid |
| C509326 | adacel |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination |
| Days 0 to 60 and Day 61 to 120 following vaccination |
| All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study. | Days 0 to 180 following vaccination |
| Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups. | Pregnancy to Delivery, up to 9 months |
| Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups. | Pregnancy to Delivery, up to 9 months |
| Aurora |
| Colorado |
| United States |
| Portland | Oregon | United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Control Groups | Non-pregnant individuals matched by age to individuals who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Seasonality (Time of vaccination) | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Adacel Vaccine Group | Participants who received Adacel vaccine during the study period. |
| OG001 | Control Groups | Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier. |
|
|
| Primary | Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database | The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis. Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study. | Individuals receiving Adacel vaccine served as their own control for evaluation of acute events. | Posted | Number | Events Per 1000 Person-months | Days 0 up to 180 following vaccination |
|
|
|
| Primary | All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination | Individuals receiving Adacel vaccine served as their own control for evaluation of acute events. | Posted | Number | Events Per 1000 Person-months | Days 0 to 60 and Day 61 to 120 following vaccination |
|
|
|
| Primary | All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study. | Individuals receiving Adacel vaccine served as their own control for evaluation of acute events. | Posted | Number | Events per 1000 Person-months | Days 0 to 180 following vaccination |
|
|
|
| Primary | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups. | All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine. | Posted | Number | Participants | Pregnancy to Delivery, up to 9 months |
|
|
|
| Primary | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups. | All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine. | Posted | Number | Infants | Pregnancy to Delivery, up to 9 months |
|
|
|
| 4 |
| 124,139 |
| 0 |
| 124,139 |
| Guillain-Barré syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 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.
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| Early fetal death (20-27 weeks gestation) |
|
| Late fetal death (at least 28 weeks gestation) |
|
| Elective abortion |
|
| Ectopic pregnancy |
|
| Lost to follow-up |
|
| Ventricular septal defect |
|
| Stenosis of pulmonary valve, congenital |
|
| Patent ductus arteriosus |
|
| Agenesis, hypoplasia, and dysplasia of lung |
|
| Cleft palate, unilateral, incomplete |
|
| Cleft palate with cleft lip, unspecified |
|
| Tongue tie |
|
| Undescended testis |
|
| Hypospadias |
|
| Congenital chordee |
|
| Other penile anomalies |
|
| Other obstructive defects of renal pelvis and uret |
|
| Metatarsus varus |
|
| Polydactyly of fingers |
|
| Polydactyly of toes |
|
| Other congenital deformity of hip (joint) |
|
| Vascular hamartomas |
|
| Congenital pigmentary anomalies of skin |
|
| Other specified anomalies of skin |
|
| Specified congenital anomalies of breast |
|
| Down's syndrome |
|
| Congenital anomaly, unspecified |
|