Pertussis
Conditions
Keywords
Tetanus Toxoid,, acellular pertussis,, diphtheria toxoid
Brief summary
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.
Detailed description
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.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Receipt of ADACEL vaccine during the study period
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database | Days 0 to 60 and Day 61 to 120 following vaccination | 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. |
| Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database | Days 0 up to 180 following vaccination | 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. |
| All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | Days 0 to 60 and Day 61 to 120 following vaccination | 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 |
| All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | Days 0 to 180 following vaccination | 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. |
| Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Pregnancy to Delivery, up to 9 months | 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. |
| Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Pregnancy to Delivery, up to 9 months | 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. |
Countries
United States
Participant flow
Recruitment details
Study participant accrual occurred from 02 September 2005 through 16 October 2006 using 3 Kaiser Permanente databases.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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) | 124,139 |
| 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. | 203,154 |
| Total | 327,293 |
Baseline characteristics
| Characteristic | Adacel Vaccine Group | Control Groups | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50214 Participants | 58823 Participants | 109037 Participants |
| Age, Categorical >=65 years | 3064 Participants | 24941 Participants | 28005 Participants |
| Age, Categorical Between 18 and 65 years | 70861 Participants | 119390 Participants | 190251 Participants |
| Age, Continuous | 32.1 Years STANDARD_DEVIATION 19 | 39.0 Years STANDARD_DEVIATION 21.6 | 36.4 Years STANDARD_DEVIATION 20.9 |
| Region of Enrollment United States | 124139 participants | 203154 participants | 327293 participants |
| Seasonality (Time of vaccination) December to February | 20293 Participants | 42397 Participants | 62690 Participants |
| Seasonality (Time of vaccination) June to August | 49173 Participants | 62906 Participants | 112079 Participants |
| Seasonality (Time of vaccination) March to May | 35651 Participants | 51039 Participants | 86690 Participants |
| Seasonality (Time of vaccination) September to November | 19022 Participants | 46812 Participants | 65834 Participants |
| Sex: Female, Male Female | 67067 Participants | 104898 Participants | 171965 Participants |
| Sex: Female, Male Male | 57072 Participants | 98256 Participants | 155328 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 124,139 |
| serious Total, serious adverse events | 4 / 124,139 |
Outcome results
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.
Time frame: Days 0 to 180 following vaccination
Population: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacel Vaccine Group | All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | 0 Events per 1000 Person-months |
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
Time frame: Days 0 to 60 and Day 61 to 120 following vaccination
Population: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacel Vaccine Group | All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. | 0 Events Per 1000 Person-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.
Time frame: Pregnancy to Delivery, up to 9 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Specified congenital anomalies of lacrimal passage | 4 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Congenital chordee | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Cleft palate, unilateral, incomplete | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other penile anomalies | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Stenosis of pulmonary valve, congenital | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other obstructive defects of renal pelvis and uret | 1 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Cleft palate with cleft lip, unspecified | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Metatarsus varus | 1 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Ventricular septal defect | 1 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Polydactyly of fingers | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Tongue tie | 1 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Polydactyly of toes | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other congenital deformity of hip (joint) | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Patent ductus arteriosus | 2 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Vascular hamartomas | 1 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Undescended testis | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Congenital pigmentary anomalies of skin | 1 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Agenesis, hypoplasia, and dysplasia of lung | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other specified anomalies of skin | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Specified congenital anomalies of breast | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Down's syndrome | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Hypospadias | 2 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Congenital anomaly, unspecified | 0 Infants |
| Adacel Vaccine Group | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Encephalocele | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Congenital anomaly, unspecified | 2 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Polydactyly of toes | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other specified anomalies of skin | 2 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Specified congenital anomalies of breast | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Patent ductus arteriosus | 6 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Encephalocele | 0 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Specified congenital anomalies of lacrimal passage | 18 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Ventricular septal defect | 2 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Stenosis of pulmonary valve, congenital | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Agenesis, hypoplasia, and dysplasia of lung | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Cleft palate, unilateral, incomplete | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Cleft palate with cleft lip, unspecified | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Tongue tie | 6 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Undescended testis | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Hypospadias | 0 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Congenital chordee | 2 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other penile anomalies | 2 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other obstructive defects of renal pelvis and uret | 0 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Metatarsus varus | 0 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Polydactyly of fingers | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Other congenital deformity of hip (joint) | 1 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Vascular hamartomas | 2 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Congenital pigmentary anomalies of skin | 5 Infants |
| Control Groups | Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. | Down's syndrome | 1 Infants |
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.
Time frame: Pregnancy to Delivery, up to 9 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Early fetal death (20-27 weeks gestation) | 0 Participants |
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Ectopic pregnancy | 1 Participants |
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Life Birth | 165 Participants |
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Spontaneous abortion (<20 weeks gestation) | 21 Participants |
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Late fetal death (at least 28 weeks gestation) | 1 Participants |
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Elective abortion | 33 Participants |
| Adacel Vaccine Group | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Lost to follow-up | 4 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Ectopic pregnancy | 5 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Late fetal death (at least 28 weeks gestation) | 0 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Lost to follow-up | 20 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Life Birth | 442 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Elective abortion | 105 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Spontaneous abortion (<20 weeks gestation) | 102 Participants |
| Control Groups | Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls | Early fetal death (20-27 weeks gestation) | 1 Participants |
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.
Time frame: Days 0 to 60 and Day 61 to 120 following vaccination
Population: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacel Vaccine Group | Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database | 0 Events Per 1000 Person-months |
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.
Time frame: Days 0 up to 180 following vaccination
Population: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacel Vaccine Group | Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database | 0 Events Per 1000 Person-months |
| Control Groups | Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database | 0 Events Per 1000 Person-months |