Pertussis
Conditions
Keywords
Pregnancy Registry, Boostrix, Women, Cohort, Prospective, Pregnancy outcome, Exploratory
Brief summary
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively
Detailed description
The Registry was originally initiated on 03 May 2005, as part of a program of enhanced pharmacovigilance. Following new European Union Pharmacovigilance legislation, pregnancy registries are to be considered as post-authorization safety studies (PASS). The ongoing Registry will therefore be converted into a PASS study in Q1 2014. Exposed pregnancies reported to the Registry before the transition into a PASS (between 03 May 2005 and Q1 2014), from which data were collected and analyzed prospectively, will also be included in the analyses. Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports. Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births for whom the contact details of their HCP will be available) to ascertain the presence of birth defects not diagnosed before, from Q1 2014 to Q3 2019.
Interventions
OTHERData collection
Initial and follow-up data will be collected using questionnaires.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
A subject will be included in the Registry if all of the following criteria are met: * Exposure to vaccine occurs during pregnancy or within 28 days preceding conception. * Subject is a US resident. * A HCP is identified (name, address and phone number). * Subject can be identified (by GSK or HCP). Data from registered subjects will be included in the analyses if the following criterion is met: • Pregnancy is ongoing and the outcome is unknown.
Exclusion criteria
Data from registered subjects will not be included in the analyses if the following criterion is met: • Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Typically, pregnancies \> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group) | Pregnancy outcomes included live births, spontaneous abortions (pregnancy loss \<22 weeks of gestation), stillbirths (pregnancy loss ≥22 weeks of gestation) and elective terminations. Each pregnancy outcome was further classified according to the presence or absence of a birth defect. |
Countries
United States
Participant flow
Pre-assignment details
Total of 1517 pregnancy reports (1455 prospective and 62 retrospective) were collected in the Boostrix US Pregnancy Registry. Of the 1455 prospective reports, 250 had known pregnancy outcomes, 1188 were lost to follow-up and 17 pregnancies were ongoing. Of the 62 retrospective reports, 55 had known pregnancy outcomes and 7 were lost to follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Exposure Group_Prospective Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and prospective (i.e., registration to registry was done before the outcome of the pregnancy is known) | 250 |
| Exposure Group_Retrospective Pregnant women within the United States (US) who were exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies was voluntary and retrospective (i.e., pregnancy outcome was already known at the time of registration to Registry) | 55 |
| Total | 305 |
Baseline characteristics
| Characteristic | Exposure Group_Prospective | Exposure Group_Retrospective | Total |
|---|---|---|---|
| Age, Customized Pregnant women (13-42 Years) | 248 Participants | 28 Participants | 276 Participants |
| Age, Customized Unknown | 2 Participants | 27 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 250 Participants | 55 Participants | 305 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 250 | 6 / 55 |
| other Total, other adverse events | 0 / 250 | 0 / 55 |
| serious Total, serious adverse events | 3 / 250 | 1 / 55 |
Outcome results
Primary
Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception.
Pregnancy outcomes included live births, spontaneous abortions (pregnancy loss \<22 weeks of gestation), stillbirths (pregnancy loss ≥22 weeks of gestation) and elective terminations. Each pregnancy outcome was further classified according to the presence or absence of a birth defect.
Time frame: Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group)
Population: The analysis was performed on total cohort which included participants with known pregnancy outcomes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Live birth without birth defects | 244 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Live birth with birth defects | 3 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Spontaneous abortion without birth defects | 3 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Spontaneous abortion with birth defects | 0 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Stillbirth without birth defects | 0 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Stillbirth with birth defects | 0 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Elective termination without birth defects | 0 Participants |
| Exposure Group_Prospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Elective termination with birth defects | 0 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Elective termination with birth defects | 0 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Live birth without birth defects | 33 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Stillbirth without birth defects | 4 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Live birth with birth defects | 16 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Elective termination without birth defects | 0 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Spontaneous abortion without birth defects | 1 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Stillbirth with birth defects | 1 Participants |
| Exposure Group_Retrospective | Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. | Spontaneous abortion with birth defects | 0 Participants |