Boostrix® Pregnancy Registry
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Exposure Group_Prospective Pregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and prospective (i.e., registration to registry is done before the outcome of the pregnancy is known) |
Other: Data collection
Initial and follow-up data will be collected using questionnaires.
|
| Exposure Group_Retrospective Pregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and retrospective (i.e., pregnancy outcome is already known at the time of registration to Registry) |
Other: Data collection
Initial and follow-up data will be collected using questionnaires.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Research Triangle Park | North Carolina | United States | 27709-3398 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
None provided.- 201327
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Exposure Group_Prospective | Exposure Group_Retrospective |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Period Title: Overall Study | ||
| STARTED | 250 | 55 |
| COMPLETED | 250 | 55 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Exposure Group_Prospective | Exposure Group_Retrospective | Total |
|---|---|---|---|
| Arm/Group Description | 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) | 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) | Total of all reporting groups |
| Overall Participants | 250 | 55 | 305 |
| Age, Customized (Count of Participants) | |||
| Pregnant women (13-42 Years) |
248
99.2%
|
28
50.9%
|
276
90.5%
|
| Unknown |
2
0.8%
|
27
49.1%
|
29
9.5%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
250
100%
|
55
100%
|
305
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
Outcome Measures
| Title | 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. |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on total cohort which included participants with known pregnancy outcomes. |
| Arm/Group Title | Exposure Group_Prospective | Exposure Group_Retrospective |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 250 | 55 |
| Live birth without birth defects |
244
97.6%
|
33
60%
|
| Live birth with birth defects |
3
1.2%
|
16
29.1%
|
| Spontaneous abortion without birth defects |
3
1.2%
|
1
1.8%
|
| Spontaneous abortion with birth defects |
0
0%
|
0
0%
|
| Stillbirth without birth defects |
0
0%
|
4
7.3%
|
| Stillbirth with birth defects |
0
0%
|
1
1.8%
|
| Elective termination without birth defects |
0
0%
|
0
0%
|
| Elective termination with birth defects |
0
0%
|
0
0%
|
Adverse Events
| 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) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Classification of events as SAE or other AE were unidentified. Pregnancy case reports were analyzed by case in scope of the Registry. Those cases may have had AEs co-reported. The systematic analysis of these AEs was not among the objectives of the study. | |||
| Arm/Group Title | Exposure Group_Prospective | Exposure Group_Retrospective | ||
| Arm/Group Description | 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) | 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) | ||
All Cause Mortality |
||||
| Exposure Group_Prospective | Exposure Group_Retrospective | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/250 (1.2%) | 6/55 (10.9%) | ||
Serious Adverse Events |
||||
| Exposure Group_Prospective | Exposure Group_Retrospective | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/250 (1.2%) | 1/55 (1.8%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Spontaneous abortion without birth defects | 3/250 (1.2%) | 1/55 (1.8%) | ||
| Spontaneous abortion with birth defects | 0/250 (0%) | 0/55 (0%) | ||
| Elective termination without birth defects | 0/250 (0%) | 0/55 (0%) | ||
| Elective termination with birth defects | 0/250 (0%) | 0/55 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Exposure Group_Prospective | Exposure Group_Retrospective | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/250 (0%) | 0/55 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| GSKClinicalSupportHD@gsk.com |
- 201327