Trial Outcomes & Findings for Boostrix® Pregnancy Registry (NCT NCT02096276)
NCT ID: NCT02096276
Last Updated: 2020-12-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1517 participants
Primary outcome timeframe
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)
Results posted on
2020-12-19
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
55
|
|
Overall Study
COMPLETED
|
250
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exposure Group_Prospective
n=250 Participants
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)
|
Exposure Group_Retrospective
n=55 Participants
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
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Pregnant women (13-42 Years)
|
248 Participants
n=250 Participants
|
28 Participants
n=55 Participants
|
276 Participants
n=305 Participants
|
|
Age, Customized
Unknown
|
2 Participants
n=250 Participants
|
27 Participants
n=55 Participants
|
29 Participants
n=305 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=250 Participants
|
55 Participants
n=55 Participants
|
305 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=250 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=305 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposure Group_Prospective
n=250 Participants
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)
|
Exposure Group_Retrospective
n=55 Participants
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)
|
|---|---|---|
|
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
|
33 Participants
|
|
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
|
16 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
4 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
Adverse Events
Exposure Group_Prospective
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Exposure Group_Retrospective
Serious events: 1 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Exposure Group_Prospective
n=250 participants at risk
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)
|
Exposure Group_Retrospective
n=55 participants at risk
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)
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion without birth defects
|
1.2%
3/250 • 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)
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.
|
1.8%
1/55 • 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)
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.
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion with birth defects
|
0.00%
0/250 • 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)
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.
|
0.00%
0/55 • 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)
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.
|
|
Pregnancy, puerperium and perinatal conditions
Elective termination without birth defects
|
0.00%
0/250 • 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)
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.
|
0.00%
0/55 • 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)
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.
|
|
Pregnancy, puerperium and perinatal conditions
Elective termination with birth defects
|
0.00%
0/250 • 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)
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.
|
0.00%
0/55 • 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)
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER