Eligibility, female only, with Hepatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual PeriodPrimary· From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
Participants were followed from registration upon exposure to Twinrix within 28 days prior to conception until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.
Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second tr
Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
4
No Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
1
No Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
1
No Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First TrimesterPrimary· From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
Participants were followed from registration upon exposure to Twinrix during first trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.
Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second t
Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
3
Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
1
No Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
60
No Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
7
No Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
5
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second TrimesterPrimary· From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
Participants were followed from registration upon exposure to Twinrix during second trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.
Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second
Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
2
Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
11
No Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third TrimesterPrimary· From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
Participants were followed from registration upon exposure to Twinrix during third trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.
Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second t
Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
1
No Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified TrimesterPrimary· From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
Participants were followed from registration upon exposure to Twinrix during unspecified trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.
Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The se
Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Live Birth
Group
Value
95% CI
Exposure Group
7
No Congenital Abnormalities, Spontaneous Abortion
Group
Value
95% CI
Exposure Group
2
No Congenital Abnormalities, Fetal Death
Group
Value
95% CI
Exposure Group
0
No Congenital Abnormalities, Induced Abortion
Group
Value
95% CI
Exposure Group
0
Sponsor's own description
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.
This is a prospective, voluntary, observational, exposure-registration study. Twinrix is designated as Food and Drug Administration (FDA) Pregnancy Category C, which means that its safety in human pregnancy has not been determined. The Registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. Registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 4 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03619590.