Twinrix Pregnancy Registry

Twinrix [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] Pregnancy Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03619590

Enrollment

245

Registered

2018-08-08

Start date

2001-05-18

Completion date

2017-09-15

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis

Keywords

Teratogenicity, Pregnancy, Hepatitis B, Twinrix, Prenatal exposure, Hepatitis A

Brief summary

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.

Detailed description

The Twinrix Pregnancy Registry will be maintained by GSK Vaccines Clinical Safety and Pharmacovigilance. Enrolment in the Registry will begin at the time of commercial launch of Twinrix in the United States (US). At the time of initiation of the Registry, pre-existing reports of pregnancy from clinical trials will be evaluated and enrolled when the criteria for registration are met. Reporting of exposed pregnancies is voluntary. Pregnancies will be registered following maternal exposure to Twinrix within 28 days prior to conception or during pregnancy. Registration of pregnancies is prospective, i.e., reported during pregnancy before the pregnancy outcome is known. Retrospective reports, in which the pregnancy outcomes are known at the time of reporting, will also be reviewed to assist in the detection of any unusual patterns that may exist among the reported birth defects. However, because there is no denominator from which risk can be calculated, these reports will be excluded from the analysis.

Interventions

OTHERData Collection

When the pregnancy is reported prospectively, the Registry will collect registration data from the reporter through telephone interview or a short registration form. In the month of the estimated date of delivery, follow-up will be sought by telephone contact or a form mailed to the health professional. Information about maternal events throughout the pregnancy, pregnancy outcome, and neonatal health is requested. Additional follow-up is not sought from subsequent health care providers.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Documentation that Twinrix was administered ≤ 28 days before or during pregnancy; * Confirmation that the pregnancy is being prospectively reported; * Report made by a patient or a health care professional; * The timing of the prenatal exposure to Twinrix (no broader than during which trimester); * A patient identifier that will allow follow-up to be obtained so that the pregnancy outcome can be ascertained; * Whether the patient was involved in a clinical trial at the time of the exposure; * Full reporter contact information.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period	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 trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths.
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester	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 trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths.
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester	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 trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths.
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester	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 trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths.
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester	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 second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths.

Participant flow

Recruitment details

Study population included pregnant women who prospectively reported exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. 245 pregnancies were prospectively registered in the study. 142 pregnancies were lost to follow-up. Outcomes were reported for 103 pregnancies. Hence, the number of subjects started is 103.

Pre-assignment details

A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester, respectively.

Participants by arm

Arm	Count
Exposure Group Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.	103
Total	103

Baseline characteristics

Characteristic	Exposure Group	—
Age, Customized > 18 and < 65 years	94 Participants	—
Age, Customized ≤ 18 years	1 Participants	—
Age, Customized ≥ 65 years	0 Participants	—
Age, Customized Age not specified	8 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	103 Participants	—
Sex: Female, Male Male	0 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester

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 trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths.