Herpes ZosterNCT05811754
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
An observational study of Herpes Zoster, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 2,844 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Adult pregnant women, 18-49 years of age, diagnosed with an immunocompromised condition who were members of any of the 4 participating Sentinel Research Partners.
Who may be able to join
- Participant who is pregnant with a pregnancy start date between 01 July 2021 and 30 June 2026. Live births are to be followed for 1 year.
- Participant is a female aged 18-49 years on the pregnancy start date.
- Participant meets study definition of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO)/psoriatic arthritis (PsA), solid organ transplant (SOT), stem cell transplant (SCT), hematologic malignancies (HM), solid tumors (ST), or human immunodeficiency virus (HIV). Codes for immunocompromised conditions will be identified in the health plan claims of the Distributed Research Network (DRN) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). Diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit.
- Participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. The 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. In Sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored.
Who cannot join
- Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations.
- Participant delivered an infant identified as having a chromosomal or genetic anomaly.
- Ectopic pregnancies, molar pregnancies or induced abortions.
- Multigestation (e.g., twin) pregnancies.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Canton, Massachusetts, 02021
About this study
Official title: Post-marketing Commitment Safety Study of HZ/su to Evaluate Pregnancy Exposures and Outcomes in Immunodeficient or Immunosuppressed Women Between 18 and 49 Years of Age
The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs).
- Conditions
- Herpes Zoster
- Being tested
- Data collection
- Keywords
- Herpes Zoster, Recombinant, Zoster vaccine, Targeted, Safety study, Post-authorization safety study, Pregnant women
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
This study will be conducted using data provided by U.S. Research Partners in the FDA's Sentinel Surveillance System.
Four Research Partners will participate in this study: CVS Health Clinical Trial Services (CTS), Carelon Research, Optum and Harvard Pilgrim Health Care Institute (HPHCI).
| Study group | Role | What they receive |
|---|---|---|
| HZ/su-Exposed Group | Pregnancies among adult women diagnosed with immunocompromised conditions who were exposed to the HZ/su vaccine during pregnancy. Receives: Other: Data collection | |
| Comparison (Unexposed) Group | Pregnancies among adult women diagnosed with immunocompromised conditions who were not exposed to the HZ/su vaccine during pregnancy. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Major Congenital Malformations (MCMs)
The prevalence of MCMs among live births from women with immunocompromised conditions exposed to HZ/su vaccine compared to those not exposed to HZ/su vaccine during pregnancy is evaluated.
An MCM (birth defect or structural defect) is defined as a defect, which has either cosmetic or functional significance to the child.
Measured: From birth up to 1 year of age
Secondary outcomes (7)
Prevalence of additional infant/birth outcomes (small for gestational age, low birthweight, neonatal intensive care unit admission)
The prevalence of small for gestational age, low birthweight, neonatal intensive care unit admission among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: Within 30 days after the infant's date of birth
Prevalence of additional infant/birth outcome (preterm birth)
The prevalence of the preterm births among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: At birth
Prevalence of additional infant/birth outcome (neonatal death)
The prevalence of the neonatal deaths among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: Within 28 days after birth
Prevalence of pregnancy outcomes (live birth)
The prevalence of the live birth pregnancies among all eligible pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: At birth
Prevalence of pregnancy outcomes (stillbirth)
The prevalence of the stillbirth pregnancies among all eligible pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: At or after 20 weeks' gestation but prior to delivery
Prevalence of pregnancy outcomes (spontaneous abortion)
The prevalence of the spontaneous abortions among all eligible pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: Prior to 20 weeks' gestation
Prevalence of pregnancy complications
The prevalence of pregnancy complications (placental abruption, preeclampsia and eclampsia) among livebirth and non-livebirth pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Measured: From 20 weeks' gestation through the date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start9 May 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,844 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harvard Pilgrim Health Care Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811754
- Sponsor's protocol ID
- 214420
- Status last verified
- Aug 2025
- First submitted
- 31 Mar 2023
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Commitment Safety Study of HZ/su to Evaluate Pregnancy Exposures and Outcomes in Immunodeficient or Immunosuppressed Women Between 18 and 49 Years of Age
- ClinicalTrials.gov ID
- NCT05811754
- Acronym / sponsor ID
- 214420
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster, Recombinant, Zoster vaccine, Targeted, Safety study, Post-authorization safety study, Pregnant women
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,844 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Harvard Pilgrim Health Care Institute
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HZ/su-Exposed Group | – | Other: Data collectionPregnancies among adult women diagnosed with immunocompromised conditions who were exposed to the HZ/su vaccine during pregnancy. |
| Comparison (Unexposed) Group | – | Other: Data collectionPregnancies among adult women diagnosed with immunocompromised conditions who were not exposed to the HZ/su vaccine during pregnancy. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult pregnant women, 18-49 years of age, diagnosed with an immunocompromised condition who were members of any of the 4 participating Sentinel Research Partners.
Key inclusion criteria (4 listed)
- Participant who is pregnant with a pregnancy start date between 01 July 2021 and 30 June 2026. Live births are to be followed for 1 year.
- Participant is a female aged 18-49 years on the pregnancy start date.
- Participant meets study definition of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO)/psoriatic arthritis (PsA), solid organ transplant (SOT), stem cell transplant (SCT), hematologic malignancies (HM), solid tumors (ST), or human immunodeficiency virus (HIV). Codes for immunocompromised conditions will be identified in the health plan claims of the Distributed Research Network (DRN) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). Diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit.
- Participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. The 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. In Sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored.
Key exclusion criteria (4 listed)
- Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations.
- Participant delivered an infant identified as having a chromosomal or genetic anomaly.
- Ectopic pregnancies, molar pregnancies or induced abortions.
- Multigestation (e.g., twin) pregnancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThis study will be conducted using data provided by U.S. Research Partners in the FDA's Sentinel Surveillance System. Four Research Partners will participate in this study: CVS Health Clinical Trial Services (CTS), Carelon Research, Optum and Harvard Pilgrim Health Care Institute (HPHCI). | Other | Comparison (Unexposed) Group, HZ/su-Exposed Group |
Primary outcome
Prevalence of Major Congenital Malformations (MCMs)
Time frame: From birth up to 1 year of age
The prevalence of MCMs among live births from women with immunocompromised conditions exposed to HZ/su vaccine compared to those not exposed to HZ/su vaccine during pregnancy is evaluated. An MCM (birth defect or structural defect) is defined as a defect, which has either cosmetic or functional significance to the child.
7 secondary outcomes
Prevalence of additional infant/birth outcomes (small for gestational age, low birthweight, neonatal intensive care unit admission)
Time frame: Within 30 days after the infant's date of birth
Prevalence of additional infant/birth outcome (preterm birth)
Time frame: At birth
Prevalence of additional infant/birth outcome (neonatal death)
Time frame: Within 28 days after birth
Prevalence of pregnancy outcomes (live birth)
Time frame: At birth
Prevalence of pregnancy outcomes (stillbirth)
Time frame: At or after 20 weeks' gestation but prior to delivery
Prevalence of pregnancy outcomes (spontaneous abortion)
Time frame: Prior to 20 weeks' gestation
Prevalence of pregnancy complications
Time frame: From 20 weeks' gestation through the date of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Major Congenital Malformations (MCMs) (time frame: From birth up to 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.