Maternal OutcomesNCT06369272
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
An observational study of Maternal Outcomes and Infant Outcomes, run by ModernaTX, Inc. at 1 site in United States.
Trial summary
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs). Read more about this study
- Who is it for?
- Ages 13 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Type of treatment
- Vaccines
- How many people
- 1,192 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 20 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Study population includes women for whom an LMP can be successfully calculated based on a non-missing end of pregnancy (EOP), and who also meet the eligibility criteria to be included in the study analyses.
Who may be able to join
- EOP within study period
- Continuous enrollment in a health plan contributing to the HealthCare Integrated Research Database℠ (HIRD) database for at least 90 days prior to the estimated LMP.
Who cannot join
- Exposure to any non-Moderna COVID-19 vaccines at any time prior to LMP and from LMP through the exposure ascertainment period for the outcome of interest. However, pregnant women exposed to other non-Moderna vaccines in addition to SPIKEVAX will be included in a sensitivity analysis.
- Instances where the outcome of a pregnancy is not documented (e.g., a prenatal care claim is followed by no further documentation of pregnancy, termination, or delivery where the participant remains enrolled in the health plan) may also be observed. The number of these possibly exposed pregnancies will be tabulated and described; however, they will not be included in the descriptive or comparative analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
The primary objectives of this study are:
In infants of women exposed to SPIKEVAX during pregnancy, to assess:
- If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
- If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
- In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders [e.g., pre-eclampsia, eclampsia, and gestational hypertension] gestational diabetes, and post-partum hemorrhage; and
- To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion.
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Keywords
- Maternal outcomes, Infant outcomes, Pregnancy, Observational, SPIKEVAX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SPIKEVAX Exposed Pregnancy | Cohort includes pregnant women who were vaccinated with SPIKEVAX from last menstrual period (LMP) through the exposure ascertainment period for the outcome of interest. | |
| SPIKEVAX Distantly Exposed Pregnancy | Cohort includes pregnant women who were exposed to SPIKEVAX at least 60 days prior to LMP and not exposed to SPIKEVAX or any other COVID-19 vaccine from LMP through the exposure ascertainment period for the outcome of interest. | |
| Unvaccinated During Pregnancy | Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest. | |
| COVID-19 Infected During Pregnancy | Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest. These women also had at least one medically attended COVID-19 episode during the exposure ascertainment period outcome of interest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MCMs
Measured: Up to approximately 3 years
Number of Adverse Neonatal and Infant Outcomes
Adverse neonatal and infant outcomes include neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, or incidence of hospitalization due to infections including COVID-19.
Measured: Up to approximately 3 years
Number of Participants with Hypertensive Disorders
Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage
Measured: Up to approximately 3 years
Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions
Measured: Up to approximately 3 years
Secondary outcomes (9)
Demographics: Participant Region of Residence
Measured: Baseline
Demographics: Age at LMP
Measured: Baseline
Demographics: Number of Overweight or Obese Participants
Measured: Baseline
Demographics: Duration of Health Plan Enrolment Prior to Pregnancy
Measured: Baseline
Demographics: Calendar Date of the Pregnancy Outcome
Measured: Baseline
Demographics: Participant Race and Ethnicity
Measured: Baseline
Demographics: Participant Socio-economic Status
Measured: Baseline
Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations
Measured: Baseline
Healthcare Utilization: Number of Distinct Medications Used
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal OutcomesStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The 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
- 1,192 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369272
- Sponsor's protocol ID
- mRNA-1273-P919
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
- ClinicalTrials.gov ID
- NCT06369272
- Acronym / sponsor ID
- mRNA-1273-P919
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Keywords
- Maternal outcomes, Infant outcomes, Pregnancy, Observational, SPIKEVAX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,192 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 16 Apr 2024 (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 primary objectives of this study are:
In infants of women exposed to SPIKEVAX during pregnancy, to assess:
- If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
- If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
- In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders [e.g., pre-eclampsia, eclampsia, and gestational hypertension] gestational diabetes, and post-partum hemorrhage; and
- To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPIKEVAX Exposed Pregnancy | – | –Cohort includes pregnant women who were vaccinated with SPIKEVAX from last menstrual period (LMP) through the exposure ascertainment period for the outcome of interest. |
| SPIKEVAX Distantly Exposed Pregnancy | – | –Cohort includes pregnant women who were exposed to SPIKEVAX at least 60 days prior to LMP and not exposed to SPIKEVAX or any other COVID-19 vaccine from LMP through the exposure ascertainment period for the outcome of interest. |
| Unvaccinated During Pregnancy | – | –Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest. |
| COVID-19 Infected During Pregnancy | – | –Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest. These women also had at least one medically attended COVID-19 episode during the exposure ascertainment period outcome of interest. |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population includes women for whom an LMP can be successfully calculated based on a non-missing end of pregnancy (EOP), and who also meet the eligibility criteria to be included in the study analyses.
Key inclusion criteria (2 listed)
- EOP within study period
- Continuous enrollment in a health plan contributing to the HealthCare Integrated Research Database℠ (HIRD) database for at least 90 days prior to the estimated LMP.
Key exclusion criteria (2 listed)
- Exposure to any non-Moderna COVID-19 vaccines at any time prior to LMP and from LMP through the exposure ascertainment period for the outcome of interest. However, pregnant women exposed to other non-Moderna vaccines in addition to SPIKEVAX will be included in a sensitivity analysis.
- Instances where the outcome of a pregnancy is not documented (e.g., a prenatal care claim is followed by no further documentation of pregnancy, termination, or delivery where the participant remains enrolled in the health plan) may also be observed. The number of these possibly exposed pregnancies will be tabulated and described; however, they will not be included in the descriptive or comparative analyses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of MCMs
Time frame: Up to approximately 3 years
Number of Adverse Neonatal and Infant Outcomes
Time frame: Up to approximately 3 years
Adverse neonatal and infant outcomes include neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, or incidence of hospitalization due to infections including COVID-19.
Number of Participants with Hypertensive Disorders
Time frame: Up to approximately 3 years
Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage
Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions
Time frame: Up to approximately 3 years
9 secondary outcomes
Demographics: Participant Region of Residence
Time frame: Baseline
Demographics: Age at LMP
Time frame: Baseline
Demographics: Number of Overweight or Obese Participants
Time frame: Baseline
Demographics: Duration of Health Plan Enrolment Prior to Pregnancy
Time frame: Baseline
Demographics: Calendar Date of the Pregnancy Outcome
Time frame: Baseline
Demographics: Participant Race and Ethnicity
Time frame: Baseline
Demographics: Participant Socio-economic Status
Time frame: Baseline
Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations
Time frame: Baseline
Healthcare Utilization: Number of Distinct Medications Used
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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 Maternal Outcomes and Infant Outcomes, run by ModernaTX, Inc. 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of MCMs (time frame: Up to approximately 3 years). The study lists 4 primary outcomes in all. 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 16 Apr 2024.