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Trial record 1 of 1 for:    NCT05031468
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Multisite Observational Maternal and Infant Study for COVID-19 (MOMI-Vax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05031468
Recruitment Status : Active, not recruiting
First Posted : September 2, 2021
Last Update Posted : April 19, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Flor Munoz, Baylor College of Medicine

Brief Summary:
This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants following maternal receipt of licensed or Emergency Use Authorization (EUA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines.

Condition or disease Intervention/treatment
COVID-19 Biological: Licensed or EUA SARS-CoV-2 vaccine

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Study Type : Observational
Actual Enrollment : 562 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Prospective Cohort Study of the Immunogenicity and Safety of SARS-CoV-2 Vaccines Administered During Pregnancy or Postpartum and Evaluation of Antibody Transfer and Durability in Infants
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1: Individuals vaccinated during pregnancy
Individuals who receive a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine during pregnancy (up to 200 individuals per vaccine type)
Biological: Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.

Group 2: Individuals vaccinated postpartum
Individuals who receive a SARS-CoV-2 vaccine postpartum (up to 65 individuals per vaccine type)
Biological: Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.

Group 3: Infants of individuals vaccinated during pregnancy
Infants of individuals who receive a SARS-CoV-2 vaccine during pregnancy (approximately 200 infants per vaccine type)
Biological: Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.

Group 4: Infants of individuals vaccinated postpartum
Infants of individuals who receive a SARS-CoV-2 vaccine postpartum (approximately 65 infants per vaccine type)
Biological: Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.

Group 5: Individuals receiving additional vaccines during pregnancy
Individuals who receive additional SARS-CoV-2 vaccine(s), beyond the primary series, during pregnancy (up to 200 individuals).
Biological: Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.

Group 6: Infants of individuals receiving additional vaccines during pregnancy
Infants of individuals who received additional SARS-CoV-2 vaccine(s), beyond the primary series, during pregnancy (approximately 200 infants).
Biological: Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.




Primary Outcome Measures :
  1. Change in Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Among Individuals Vaccinated During Pregnancy [ Time Frame: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12 ]
    The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of IgG enzyme-linked immunosorbent assay (ELISA), by vaccine type and/or platform (mRNA, viral vector, etc.).

  2. Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated During Pregnancy [ Time Frame: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12 ]
    The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of Neut antibodies by vaccine type, platform and dose regimen.

  3. GMT of Cord Blood IgG [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, overall and by vaccine type, platform and dose regimen.

  4. Ratio of Cord Blood IgG to Maternal Serum IgG [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, overall and by vaccine type, platform and dose regimen.

  5. Neut antibodies of cord blood [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in cord blood, overall and by vaccine type, platform and dose regimen.

  6. Ratio of cord blood Neut antibodies to maternal serum Neut antibodies [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, overall and by vaccine type and platform.

  7. Change GMT of serum IgG in Infants Born to Individuals Vaccinated During Pregnancy [ Time Frame: At delivery, 2 months of age, 6 months of age ]
    The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of IgG in infants, by vaccine type, platform and dose regimen.

  8. Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated During Pregnancy [ Time Frame: At delivery, 2 months of age, 6 months of age ]
    The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in infants, by vaccine type, platform and dose regimen.


Secondary Outcome Measures :
  1. Frequency of Maternal Outcomes [ Time Frame: At delivery ]
    The frequency of maternal outcomes among individuals receiving the SARS-CoV-2 vaccine during pregnancy or postpartum will be compared to background rates in the United States, overall and by vaccine type and platform.

  2. Frequency of Infant Outcomes [ Time Frame: At delivery ]
    The frequency of infant outcomes among infants born to individuals receiving the SARS-CoV-2 vaccine during pregnancy or postpartum will be compared to background rates in the United States, overall and by vaccine type and platform.

  3. GMT of Serum IgG Compared to Non-Pregnant Women [ Time Frame: 28 days post-vaccination ]
    GMT of Serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be compared to non-pregnant populations of women of childbearing age.

  4. GMT of Neut Antibodies Compared to Non-Pregnant Women [ Time Frame: 28 days post-vaccination ]
    GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be compared to non-pregnant populations of women of childbearing age.

  5. GMT of Serum IgG by Gestational Age at Vaccination [ Time Frame: 28 days post-vaccination ]
    GMT of serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy will be examined by gestational age at vaccination (trimester of gestation) and interval between vaccination and delivery, by vaccine type and platform.

  6. GMT of Neut Antibodies by Gestational Age at Vaccination [ Time Frame: 28 days post-vaccination ]
    GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy will be examined by gestational age at vaccination (trimester of gestation) and interval between vaccination and delivery, by vaccine type and platform.

  7. GMT of Serum IgG by Baseline Characteristics [ Time Frame: 28 days post-vaccination ]
    GMT of serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be examined by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.

  8. GMT of Neut Antibodies by Baseline Characteristics [ Time Frame: 28 days post-vaccination ]
    GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be examined by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.

  9. GMT of Cord Blood IgG by Gestational Age at Vaccination [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.

  10. Ratio of Cord Blood IgG to Maternal Serum IgG by Gestational Age at Vaccination [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.

  11. GMT of Cord Blood Neut Antibodies by Gestational Age at Vaccination [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT Neut antibodies in cord blood, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.

  12. Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Gestational Age at Vaccination [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.

  13. GMT of Cord Blood IgG by Baseline Characteristics [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.

  14. Ratio of Cord Blood IgG to Maternal Serum IgG by Baseline Characteristics [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.

  15. GMT of Cord Blood Neut Antibodies by Baseline Characteristics [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT Neut antibodies in cord blood, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.

  16. Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Baseline Characteristics [ Time Frame: At delivery ]
    Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.

  17. Change in GMT of IgG in Breast Milk [ Time Frame: 2 weeks postpartum, and 2, 6, and 12 months postpartum ]
    The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of IgG in breast milk, overall and by vaccine type and platform.

  18. Change in GMT of Immunoglobulin A (IgA) in Breast Milk [ Time Frame: 2 weeks postpartum, and 2, 6, and 12 months postpartum ]
    The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of IgA in breast milk, overall and by vaccine type and platform.

  19. Change in GMT of Neut Antibodies in Breast Milk [ Time Frame: 2 weeks postpartum, and 2, 6, and 12 months postpartum ]
    The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of Neut Antibodies in breast milk, overall and by vaccine type and platform.

  20. Change in GMT of Serum IgG Among Individuals Vaccinated Postpartum [ Time Frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 ]
    The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine postpartum will be assessed as the GMT of IgG, by vaccine type and/or platform.

  21. Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated Postpartum [ Time Frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 ]
    The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine postpartum will be assessed as the GMT of Neut antibodies, by vaccine type and/or platform.

  22. Change GMT of serum IgG in Infants Born to Individuals Vaccinated Postpartum [ Time Frame: 2 months of age, 6 months of age ]
    The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated postpartum will be assessed as the GMT of IgG in infants, by vaccine type and platform.

  23. Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated Postpartum [ Time Frame: 2 months of age, 6 months of age ]
    The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated postpartum will be assessed as the GMT of Neut antibodies in infants, by vaccine type and platform.

  24. Change in GMT of Serum IgG Among Individuals Receiving Additional Vaccine Dose(s) [ Time Frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 ]
    The kinetics and durability of maternal serum antibodies following receipt of additional dose(s) of SARS-CoV-2 vaccine in pregnant individuals who received vaccine prior to pregnancy, will be assessed as the GMT of IgG in serum, by vaccine type and platform.

  25. Change in GMT of Neut Antibodies Among Individuals Receiving Additional Vaccine Dose(s) [ Time Frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 ]
    The kinetics and durability of maternal serum antibodies following receipt of additional dose(s) of SARS-CoV-2 vaccine in pregnant individuals who received vaccine prior to pregnancy, will be assessed as the GMT of Neut antibodies, by vaccine type and platform.


Other Outcome Measures:
  1. Incidence of COVID-19 Infection Among Pregnant Individuals [ Time Frame: Up to postpartum month 12 ]
    The effectiveness of SARS-CoV-2 vaccines against maternal COVID-19 infection during pregnancy and postpartum will be assessed as the incidence of laboratory confirmed COVID-19 illness during study participation assessed through passive surveillance in individuals vaccinated during pregnancy or postpartum compared to rates in unvaccinated women of childbearing age, overall and by vaccine type and platform.

  2. Severity of COVID-19 Infection Among Pregnant Individuals [ Time Frame: Up to postpartum month 12 ]
    The effectiveness of SARS-CoV-2 vaccines against maternal COVID-19 infection during pregnancy and postpartum will be assessed as the severity of COVID-19 disease during study participation assessed through passive surveillance in individuals vaccinated during pregnancy or postpartum compared to rates in unvaccinated women of childbearing age, overall and by vaccine type and platform.

  3. Incidence of COVID-19 Infection Among Infants [ Time Frame: Up to 12 months of age ]
    The effectiveness of maternal antibodies to provide protection against SARS-CoV-2 will be assessed by examining the incidence of COVID-19 illness in infants in the first 12 months of life. Incidence of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in infants of individuals vaccinated in pregnancy or postpartum compared to background rates in infants of unvaccinated women of childbearing age, overall and by vaccine type and platform.

  4. Severity of COVID-19 Infection Among Infants [ Time Frame: Up to 12 months of age ]
    The effectiveness of maternal antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in infants of individuals vaccinated in pregnancy or postpartum vs. background rates in infants of unvaccinated women of childbearing age, overall and by vaccine type and platform.

  5. Incidence of COVID-19 Infection Among Breastfed Infants [ Time Frame: Up to 12 months of age ]
    The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the incidence of COVID-19 illness in infants in the first 12 months of life. The incidence of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants compared to not breastfed infants, by vaccine type and platform.

  6. Severity of COVID-19 Infection Among Breastfed Infants [ Time Frame: Up to 12 months of age ]
    The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants compared to not breastfed infants, by vaccine type and platform.

  7. Incidence of COVID-19 Infection Among Breastfed Infants by Vaccination Timing [ Time Frame: Up to 12 months of age ]
    The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants of individuals vaccinated during pregnancy compared to postpartum, overall and by vaccine type and platform.

  8. Severity of COVID-19 Infection Among Breastfed Infants by Vaccination Timing [ Time Frame: Up to 12 months of age ]
    The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants of individuals vaccinated during pregnancy compared to postpartum, overall and by vaccine type and platform.


Biospecimen Retention:   Samples Without DNA
Blood and breast milk samples will be collected from pregnant participants. Cord blood and serum samples will be collected from infant participants. Residual samples will be retained, for participants who consent to have these left over specimens used for secondary research studies.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant individuals and postpartum individuals (within 2 months of delivery) who will be or have been vaccinated with a licensed or EUA SARS-CoV-2 vaccine, and their infants will be enrolled. Individuals receiving additional SARS-CoV-2 vaccine (beyond the primary series) during pregnancy will also be enrolled. Upon delivery, the infants born to individuals who received vaccine during pregnancy will become study participants.
Criteria

Inclusion Criteria for Pregnancy Group (Group 1):

  • Pregnant individuals who are scheduled to receive or have received complete vaccination series of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation health status, or gestational age at enrollment)
  • Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures.

Inclusion Criteria for Postpartum Group (Group 3):

  • Individuals who are scheduled to receive or who have initiated vaccination series of any licensed or EUA SARS-CoV-2 vaccine within the first 2 months postpartum. (NOTE: no limitation on health status).
  • Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures (a separate consent form will be used for their infants).

Inclusion Criteria for Additional Dose(s) During Pregnancy Group (Group 5):

  • Pregnant individuals who received one dose or both doses of their primary vaccine series prior to pregnancy and are scheduled to receive or have received additional dose(s) of any licensed or EUA SARS-CoV-2 vaccine during pregnancy OR pregnant individuals who received complete vaccination series during pregnancy and are scheduled to receive or have received additional dose(s) of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation on health status or gestational age at enrollment). This applies to individuals who have completed their primary series and receive an additional dose during pregnancy.
  • Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures.

Inclusion Criteria for All Participants:

  • ≥18 years of age at time of enrollment
  • Understands and agrees to comply with all study procedures.
  • Agrees to sign medical release for herself and her infant to allow study staff to gather pertinent medical information, pregnancy outcome data, and medical information as needed.

Exclusion Criteria:

  • Behavioral (including a history of alcohol or drug abuse within 1 year prior to study enrollment) or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
  • Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05031468


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
United States, New York
New York University Langone Vaccine Center
New York, New York, United States, 10016
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center (UPMC) Magee - Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Flor Munoz, MD Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Flor Munoz, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05031468    
Other Study ID Numbers: STUDY00002767
3UM1AI148576-02S5 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be made available for sharing for secondary research, following de-identification.
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Data will be available for sharing immediately following publication of the results of this study, with no end date, with data sharing at the discretion of the Infectious Diseases Clinical Research Consortium (IDCRC).
Access Criteria: Data will be made available for sharing for secondary research with investigators/researchers upon written request, with provision of a methodologically sound proposal. The proposal will need approval from Division of Microbiology and Infectious Diseases (DMID) and any approvals required by the site or consortium. The data will be available for only the purpose outlined in the approved proposal. Proposals can be sent to Dr. Munoz at florm@bcm.edu.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flor Munoz, Baylor College of Medicine:
Immunization
Pregnancy
Lactation
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases