An Observational Study of Moderna COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)
NCT ID: NCT05765578
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1713 participants
OBSERVATIONAL
2023-03-08
2024-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Moderna-Only Vaccine/Booster Series (MMMM Group)
Individuals who previously received Moderna COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Moderna mRNA1273.222).
Moderna COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Moderna mRNA1273.222 Booster
Sterile liquid for injection. Intervention not administered through this study.
Pfizer-Only Vaccine/Booster Series (PPPP Group)
Individuals who previously received Pfizer COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Pfizer-BNT 162b2 bivalent booster).
Pfizer COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group
Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5).
Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group
Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5).
Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Interventions
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Moderna COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Moderna mRNA1273.222 Booster
Sterile liquid for injection. Intervention not administered through this study.
Pfizer COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Eligibility Criteria
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Inclusion Criteria
* Speaks, reads, and understands English.
* Is willing and able to submit vaccination card photo(s) or vaccination records.
* Is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device.
* Is fully vaccinated against COVID-19 per protocol specified criteria.
Exclusion Criteria
* Is pregnant or planning to become pregnant during the study period.
* Primary mailing address is a Post Office box, Army Post Office, Fleet Post Office, or Diplomatic Post Office address.
* Currently lives in a US military base located overseas, or US territories (Puerto Rico, US Virgin Islands, Guam, Northern Mariana Island, or American Samoa).
* Is currently participating in a COVID-19 vaccine clinical trial.
* Is currently receiving chemotherapy or has received chemotherapy in the past 6 months.
* Is currently taking steroids, such as prednisone, for any condition.
* Has been diagnosed with and taking immunosuppressants for rheumatoid arthritis, lupus or multiple sclerosis.
* Has received an organ transplant.
* Is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.
18 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Science37
Culver City, California, United States
Countries
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Other Identifiers
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mRNA-1273-P922
Identifier Type: -
Identifier Source: org_study_id
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