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A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05249829
Recruitment Status : Recruiting
First Posted : February 22, 2022
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE February 19, 2022
First Posted Date  ICMJE February 22, 2022
Last Update Posted Date April 18, 2022
Actual Study Start Date  ICMJE February 16, 2022
Estimated Primary Completion Date April 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
  • Geometric Mean Titer (GMT) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Up to Day 179 post-vaccination ]
  • Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days post-vaccination) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 29 (28 days post-vaccination) ]
  • Number of Participants with Serious AEs (SAEs) [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with Medically Attended AEs (MAAEs) [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with AEs Leading to Withdrawal [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with AEs of Special Interest (AESIs) [ Time Frame: Day 1 to end of study (Day 359) ]
  • GMT of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain [ Time Frame: Up to Day 179 post-vaccination ]
  • GMT of mRNA-1273.214 and mRNA-1273 Against the Prototype Strain [ Time Frame: Up to Day 179 post-vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2022)
  • Geometric Mean Titer (GMT) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 After Study Vaccine Administration [ Time Frame: Day 29 ]
  • Geometric Mean Fold Rise (GMFR) of mRNA-1273.529 Against the B.1.1.529 Strain [ Time Frame: Day 29 ]
  • Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days post-vaccination) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 29 (28 days post-vaccination) ]
  • Number of Participants with Serious AEs (SAEs) [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with Medically Attended AEs (MAAEs) [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with AEs Leading to Withdrawal [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with AEs of Special Interest (AESIs) [ Time Frame: Day 1 to end of study (Day 359) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
  • GMT of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMT of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMFR of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMFR of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • Seroresponse Rate of Vaccine Recipients [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMT of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains [ Time Frame: Days 29, 85, and 179 ]
  • GMT of mRNA-1273.214 Against the B.1.1.529 Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMT of mRNA-1273.214 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMFR of mRNA-1273.214 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMFR of mRNA-1273.214 and mRNA-1273 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • Number of Participants with Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR) [ Time Frame: Day 1 to end of study (Day 359) ]
  • Number of Participants with Symptomatic SARS-CoV-2 Infection Measured by RT-PCR [ Time Frame: Day 1 to end of study (Day 359) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2022)
  • GMT of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Days 1, 85, 179, and 359 ]
  • GMT of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMFR of mRNA-1273.529 Against the B.1.1.529 Strain [ Time Frame: Days 1, 85, 179, and 359 ]
  • GMFR of mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • GMFR of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
  • Seroresponse Rate of Vaccine Recipients [ Time Frame: Days 1, 29, 85, 179, and 359 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19
Official Title  ICMJE A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 (Prototype) Booster Vaccine
Brief Summary This is a 2-part study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 and mRNA-1273.214 administered as a booster dose.
Detailed Description

In Part 1, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.529 or mRNA-1273.

In Part 2, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.214 or mRNA-1273.

All participants will have previously received 2 or 3 doses of an authorized/approved COVID-19 vaccine. Participants who previously received 2 doses of a COVID-19 vaccine as a primary series will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 3rd dose, and participants who have previously received a primary series and 1 booster dose will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 4th dose (a mixed approach is acceptable).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Biological: mRNA-1273.529
    Sterile liquid for injection
  • Biological: mRNA-1273
    Sterile liquid for injection
  • Biological: mRNA-1273.214
    Sterile liquid for injection
Study Arms  ICMJE
  • Experimental: Part 1: mRNA-1273.529
    Participants will receive 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1.
    Intervention: Biological: mRNA-1273.529
  • Active Comparator: Part 1: mRNA-1273
    Participants will receive 1 IM dose of mRNA-1273 on Day 1.
    Intervention: Biological: mRNA-1273
  • Experimental: Part 2: mRNA-1273.214
    Participants will receive 1 IM dose of mRNA-1273.214 on Day 1.
    Intervention: Biological: mRNA-1273.214
  • Active Comparator: Part 2: mRNA-1273
    Participants will receive 1 IM dose of mRNA-1273 on Day 1.
    Intervention: Biological: mRNA-1273
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2022)
3924
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2022)
2924
Estimated Study Completion Date  ICMJE April 7, 2023
Estimated Primary Completion Date April 7, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1; has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1); and has agreed to continue adequate contraception through 90 days following vaccine administration.
  • Participant has received 2 prior doses of one of the following approved/authorized COVID-19 vaccines: Moderna, Pfizer/BioNTech, Oxford/AstraZeneca, Janssen. A heterologous vaccine regimen is acceptable.
  • Participants who will receive the 4th dose as part of the study must have previously received a mRNA vaccine (Moderna or Pfizer/BioNTech) as the 3rd dose of a COVID-19 vaccine. Participants who will receive the 3rd dose as part of the study may have previously received 2 doses of an approved/authorized mRNA or a non-mRNA COVID-19 vaccine (a heterologous vaccine regimen is acceptable).

Exclusion Criteria:

  • Participant had close contact (without personal protective equipment [PPE]) as defined by the Centers for Disease Control and Prevention (CDC) in the past 14 days to someone diagnosed with SARS-CoV-2 infection or COVID-19 within 10 days of the close contact. Participants may be rescreened after 14 days provided that they remain asymptomatic.
  • Participant is acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1.
  • Participant has tested positive for SARS-CoV-2 by an authorized/approved lateral flow/rapid antigen or polymerase chain reaction (PCR) test within 90 days of Screening.
  • Participant has received a COVID-19 vaccine within 90 days of the Screening Visit.
  • Participant has received a total of 4 doses or more of COVID-19 vaccine.
  • Participant has received a COVID-19 vaccine at a dose different from the authorized/approved dose.
  • Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Participant has received or plans to receive any licensed vaccine ≤28 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 28 days after the study injection (with the exception that approved seasonal influenza vaccine may be received by at least 7 days and preferably 14 days apart from the study injection).
  • Participant has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
  • Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Note: Other inclusion and exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05249829
Other Study ID Numbers  ICMJE mRNA-1273-P305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ModernaTX, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ModernaTX, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP