Mode
Text Size
Log in / Sign up
Phase 3 N=3,548 Randomized Quadruple-blind Prevention

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

SARS-CoV-2

Enrolled (actual)
3,548
Serious AEs
4.7%
Results posted
Aug 2024
Primary outcome: Primary: Part 1: Geometric Mean Concentration (GMC) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 — 537.7; 302.8 AU/mL

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
mRNA-1273.529 (Biological); mRNA-1273 (Biological); mRNA-1273.214 (Biological)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
ModernaTX, Inc.
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Part 1: Geometric Mean Concentration (GMC) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29
537.7; 302.8
PRIMARY
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 85
284.7; 152.6
PRIMARY
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 29
465.7; 311.0
PRIMARY
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 85
258.2; 153.0
PRIMARY
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain at Day 29
2998.8; 2933.6
PRIMARY
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain ay Day 85
1753.1; 1610.2
PRIMARY
Parts 1 and 2: Percentage of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
84.5; 89.1; 83.6; 89.9; 69.8; 74.2
PRIMARY
Parts 1 and 2: Number of Participants With Unsolicited AEs
142; 124; 442; 429
PRIMARY
Parts 1 and 2: Number of Participants With Serious AEs (SAEs)
20; 13; 60; 72
PRIMARY
Parts 1 and 2: Number of Participants With Medically Attended AEs (MAAEs)
242; 257; 956; 964
PRIMARY
Parts 1 and 2: Number of Participants With AEs Leading to Withdrawal
2; 3; 3; 6
PRIMARY
Parts 1 and 2: Number of Participants With AEs of Special Interest (AESIs)
42; 28; 60; 60
SECONDARY
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 and Day 85
537.7; 302.8; 284.7; 152.6
SECONDARY
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 179
144.3; 70.1
SECONDARY
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the Ancestral Strain at Day 29, Day 85, and Day 179
2699.7; 3020.6; 1401.2; 1559.4; 734.6; 747.6
SECONDARY
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2
83.2; 55.2; 84.7; 70.4; 48.3; 15.9
SECONDARY
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains
236533.1; 225834.1; 133951.9; 124778.3; 244715.5; 236066.3
SECONDARY
Part 2: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR)
16.9; 17.7
SECONDARY
Part 2: Percentage of Participants With Symptomatic SARS-CoV-2 Infection Measured by RT-PCR
50.8; 48.6
SECONDARY
Part 2: Percentage of Participants With Primary Case Definition of COVID-19
30.5; 29.1
SECONDARY
Part 2: Percentage of Participants With Secondary Case Definition of COVID-19
33.5; 30.9

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05249829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search