Phase 3
N=30,415
A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
SARS-CoV-2
Bottom Line
View on ClinicalTrials.gov: NCT04470427 ↗Enrolled (actual)
30,415
Serious AEs
3.0%
Results posted
Mar 2024
Primary outcome: Primary: Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose — 744; 55 Participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mRNA-1273 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose |
744; 55 | <.0001 sig |
| PRIMARY Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose |
5134; 9329; 1782; 3134; 363; 849 | — |
| PRIMARY Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose |
4346; 4847; 1558; 5800; 348; 2895 | — |
| PRIMARY Parts A and B: Number of Participants With Medically Attended AEs (MAAEs) and AEs Leading to Discontinuation |
4561; 3921; 109; 5513; 5809; 25 | — |
| PRIMARY Parts A and B: Number of Participants With Serious AEs (SAEs) |
308; 292; 15; 536; 516 | — |
| SECONDARY Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose |
4338; 4752 | — |
| SECONDARY Parts A and B: Number of Participants With a First Occurrence of Severe COVID-19 Starting 14 Days After Second Dose |
106; 2; 1; 8; 1 | — |
| SECONDARY Part A: Number of Participants With a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection Regardless of Symptomatology or Severity Starting 14 Days After Second Dose |
1339; 280 | — |
| SECONDARY Part A: Number of Participants With a Secondary Case Definition of COVID-19 Starting 14 Days After Second Dose |
807; 58 | — |
| SECONDARY Parts A and B: Number of Participants Who Died Due to a Cause Directly Attributed to a Complication of COVID-19 Starting 14 Days After Second Dose |
3; 0; 0; 0; 0 | — |
| SECONDARY Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After First Dose |
769; 56 | — |
| SECONDARY Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose Regardless of Evidence of Prior SARS-CoV-2 Infection |
754; 58 | — |
| SECONDARY Part A: Number of Participants With a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 Days After Second Dose |
498; 214 | — |
| SECONDARY Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) |
NA; 9.624; 9.515; 54.866; 9.903; 1081.124 | — |
| SECONDARY Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb |
1.03; 5.69; 1.07; 112.30; 1.02; 2.68 | — |
| SECONDARY Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 |
0.7; 81.4; 1.4; 98.9; 0.7; 63.0 | — |
| SECONDARY Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62) |
163.848; 8122.189; 2951.123 | — |
| SECONDARY Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 Measured by Pseudovirus (VAC62) |
94.5; 89.2 | — |
| SECONDARY Part C: Geometric Mean Concentration (GMC) of SARS-CoV-2 Specific nAb After BD Compared to After Second Dose in Part A Measured by Pseudovirus (VAC62) |
7739.680; 1111.274 | — |
| SECONDARY Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 After BD Compared to After Second Dose in Part A |
100; 98.8 | — |
Summary
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.
Eligibility Criteria
Inclusion Criteria
- (Part A only) Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Able to comply with study procedures based on the assessment of the Investigator.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
- Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- Has a negative pregnancy test at Screening and on the day of the first dose (Day 1, open-label Day 1, and booster dose 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).
- Has agreed to continue adequate contraception through 3 months following the last dose (Day 29, open-label Day 29, and booster dose Day 1).
- Is not currently breastfeeding.
- Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- (Part C Only) Is currently enrolled in Part B of the current study (mRNA-1273-P301).
- (Part C Only) Has received at least 1 dose of mRNA-1273 in the current study (mRNA-1273-P301).
Exclusion Criteria
- Is acutely ill or febrile 72 hours prior to or at Screening or dosing (Part B and Part C). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the Investigator.
- Is pregnant or breastfeeding.
- (Part A Only) Known history of SARS-CoV-2 infection.
- Prior (Part A) or concurrent (Part B and Part C) administration of non-study coronavirus (SARS-CoV, Middle East Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
- (Part A Only) Demonstrated inability to comply with the study procedures.
- An immediate family member or household member of this study's personnel.
- Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
- Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
- Has received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (IP) (except for seasonal influenza vaccine).
- (Part A only) Has participated in an interventional clinical study within 28 days prior to the day of enrollment.
- Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.
- Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to IP dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent).
- Has received systemic immunoglobulins or blood products within 3 months prior to the day of IP dose administration.
- Has donated ≥450 milliliters (mL) of blood products within 28 days prior to IP dose administration.
Data sourced from ClinicalTrials.gov (NCT04470427). 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.