A Phase 3b/4, Open-label Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Vaccine Formulations

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: t
View:

⁃ Subprotocol 1:

• ≥65 years of age at the time of signing the informed consent or ≥12 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.

• Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.

• Participants who are assigned female at birth or could become pregnant:

• i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.

⁃ ii) 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).

⁃ iii) Has agreed to continue adequate contraception through 28 days following vaccine administration.

Locations
United States
Georgia
DelRicht Research-Atlanta
RECRUITING
Atlanta
Louisiana
DelRicht Research-Baton Rouge
RECRUITING
Baton Rouge
DelRicht Research-New Orleans
RECRUITING
New Orleans
Mississippi
DelRicht Research-Gulfport
RECRUITING
Gulfport
Oklahoma
DelRicht Research-Tulsa
RECRUITING
Tulsa
Contact Information
Primary
Moderna WeCare Team
WeCareClinicalTrials@modernatx.com
+1-866-663-3762
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2026-05-11
Participants
Target number of participants: 832
Treatments
Experimental: mRNA-1283.251 Variant-containing Formulation
Participants will receive an intramuscular (IM) injection of a mRNA-1283.251 variant-containing formulation.
Related Therapeutic Areas
Sponsors
Leads: ModernaTX, Inc.

This content was sourced from clinicaltrials.gov