RECRUITING

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations

Conditions

COVID-19 mRNA-1283 mRNA-1283 vaccine SARS-CoV-2 SARS-CoV-2 Vaccine Coronavirus Coronavirus Infections Virus Diseases mNEXSPIKE®COVID-19 vaccine Moderna

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-21

Study Completion:2026-05-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07089706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥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:	* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment. * Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number. * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Receipt of the COVID-19 vaccine within 6 months prior to enrollment. * Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention. * Receipt of systemic immunosuppressants for \>14 days in total, within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study. * History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic. * Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection.

Inclusion Criteria

Exclusion Criteria

* ≥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:

* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.
* Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number.
* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* Receipt of the COVID-19 vaccine within 6 months prior to enrollment.
* Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.
* Receipt of systemic immunosuppressants for \>14 days in total, within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection.

Contacts and Locations

Study Contact

Moderna WeCare Team

CONTACT

+1-866-663-3762

WeCareClinicalTrials@modernatx.com

Study Locations (Sites)

DelRicht Research-Atlanta

Atlanta, Georgia, 30329

United States

DelRicht Research-Baton Rouge

Baton Rouge, Louisiana, 70769

United States

DelRicht Research-New Orleans

New Orleans, Louisiana, 70115

United States

DelRicht Research-Gulfport

Gulfport, Mississippi, 39503

United States

DelRicht Research-Tulsa

Tulsa, Oklahoma, 74133

United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-21

Study Completion Date2026-05-11

Study Record Updates

Study Start Date2025-07-21

Study Completion Date2026-05-11

Terms related to this study

Keywords Provided by Researchers

mRNA-1283
mRNA-1283 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Coronavirus Infections
Virus Diseases
mNEXSPIKE®
COVID-19
COVID-19 vaccine
Moderna

Additional Relevant MeSH Terms

COVID-19