Purpose

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and an optional booster dose (in Parts 1 and 2).

Condition

Eligibility

Eligible Ages
Between 6 Months and 11 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment. - Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow up, including all procedures, written informed consent is provided, and participants provide assent. - For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit. - For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg). - For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29) and the third dose in Part 3 (Day 149/booster dose Day 1), and not currently breastfeeding.

Exclusion Criteria

  • Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to administration of vaccine. - Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine. - Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment. - Known hypersensitivity to a component of the vaccine or its excipients. - A medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. - History of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. - Received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) - Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1 - Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Parts 1 and 3 are Open-label; Part 2 Randomized and Observer-blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mRNA-1273
Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at doses pre-specified for this study, 28 days apart, on Days 1 and 29. Part 1 participants will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for each age group, at least 6 months after Dose 2. Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1, 28 days apart, on Days 1 and 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for this age group, at least 6 months after Dose 2. Part 3: Participants will receive 2 IM injections of mRNA-1273 approximately 28 days apart (on Days 1 and 29) as the primary series followed by 1 IM injection as a third dose (on Day 149) at least 3 months after receipt of the second dose of the primary series. All 3 injections will be administered at the low dose that participants received during Part 1.
  • Biological: mRNA-1273
    Sterile liquid for injection
Placebo Comparator
Placebo
Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2.
  • Biological: mRNA-1273
    Sterile liquid for injection
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection

Recruiting Locations

More Details

Status
Recruiting
Sponsor
ModernaTX, Inc.

Study Contact

Moderna Clinical Trials Support Center
1-877-777-7187
clinicaltrials@modernatx.com

Detailed Description

This is a Phase 2/3, 3-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years. Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.