A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age

Part of paid clinical trials in Ontario, California.

Sponsor
ModernaTX, Inc.
Study ID
NCT07808697
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 11 Years
Healthy Volunteers
Accepted

Interventions

  • mRNA-1283 — BIOLOGICAL
    Sterile liquid for injection
  • mRNA-1273 — BIOLOGICAL
    Sterile liquid for injection

Study Details

This study will evaluate 2 dose levels of mRNA-1283 in participants ≥6 months to \<12 years to determine the optimal dose level per age group.

Key Dates

First listed
Sep 9, 2026
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Aug 30, 2029
Completion
Aug 30, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cohort 1: mRNA-1283 Dose Level 1
    Participants aged 2 to \<12 years receive one IM dose of on Day 1.
  • Experimental: Cohort 1: mRNA-1283 Dose Level 2
    Participants aged 2 to \<12 years receive one IM dose of on Day 1.
  • Active Comparator: Cohort 1: mRNA-1273
    Participants aged 2 to \<12 years receive one IM dose of on Day 1.
  • Experimental: Cohort 2: mRNA-1283 Dose Level 1
    Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Days 1 and 29).
  • Experimental: Cohort 2: mRNA-1283 Dose Level 2
    Participants aged 6 months to \<2 years receive two IM doses of 28 days apart (Days 1 and 29).
  • Active Comparator: Cohort 2: mRNA-1273
    Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Day 1 and 29).

Primary Outcome Measure

Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Day 1 through Day 7; 7 Days following injection ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Orange County Research CenterOntarioCalifornia91762-
Hope Research NetworkMiamiFlorida33166-
Spotlight Research Center - Internal MedicineMiamiFlorida33167-
Indago Research and Health CenMiami LakesFlorida33016-
MplusM - D&H Tamarac Research CenterTamaracFlorida33321-
Eagle Clinical Research, LLCChicagoIllinois60621-
Great Lakes Research Institute -SouthfieldSouthfieldMichigan48075-
Senders PediatricsSouth EuclidOhio44121-
REX Clinical TrialsBeaumontTexas77701-
PanAmerican Clinical Research, LLC.BrownsvilleTexas78520-
South Ogden Family MedicineSouth OgdenUtah84403-
Clinical Research PartnersRichmondVirginia23226-
Childrens Hospital Regional Medical CenterSeattleWashington98105-

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Orange County Research Center· Ontario, CAHope Research Network· Miami, FLSpotlight Research Center - Internal Medicine· Miami, FLIndago Research and Health Cen· Miami Lakes, FLMplusM - D&H Tamarac Research Center· Tamarac, FLEagle Clinical Research, LLC· Chicago, IL

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