TerminatedPhase 2

Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants

Stopped: The trial was terminated because data from the dose finding part of the trial did not support further evaluation of effectiveness of mRNA-1273. There were no safety concerns.

United States68 participantsStarted 2022-09-30

Plain-language summary

The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to \< 6 months.

Who can participate

Age range2 Months – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be at least 12 weeks completed age and must not have completed 6 months at the time of administration of first dose.
✓. If the participant has a chronic, stable disease, they may be eligible to enroll in Part 2, but ineligible for Part 1. The chronic condition (for example, gastroesophageal reflux disease) should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion in Part 2.

Exclusion criteria

✕. Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to first or second vaccination or plans to receive such a vaccine within 14 days of any study vaccination.
✕. Systemic immunosuppressants or immune-modifying drugs (including maternal use during pregnancy or lactation) for \>14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥ 1 milligrams (mg)/kg/day or, if participant weighs \>10 kg: ≥10 mg/day prednisone equivalent). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.
✕. Intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to enrollment.

What they're measuring

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Injection

Timeframe: Day 1 up to 7 days after first vaccination (up to Day 8)

Number of Participants With Solicited Local and Systemic ARs After Second Injection

Timeframe: Day 57 up to 7 days after second vaccination (up to Day 64)

Number of Participants With Unsolicited Adverse Events (AEs) After Any Injection

Timeframe: Day 1 up to 28 days after any vaccination (up to Day 85)

Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation

Timeframe: Day 1 up to Day 422

Trial details

NCT IDNCT05584202

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

Results submitted2025-11-14

View on ClinicalTrials.gov More SARS-CoV-2 trials