Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVI… (NCT05584202) | Clinical Trial Compass
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 range
2 Months – 6 Months
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
3
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)
4
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation