mRNA-1273.214 for Coronavirus Disease 2019 (COVID‑19)
Phase-Based Progress Estimates
Effectiveness
Safety
Sera Collection Research Services, Montebello, CA
Coronavirus Disease 2019 (COVID‑19)
mRNA-1273.214 - BiologicalEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to <6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2).
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Other trials for Coronavirus Disease 2019 (COVID‑19)
Study Objectives
10 Primary · 2 Secondary · Reporting Duration: Day 57; Part 2: BD-Day 29
BD-Day 29
GM of the Serum Ab Level Post BD (Omicron)
SRR of Vaccine Recipients Post BD (Omicron)
Day 57
SRR of Vaccine Recipients of SARS-CoV-2 VOC (Omicron and Original Strain)
Day 57
Geometric Mean (GM) of the Serum Antibody (Ab) Level (Omicron)
Seroresponse Rate (SRR) of Vaccine Recipients (Omicron)
Day 57
GM of the Serum Ab Level of SARS-CoV-2 VOC (Omicron and Original Strain)
Day 29
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 575
Number of Participants with AEs Leading to Withdrawal
Number of Participants with Adverse Events of Special Interest (AESI)
Number of Participants with Medically-Attended AEs (MAAEs)
Number of Participants with Serious AEs (SAEs)
Day 8
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Other trials for Coronavirus Disease 2019 (COVID‑19)
Trial Design
1 Treatment Group
mRNA-1273.214
1 of 1
Experimental Treatment
960 Total Participants · 1 Treatment Group
Primary Treatment: mRNA-1273.214 · No Placebo Group · Phase 3
mRNA-1273.214
Biological
Experimental Group · 1 Intervention: mRNA-1273.214 · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 57; part 2: bd-day 29
Closest Location: Sera Collection Research Services · Montebello, CA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Coronavirus Disease 2019 (COVID‑19)
0 CompletedClinical Trials
Eligibility Criteria
Age < 18 · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Parent(s)/LAR(s) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures and provide written informed consent
You are 2 years or older and have a BMI at or above the 3rd percentile according to WHO Child Growth Standards at the Screening Visit.
You are born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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