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Virus Vaccine

mRNA-1273.214 Vaccine for Infant COVID-19 (BabyCOVE Trial)

Phase 2
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 64 (7 days after each vaccination)
Awards & highlights

BabyCOVE Trial Summary

This trial will assess the safety, effectiveness & tolerability of a COVID-19 vaccine in babies aged 3-6 months.

Who is the study for?
This trial is for healthy infants aged between 2 and <6 months who were born at or after 34 weeks gestation, with a minimum birth weight of 2.5 kg. They should not have received COVID-19 prophylaxis, have no known allergies to vaccine components, and must not be acutely ill or febrile before the study.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of mRNA-1273.214 SARS-CoV-2 vaccine in infants compared to a placebo. Infants will receive either the vaccine or placebo to determine how well it works and monitor any reactions.See study design
What are the potential side effects?
Possible side effects include typical reactions seen with vaccines such as pain at injection site, fever, fatigue, irritability, loss of appetite, and sleepiness. Severe allergic reactions are rare but possible.

BabyCOVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 64 (7 days after each vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 64 (7 days after each vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies Against Omicron Variant
Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
+2 more
Secondary outcome measures
GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1)
GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2)
GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2)
+2 more

BabyCOVE Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: mRNA-1273.214Experimental Treatment1 Intervention
Participants will receive 2 doses of mRNA-1273.214 by IM injection approximately 8 weeks apart (Day 1 and Day 57).
Group II: Part 1: mRNA-1273.214 Dose BExperimental Treatment1 Intervention
Participants will receive 2 doses of mRNA-1273.214 Dose B by IM injection approximately 8 weeks apart (Day 1 and Day 57).
Group III: Part 1: mRNA-1273.214 Dose AExperimental Treatment1 Intervention
Participants will receive 2 doses of mRNA-1273.214 Dose A by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).
Group IV: Part 2: PlaceboPlacebo Group1 Intervention
Participants will receive 2 doses of placebo by IM injection approximately 8 weeks apart (Day 1 and Day 57).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273.214
2021
Completed Phase 3
~20920

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,378,617 Total Patients Enrolled
37 Trials studying COVID-19
61,259,866 Patients Enrolled for COVID-19

Media Library

mRNA-1273.214 (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05584202 — Phase 2
COVID-19 Research Study Groups: Part 1: mRNA-1273.214 Dose A, Part 1: mRNA-1273.214 Dose B, Part 2: mRNA-1273.214, Part 2: Placebo
COVID-19 Clinical Trial 2023: mRNA-1273.214 Highlights & Side Effects. Trial Name: NCT05584202 — Phase 2
mRNA-1273.214 (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584202 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participating in this clinical research greater than 25 years?

"This medical research is seeking participants who are between 2 and 6 months of age."

Answered by AI

How many locations throughout the state are administering this clinical trial?

"Currently, this trial is welcoming participants from 8 separate medical centres. These locations include Doral, Syracuse and Richmond as well as other sites across the nation. To reduce travel difficulties for enrollees, it may be beneficial to choose a facility located nearby."

Answered by AI

Is there an opportunity for me to partake in this medical research?

"This medical trial is registering 700 infants aged between two months and six months, who have contracted covid-19. For eligibility in this study, participants must be 12 weeks of age or older but under 6 months at the time of initial dose administration. Applicants should additionally have been born with a gestational period that was 37+ weeks (for Part 1) or 34+ for Part 2 and their birth weight had to exceed 2.5 kilograms without any signs of fetal growth restriction. In addition, it's mandatory for parents/guardians to comprehend the protocol mandated follow up procedures as well as sign an informed consent form prior to enrollment."

Answered by AI

What is the aggregate number of subjects participating in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, first published on September 30th 2022, is presently enrolling participants. There is a requirement for 700 patients to be recruited from 8 distinct medical facilities."

Answered by AI

Has the administration approved Part 1: mRNA-1273.214 Dose B?

"As this is a Phase 2 trial, with some data supporting safety but no efficacy evidence yet, our team at Power have rated Part 1: mRNA-1273.214 Dose B as having an inherent safety of 2 on the scale from 1 to 3."

Answered by AI

Is enrollment for this investigation still open to the public?

"Affirmative, the data from clinicaltrials.gov reveals that this medical experiment is actively recruiting volunteers. The trial was made available to the public on September 30th 2022 and was last revised on October 21st 2022. In total, 700 participants need to be recruited across 8 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Texas
Other
California
What site did they apply to?
Be Well Clinical Studies
Madera Family Medical Group
Other
SeraCollection Research Services LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

What questions have other patients asked about this trial?

Do you offer transportation?
PatientReceived 1 prior treatment
~241 spots leftby Mar 2025