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mRNA-1273.214 Vaccine for Infant COVID-19 (BabyCOVE Trial)
BabyCOVE Trial Summary
This trial will assess the safety, effectiveness & tolerability of a COVID-19 vaccine in babies aged 3-6 months.
BabyCOVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BabyCOVE Trial Design
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- If you have a long-term medical condition like acid reflux, it needs to be under control and stable to participate in Part 2 of the study.I am between 12 weeks and 6 months old.I am a healthy infant between 2 and 6 months old.I have had COVID-19 or been in close contact with someone who has, within the last 2 weeks.I haven't had any vaccines 14 days before or plan to within 14 days after the study vaccine.I am a healthy infant between 2 and 6 months old.I have received blood products through an IV or injection in the last 3 months.I have not used immune-suppressing drugs for more than 14 days in the last 6 months.I have received a COVID-19 vaccine before.I was born full-term or nearly full-term with a normal birth weight and my current height and weight are within the normal range for my age.I was born full-term or nearly full-term with a normal birth weight and my current height and weight are within the normal range for my age.The parent(s)/legal guardian is capable of understanding and willing to follow the study procedures and provide written consent.I am between 12 weeks and 6 months old.
- Group 1: Part 1: mRNA-1273.214 Dose A
- Group 2: Part 1: mRNA-1273.214 Dose B
- Group 3: Part 2: mRNA-1273.214
- Group 4: Part 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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