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COVID-19 Vaccine for Children (COVID-19 Trial)
COVID-19 Trial Summary
This trial will test how safe and effective a new vaccine is for children. It will start with the oldest age group (6-12 years old) and move down to the youngest (6-24 months old).
COVID-19 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOVID-19 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COVID-19 Trial Design
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Who is running the clinical trial?
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- My child's vital signs are normal for their age, sex, weight, and height.I haven't had any vaccines in the last 14 days and won't get any before Day 49, except for the flu shot.I have been on chemotherapy for cancer within the last year.My child was born full-term, weighing at least 2.5 kg and is between 6 to 12 months old.I have received or will receive a COVID-19 vaccine during the study.I have not received immunoglobulin or blood products in the last 90 days.I am a child between 6 months and 12 years old and considered healthy or stable.I haven't had major changes in my health or medications in the last 2 months.I have been diagnosed with MIS-C before or currently.I have an immune system disorder or have been on drugs that weaken my immune system.I am taking medication to prevent or treat COVID-19.My child is between 6 months and 12 years old and is healthy or stable according to the doctor.You have been diagnosed with COVID-19 in the past.I have had myocarditis or pericarditis in the past.I do not have a fever or any acute illness today.I, and if applicable, my caregiver, agree to participate and follow the study's requirements.My child was born full-term and weighed at least 2.5 kg.
- Group 1: Originally Randomized to Vaccine, Delayed Booster Group
- Group 2: Originally Randomized to Vaccine, Immediate Booster Group
- Group 3: Originally Randomized to 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
How many distinct facilities are overseeing this clinical trial?
"There are 42 different locations at which this trial is accepting patients, three of which are MedPharmics in Lafayette, Louisiana, Wee Care Pediatrics - Roy in Roy, Utah, and PanAmerican Clinical Research in Brownsville, Texas."
Are there vacancies in this experiment for test subjects?
"That is correct. The information on clinicaltrials.gov does show that the study is still recruiting patients. This trial was originally posted on 7/22/2022 and was most recently edited on 10/14/2022. 3600 patients are needed for this study, which will be conducted at 39 different locations."
Does this research require participants to be of a certain age?
"The age bracket that this trial is recruiting from are those who have not yet turned 12, and are at least 6 months old."
How many patients will be enrolled in this clinical trial?
"The clinical trial is still actively recruiting patients, as of 10/14/2022. According to the original posting on clinicaltrials.gov from 7/22/2022, 3600 participants are needed for the study which will be taking place at 39 locations."
By the end of this research, what do scientists hope to have accomplished?
"The primary outcome of this study will be the incidence and severity of medically attended adverse events (MAAEs) over a period of 730 days. Secondary outcomes include the incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19, the incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19, and antibodies to SARS-CoV-2 nucleoprotein at specified time points."
Who meets the requirements to take part in this clinical trial?
"This clinical trial is looking for 3600 participants aged between 6 months and 11 years who currently have covid-19. The following additional criteria must be met: Pediatric participants 6 months to < 12 years of age at randomization, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within normal range prior to the first vaccination, according to the child's age, sex, and height., Participant and parent(s)/caregiver(s) or legally"
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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