Who We Are
The UCSD MCAP provides comprehensive, family centered care of women, children, youth and families. This internationally recognized multidisciplinary specialist provides medical care, clinical research trials, patient education, counseling, case management, peer advocacy, and community education. Its team of investigators is highly experienced in vaccine clinical trials with an emphasis on the prevention of respiratory viral diseases.
Moderna Pediatric COVID-19 Vaccine Study Survey
To Conduct Phase 2 and Phase 3 Efficacy Trials to prevent infection and COVID-19 disease.
Protocol Title: A Phase 2/3, Two-Part, Open-Label, Dose Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 months to < 12 Years of Age
- 6 years to < 12 years
- 2 years to < 6 years
- 6 months to < 2 years
The study will be conducted in 2 Parts
- Part 1: open label, dose determining; n= 750 (150 6 years to <12 years; 150 2 years to <6 years; and 450 6 months to <2 years) )
- Part 2: is blinded; n=6000 (2,000 in each age group), 3:1 (mRNA 1273 vaccine:placebo) randomization (mRNA 1273 dose used per cohort in Part 2 is determined by Part 1)
Note: All children at the end of the study will receive the optimal vaccine for age
Children to be included in the study are
- Male or female, 6 months to < 12 years of age at the time of consent and in good health. based on review of medical history and screening physical examination.
- Children with chronic conditions (eg, overweight, asthma, diabetes, cystic fibrosis, HIV) in stable will be eligible for inclusion.
- Parent/legal guardian agrees to have child participate and provides written informed consent.
- Children 6 months to <2 years born at >37 weeks with a minimum weight of 2.5 kilograms
- Children with immunosuppressive conditions or receiving immunosuppressive medications will not be eligible to participate in the study
What Study Volunteers Can Expect
- When a potential parent/legal guardian contacts us, they will be provided information about the research study.
- Parent/legal guardian of a potential participant will be asked personal questions about their child before coming into the study clinic to help determine their potential for study eligibility. Determining eligibility can include things like asking about their medical history and doing a physical exam.
- You will be provided information about the study to enable people to make an informed decision about whether or not to have their child join the study. Specific details about the study will be provided during the informed consent process.
During the study:
- The study will require coming into the study clinic for 7 or more visits over 1-2 years.
- The study will involve your child getting 2 injections of vaccine or placebo and having blood drawn at some visits.
- Parent/Legal guardian of participants will be asked to keep track of how their child is feeling using an online diary for about a week following each injection.
- Study participants are compensated for their time, travel, and inconvenience while enrolled in the study.
After the study:
- We may ask if we can contact participants again for another study.
- When the study is complete, the results will be disseminated to all families and their communities without any identifying information