Who We Are
The UCSD MCAP offers complete, household centered care of ladies, youngsters, youth and households. This internationally acknowledged multidisciplinary specialist offers medical care, medical analysis trials, affected person schooling, counseling, case administration, peer advocacy, and group schooling. Its staff of investigators is very skilled in vaccine medical trials with an emphasis on the prevention of respiratory viral ailments.
To Conduct Section 2 and Section 3 Efficacy Trials to stop an infection and COVID-19 illness.
Protocol Title: A Section 2/3, Two-Half, Open-Label, Dose Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Managed Growth Research to Consider the Security, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Wholesome Youngsters 6 months to < 12 Years of Age
- 6 years to < 12 years
- 2 years to < 6 years
- 6 months to < 2 years
The research shall be carried out in 2 Elements
- Half 1: open label, dose figuring out; n= 750 (150 6 years to <12 years; 150 2 years to <6 years; and 450 6 months to <2 years) )
- Half 2: is blinded; n=6000 (2,000 in every age group), 3:1 (mRNA 1273 vaccine:placebo) randomization (mRNA 1273 dose used per cohort in Half 2 is set by Half 1)
Notice: All youngsters on the finish of the research will obtain the optimum vaccine for age
Youngsters to be included within the research are
- Male or feminine, 6 months to < 12 years of age on the time of consent and in good well being. based mostly on assessment of medical historical past and screening bodily examination.
- Youngsters with continual situations (eg, obese, bronchial asthma, diabetes, cystic fibrosis, HIV) in secure shall be eligible for inclusion.
- Mum or dad/authorized guardian agrees to have youngster take part and offers written knowledgeable consent.
- Youngsters 6 months to <2 years born at >37 weeks with a minimal weight of two.5 kilograms
- Youngsters with immunosuppressive situations or receiving immunosuppressive drugs won’t be eligible to take part within the research
What Research Volunteers Can Anticipate
Earlier than becoming a member of:
- When a possible mother or father/authorized guardian contacts us, they are going to be offered details about the analysis research.
- Mum or dad/authorized guardian of a possible participant shall be requested private questions on their youngster earlier than coming into the research clinic to assist decide their potential for research eligibility. Figuring out eligibility can embody issues like asking about their medical historical past and doing a bodily examination.
- You can be offered details about the research to allow folks to make an knowledgeable determination about whether or not or to not have their youngster be part of the research. Particular particulars in regards to the research shall be offered throughout the knowledgeable consent course of.
In the course of the research:
- The research would require coming into the research clinic for 7 or extra visits over 1-2 years.
- The research will contain your youngster getting 2 injections of vaccine or placebo and having blood drawn at some visits.
- Mum or dad/Authorized guardian of individuals shall be requested to maintain monitor of how their youngster is feeling utilizing an internet diary for a few week following every injection.
- Research individuals are compensated for his or her time, journey, and inconvenience whereas enrolled within the research.
After the research:
- We could ask if we will contact individuals once more for an additional research.
- When the research is full, the outcomes shall be disseminated to all households and their communities with none figuring out data