COVID-19 Clinical Trial
— NVAERSOfficial title:
National Vaccine Adverse Event Reporting Survey to Determine the Etiology of Vaccine-Induced Injury
NCT number | NCT05095844 |
Other study ID # | NVAERS_1121 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2022 |
Est. completion date | April 1, 2024 |
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms. The primary goal of this study is to create a national database and gather vaccine-associated serious adverse events/injury data from newly vaccinated individuals in the US in order to identify the possible underlying causal relationships and plausible underlying biological mechanisms. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration. The secondary goal is to establish criteria that enable classification of vaccine-induced adverse events/injuries compare data from our database with the official Vaccine Injury Table National Vaccine Injury Compensation Program on or after March 21, 2017. The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
Status | Recruiting |
Enrollment | 100000 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 99 Years |
Eligibility | Inclusion Criteria: Individuals who have received at least one vaccine dose of ANY of the following vaccines (below) and experienced adverse reaction within 60 days of vaccine administration: 1. Pfizer-BioNTech COVID-19 Vaccine 2. Moderna COVID-19 Vaccine 3. J&J/Janssen COVID-19 Vaccine 4. Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT) 5. Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib) 6. Hepatitis A (e.g., HAV) 7. Hepatitis B (e.g., HBV) 8. Human papillomavirus (e.g., HPV) 9. Seasonal influenza (e.g., Flu) 10. Measles (e.g., MMR) 11. Mumps (e.g., MMR, MR, M) 12. Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C) 13. Pertussis (e.g., DTP, DTaP, Tdap) 14. Pneumococcal conjugate (e.g., PCV) 15. Polio (e.g., OPV or IPV) 16. Rotavirus (e.g., RV) 17. Rubella (e.g., MMR, MR, R) 18. Tetanus (e.g., Td) 19. Varicella (e.g., VAR). Exclusion Criteria: 1. Non citizens or permanent residents of the US 2. Individuals who have not received at least one vaccine dose in the past 3 years. 3. Individuals whose vaccine was administered more than 60 days before symptoms of the serious adverse event. - |
Country | Name | City | State |
---|---|---|---|
United States | Neuroganics LLC | Northglenn | Colorado |
Lead Sponsor | Collaborator |
---|---|
Neuroganics LLC | Ramos Injury Law Firm |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Event | Reported adverse event occurring less than 60 days after administration of vaccine. | 2 years | |
Secondary | Vaccine manufacturer efficacy | Comparison of multiple vaccine manufacturers for adverse events. | 2 years |
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