Recruiting

Observational Study

Sponsor:

Neuroganics LLC

Code:

NCT05095844

Conditions

COVID-19

Vaccine Adverse Reaction

Vaccine Reaction

Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use

Corona Virus Infection

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

vaccinated

Study Details

Brief summary:

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.

Conditions

COVID-19

Vaccine Adverse Reaction

Vaccine Reaction

Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use

Corona Virus Infection

Study ID

NCT05095844

Start date

Mar 15, 2022

Status verified date

Mar, 2022

Completion date

Apr 1, 2024

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

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.

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Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

Vaccinated

All individuals who have received a vaccine dose.

Interventions

vaccinated

Pfizer-BioNTech COVID-19 Vaccine, Moderna or J\&J/Janssen COVID-19 Vaccine, Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT) Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib) Hepatitis A (e.g., HAV) Hepatitis B (e.g., HBV) Human papillomavirus (e.g., HPV) Seasonal influenza (e.g., Flu) Measles (e.g., MMR) Mumps (e.g., MMR, MR, M) Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C) Pertussis (e.g., DTP, DTaP, Tdap) Pneumococcal conjugate (e.g., PCV) Polio (e.g., OPV or IPV) Rotavirus (e.g., RV) Rubella (e.g., MMR, MR, R) Tetanus (e.g., Td) Varicella (e.g., VAR)

Primary outcome measure

  • Adverse Event [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Neuroganics LLC

Recruiting

Northglenn, Colorado, United States, 80265

Contacts

Donald C Cooper, Ph.D.

vaccinestudy@protonmail.com

Principal Investigator:

Donald C Cooper, Ph.D.

More Information

Sponsor

Neuroganics LLC

Last update posted

Mar 18, 2022

Last verified

Mar, 2022

Keywords

  • COVID-19
  • coronavirus
  • vaccine
  • influenza
  • injury
  • compensation
  • Pfizer
  • Moderna
  • BioNTech
  • Johnson and Johnson
  • Comirnaty
  • Flu Vaccination
  • Quadrivalent
  • Flucelvax
  • Flu Shots
  • Afluria Quadrivalent (Seqirus)
  • Fluarix
  • FluLaval
  • Fluzone
  • Walgreens
  • CVS
  • Pharmacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuroganics LLC on 2022-03-18.