Status:
UNKNOWN
Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents
Lead Sponsor:
Federal University of Espirito Santo
Collaborating Sponsors:
Centro de Pesquisas René Rachou
Butantan Institute
Conditions:
COVID-19
Eligibility:
All Genders
3-49 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.
Detailed Description
Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162...
Eligibility Criteria
Inclusion
- Age between 3 and 17 years old (VACC and BNTC groups)
- Age between 18 and 49 years old (ADU group)
Exclusion
- Pregnant teenagers;
- History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine;
- Have previously received a vaccine against COVID-19;
- Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C);
- Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 21 2023
Estimated Enrollment :
1120 Patients enrolled
Trial Details
Trial ID
NCT05225285
Start Date
January 21 2022
End Date
March 21 2023
Last Update
February 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Valéria Valim
Vitória, Espírito Santo, Brazil, 29041-295