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Trial - NCT05225285


Column Value
Trial registration number NCT05225285
Full text link
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05225285

First author
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Valéria Valim

Contact
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

val.valim@gmail.com

Registration date
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

2022-02-04

Recruitment status
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age between 3 and 17 years old (vacc and bntc groups) age between 18 and 49 years old (adu group)

Exclusion criteria
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

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).

Number of arms
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Federal University of Espirito Santo

Inclusion age min
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

3

Inclusion age max
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

49

Countries
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

1120

primary outcome
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Antigen-specific stimulation of peripheral blood mononuclear cells in vitro;B lymphocytes;Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S);Dosage of systemic soluble factors;intracytoplasmic cytokines;Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2;T lymphocytes;Viral neutralization assay

Notes
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2;4 weeks apart (3-17 years old)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;4 weeks apart (3-17 years old)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;4 weeks apart (18-49 years old)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]