RBR-5y9y7p7
Recruiting
Phase 4
Safety and Immunogenicity of heterologous or homologous booster after complete vaccination against COVID-19.
Secretaria Municipal de Saúde do Rio de Janeiro0 sitesDecember 13, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Secretaria Municipal de Saúde do Rio de Janeiro
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older;
- •Have completed the primary vaccination course against COVID\-19 with the Coronavac/Butantan, AstraZeneca/Fiocruz or Pfizer vaccines for at least three months;
- •Accepting to participate in the study by signing the Informed Consent Form (ICF);
Exclusion Criteria
- •Uncontrolled chronic illness (defined as illness that required a significant change in therapy or hospitalization for worsening illness during the 3 months prior to inclusion);
- •Individuals with any severe or progressive neurological disorder, difficult to control seizure disorder or a history of Guillian\-Barré syndrome or demyelinating diseases of the central nervous system;
- •Individuals with congenital or acquired immunodeficiency\*; or individuals who have received treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g. eg, for cancer or an autoimmune disease, within the last 12 months or planned receipt during the study period. If a short\-term course (\< 14 days) of systemic corticosteroids has been for the treatment of an acute illness, participants should not be included in the study until corticosteroid therapy has been discontinued for at least 30 days prior to the study. A single dose of systemic steroids in a single day is allowed, as well as inhaled/nebulized, intra\-articular, intrabursal or topical (skin or eyes) corticosteroids are allowed;
- •Participants who report pregnancy in progress or planning to become pregnant within the next 60 days after inclusion in the study; and postpartum women (up to 45 days after delivery). In the case of women of childbearing age, with an active sexual life and without consistent use of contraceptives, at the researcher's discretion, the participant may be excluded or, alternatively, included, if she agrees to use contraceptives for a period of 60 days after inclusion . In these cases, if necessary, the contraceptive will be provided by the responsible researcher free of charge;
- •Blood transfusion or use of blood products in the last 6 months;
- •Having had a heterologous primary vaccination schedule against Covid\-19;
- •Have received a higher number of doses than currently recommended for Covid\-19;
- •Having had a serious adverse event to any formulation of the Covid\-19 vaccine;
- •Hypersensitivity to the active ingredient or to any of the excipients of the Covid\-19 vaccines used in the study;
- •Any condition that, in the investigator's opinion, could compromise the follow\-up of the study.
Outcomes
Primary Outcomes
Not specified
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