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Immunity Against COVID-19 and Safety Following Evusheld (Long-acting Antibody) in Immunocompromised Children and Adolescents

Phase 4
Completed
Conditions
Immunocompromised Children and Adolescents
Evusheld
Registration Number
TCTR20230406002
Lead Sponsor
Faculty of Medicine Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
70
Inclusion Criteria

1. Males or females 5 - < 18 years of age and weights more than or equal 20 kg(s).
2. Participants in a research with immune deficiency and symptoms were stable, classified as malignant or non-malignant.
3. Participants or guardian of participant understand(s) Thai language through speaking, reading and writing
4. Participants or guardian of participant be able
to communicate through electronic tools such as Google form or line.
5. Capable of attending all study visits according to the study schedule.
6. Capable of informed assent/consent and provision of written informed consent before any study procedures

Exclusion Criteria

1. Have history of severe drug or vaccine allergy (anaphylaxis)?
2. Have history allergic to the components of the
drug?
3. Participant has an infection or who has the
history of COVID-19 infection within the last 90 days? or who has at higher risk of getting COVID-19
infection.
4. Did not receive any vaccine COVID-19 within 12
weeks before the enrollment?
5. Have any symptoms of acute illness within 3 days
before the enrollment?
6. Be pregnant?

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Immunological Response 4, 12 and 24 weeks after Evusheld injection IgG level
Secondary Outcome Measures
NameTimeMethod
Immunological Response 4 week after Evusheld injection Neutralizing antibody assay,Safety 7 days after injection Adverse effects
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