Immunocompromised Children and Adolescents Immunocompromised Children and Adolescents Evusheld
Conditions
Interventions
tixagevimab/cilgavimab 150/150 mg ,tixagevimab/cilgavimab 300/300 mg
Active Comparator Drug,Active Comparator Drug
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
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
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?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological Response 4, 12 and 24 weeks after Evusheld injection IgG level | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological Response 4 week after Evusheld injection Neutralizing antibody assay,Safety 7 days after injection Adverse effects | — |
Countries
Thailand
Contacts
Public ContactAssoc. Prof. Jassada Buaboonnam
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed