Prospective monitoring of immune response following COVID-19 vaccination in children with cancer

Phase 4

Completed

• Conditions: 10027655; 10047438; Corona vaccination; immune response; 10027665

• Registration Number: NL-OMON52106
• Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-04-29
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

-Willing to receive routine COVID-19 vaccination with Pfizer or Moderna vaccine
as part of the national vaccination program (cohort I)
-Having received SARS-CoV-2 vaccination with Pfizer or Moderna as part of the
national vaccination program, with the last vaccination less than 6 weeks
before study entry (Cohort II + cohort III + cohort IV)
-Written informed consent

Exclusion Criteria

-History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (e.g. anaphylaxis) to any component of the study
intervention(s).
-Not able to give informed consent (eg language problem, illiteracy)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the antibody based immune response to<br /><br>vaccination against COVID-19 28 days (t=3) after the second vaccination as<br /><br>compared to a control cohort.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Titers of SARS-CoV-2 specific antibodies at 12 months after the second<br /><br>vaccination<br /><br>-SARS-CoV2 specific T cell response measured at baseline, 21-28 days after<br /><br>first vaccination and at 28 days after the second vaccination</p><br>