Monitoring response on COVID-19 vaccination in children with cancer

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003388-90-NL

Enrollment

130

Registered

2021-06-21

Start date

2021-07-05

Completion date

Unknown

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with cancer, receiving COVID-19 vaccination

Interventions

Trade Name: Comirnaty COVID-19 mRNA Vaccine (nucleosie modified) Pharmaceutical Form: Concentrate for dispersion for injection Trade Name: COVID-19 Vaccine Moderna Pharmaceutical Form: Dispersion for

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancer as compared to healthy children;Secondary Objective: To assess in children with cancer after SARS-CoV-2 vaccination: -durability of the antibody response -SARS-CoV-2 specific T and B cell response -the contribution of a 3rd vaccination ;Primary end point(s): The primary study parameter is the antibody based immune response to vaccination 28 days (t=3) after the second vaccination compared to controls. Participants will be classified as responders or non-responders;Timepoint(s) of evaluation of this end point: 28 days after second vaccination (t=3)	—

Measure

Time frame

Main Objective: To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancer as compared to healthy children;Secondary Objective: To assess in children with cancer after SARS-CoV-2 vaccination: -durability of the antibody response -SARS-CoV-2 specific T and B cell response -the contribution of a 3rd vaccination ;Primary end point(s): The primary study parameter is the antibody based immune response to vaccination 28 days (t=3) after the second vaccination compared to controls. Participants will be classified as responders or non-responders;Timepoint(s) of evaluation of this end point: 28 days after second vaccination (t=3)

—

Secondary

Measure	Time frame
Secondary end point(s): -Longevity of SARS-CoV-2 specific antibodies -SARS-CoV-2 specific T-cell response -Additional effect of a 3rd vaccination by measuring antibody based immune response;Timepoint(s) of evaluation of this end point: -21-28 days after vaccination 1 (t=2) -21-28 days after vaccination 2 (t=3) -21-28 days after vaccination 3 (t=4) -12 months after vaccination (t=5)	—

Countries

Netherlands

Contacts

Public ContactProf. Dr. W.J.E. Tissing

Princess Máxima Center for Pediatric Oncology

trialmanagement@prinsesmaximacentrum.nl003188972 72 72

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026