Healthy volunteers (paediatric subjects) with prior SARS-CoV-2 infection MedDRA version: 23.1 Level: LLT Classification code 10084464 Term: COVID-19 immunization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Comirnaty original
Pharmaceutical Form: Concentrate for dispersion for injection
Trade Name: Comirnaty Original/Omicron BA.4-5
Pharmaceutical Form: Concentrate for dispersion for injectio
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =5 years to =11 years of age on day of signing the informed consent form. 2. In good health or stable clinical condition. 3. Legally Acceptable Representative (LAR) has reviewed the subject information and signed the informed consent form on behalf of the subject and the subject has expressed willingness to participate Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has previously received any investigational or licensed COVID-19 vaccine. 2. Has known congenital or acquired immune disorder or immunodeficiency that may interfere with vaccine response e.g. known infection with human immunodeficiency virus (HIV) with low CD4 count or other immunosuppression at time of signing informed consent form. 3. Has a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention (including systemic glucocorticoids), or findings that may have a significant effect on the target endpoints and which may therefore mask or inhibit the therapeutic effect under investigation as judged by the investigator. 4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection or venepuncture. 5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 6. Receipt of medications intended to prevent COVID-19, in case of such medications receiving approval in this age group during the trial. 7. Uses drugs with significant interaction with the investigational product or has any contraindications as per the Summary of Product Characteristics. 8. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the subject inappropriate for the study. 9. Has any kind of dependency on the principal investigator or member of the study team or LAR is employed by the principal investigator or within the same department as the PI or study team at the institution where the study is executed. 10. Is unable to report solicited adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the humoral immune response of a single compared to a two dose COVID-19 vaccination regimen is non-inferior in paediatric subjects who are immunologically primed by natural infection.;Secondary Objective: 1. To assess the safety and reactogenicity profile of a single dose COVID-19 vaccine regimen against SARS-CoV-2 in paediatric subjects with a history of prior SARS-CoV-2 infection, compared to the two dose regimen. 2. To assess the medium (6 months) and long term (12 month) humoral immune response of the single COVID-19 vaccine dosing regimen against wild-type SARS-CoV-2 in paediatric subjects with a history of prior SARS-CoV-2 infection. 3. To assess the short (28 days), medium and long term humoral immune response of the single dose COVID-19 vaccine regimen against SARS-CoV-2 variants of concern (VoCs) in paediatric subjects with a history of prior SARS-CoV-2 infection.;Primary end point(s): The geometric mean ratio of neutralizing titers against wild type virus (Virus Neutralization Assay) at day 28 after completion of the control versus the intervention regimen of the vaccine.;Timepoint(s) of evaluation of this end point: as specified in the endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: - The percentage of subjects reporting at least one solicited systemic adverse events Grade = 2 (AEs) in the 7 days after any vaccine dose, as measure of systemic reactogenicity. - The percentage of subjects reporting solicited local and systemic adverse events (AEs) for 7 days after each vaccine dose. - The percentage of subjects reporting unsolicited AEs for 14 days after each vaccine dose. - The percentage of subjects reporting serious adverse events (SAEs) Grade = 3 on the Common Toxicity Criteria or Adverse Events of Special interest (AESI) until 12 months post-vaccination. Immunogenicity: - Neutralizing titers against wild type virus (Virus Neutralization Assay) at 6 and 12 months postvaccination. - Quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA) at 28 days, 6 months and 12 months post-vaccination. - Geometric Mean Fold Ratio in SARS-CoV-2 serum anti-RBD antibody titer from before vaccination to each subsequent time points at 1, 6 and 12 months post-vaccination. - Neutralizing titers against variants of concern (Virus Neutralization Assay) at day 28 and 6 months post-vaccination.;Timepoint(s) of evaluation of this end point: as specified in the endpoints | — |
Countries
Germany, Greece, Netherlands, Norway, Sweden
Contacts
Public ContactEUPG, CoVacc Study Team
University Medical Center Utrecht
Outcome results
None listed