Implementation RSV Immunization Study (IRIS)

Conditions

Healthy infants receiving an RSV immunization to prevent for serious diseases due to an RSV infection

Brief summary

RSV-specific antibody levels at 12 months post-nirsevimab immunization in the nirsevimab group and the control group (at 12-15 months of age)

Detailed description

RSV-specific serum IgA levels pre- and 2, 4, 6, 12 months post-nirsevimab immunization and in the control group, RSV-specific serum antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization, RSV-specific serum antibody concentration pre- and 2, 4, 6 and 12 months postnirsevimab immunization / Questionnaire data such as age and weight of immunization, RSV-specific antibody neutralization and Fc-functionality at 12 months post immunization in the nirsevimab group and the control group, RSV-specific monoclonal and maternal antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBeyfortus 100 mg solution for injection in pre-filled syringe

DRUGBeyfortus 50 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
RSV-specific antibody levels at 12 months post-nirsevimab immunization in the nirsevimab group and the control group (at 12-15 months of age)	—

Secondary

Measure	Time frame
RSV-specific serum IgA levels pre- and 2, 4, 6, 12 months post-nirsevimab immunization and in the control group, RSV-specific serum antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization, RSV-specific serum antibody concentration pre- and 2, 4, 6 and 12 months postnirsevimab immunization / Questionnaire data such as age and weight of immunization, RSV-specific antibody neutralization and Fc-functionality at 12 months post immunization in the nirsevimab group and the control group, RSV-specific monoclonal and maternal antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization	—

Measure

Time frame

RSV-specific serum IgA levels pre- and 2, 4, 6, 12 months post-nirsevimab immunization and in the control group, RSV-specific serum antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization, RSV-specific serum antibody concentration pre- and 2, 4, 6 and 12 months postnirsevimab immunization / Questionnaire data such as age and weight of immunization, RSV-specific antibody neutralization and Fc-functionality at 12 months post immunization in the nirsevimab group and the control group, RSV-specific monoclonal and maternal antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization

—

Countries

Netherlands

Outcome results

None listed