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Implementation RSV Immunization Study (IRIS)
EU CTIS ID: 2025-521801-42-00
What this study is testing
Determine the effect of nirsevimab immunization on the development of the infant’s own humoral immune response (antibody levels) after an RSV infection
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Nirsevimab group: Infants and newborns born before or at the beginning of the RSV season and are 0-4 months of age by immunization
- Control group: Children around 12-15 months of age at the start of the RSV season (September/October)
- Nirsevimab group: Infants eligible for the nirsevimab immunization and the parents/ legal representatives decided that the infants will receive the nirsevimab immunization
- Children have to be healthy according to the same health criteria applied in the well baby clinic when a child is immunized, e.g. also infants with small increases in body temperature or a cold are seen as children with normal health
- The parents/ legal representatives accept participation of their (unborn) child in the study according to the described procedures
- Presence of a signed informed consent (the parents/legal representatives have given written informed consent after receiving oral and written information)
You likely can't join if
- Nirsevimab group: Having received nirsevimab immunization before study entry
- Known or suspected serious underlying medical condition that can interfere with the results of the study. Such as, but not limited to, certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease, seizure disorder or cancer.
- Control group: Having received nirsevimab immunization
- Control group: Being hospitalized due to a confirmed RSV infection
- The biological mother received an RSV vaccination during pregnancy
- Nirsevimab group: Confirmed RSV infection before study entry
See the full eligibility criteria
- Nirsevimab group: Infants and newborns born before or at the beginning of the RSV season and are 0-4 months of age by immunization
- Control group: Children around 12-15 months of age at the start of the RSV season (September/October)
- Nirsevimab group: Infants eligible for the nirsevimab immunization and the parents/ legal representatives decided that the infants will receive the nirsevimab immunization
- Children have to be healthy according to the same health criteria applied in the well baby clinic when a child is immunized, e.g. also infants with small increases in body temperature or a cold are seen as children with normal health
- The parents/ legal representatives accept participation of their (unborn) child in the study according to the described procedures
- Presence of a signed informed consent (the parents/legal representatives have given written informed consent after receiving oral and written information)
- Nirsevimab group: Having received nirsevimab immunization before study entry
- Known or suspected serious underlying medical condition that can interfere with the results of the study. Such as, but not limited to, certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease, seizure disorder or cancer.
- Control group: Having received nirsevimab immunization
- Control group: Being hospitalized due to a confirmed RSV infection
- The biological mother received an RSV vaccination during pregnancy
- Nirsevimab group: Confirmed RSV infection before study entry
- Active or past immunosuppressive or immune modulating medication. However, for steroid treatment the exclusion criteria are: receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) steroid treatment; daily corticosteroids (locally, incl. inhaled steroids, are acceptable) within 2 weeks before study entry or repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) within 2 weeks before study entry. The use of hydrocortisone as a substitution therapy in case a subject does not produce sufficient amounts is allowed.
- Known or suspected immunological disorder
- Known or suspected bleeding disorder
- Premature infants born before 37 weeks gestational age
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.