A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses… (NCT06042049) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
Japan33 participantsStarted 2023-07-27
Plain-language summary
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
Study details include
* The study duration is approximately 21 months with a 2-month enrollment period.
* Study intervention is 2 doses administered 5- 6 months apart.
* The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.
Who can participate
Age range
0 Years – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent and any locally required authorization obtained from the participant's parent(s)/legally authorized representative(s) before performing any protocol-related procedures, including screening evaluations
. Japanese infants of ≤12 months of age eligible to receive palivizumab in accordance with national or local guidelines and those who must meet at least one of the following conditions at the time of informed consent.
. Immunodeficiency
. Chronic Lung Disease
. Congenital Heart Disease
. Down syndrome
. Born pre-term ≤28 wks Gestation age and aged ≤12 months, or born pre-term \>28 wks and ≤35 wks Gestation age and aged ≤6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
Timeframe: From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511
. The participant's parent(s)/legally authorized representative(s) can understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.
Exclusion criteria
. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
. A current, active RSV infection at the time of screening and investigational product administration
. Any fever (≥100.4°F \[≥38.0°C\], regardless of route) or acute illness at the time of prior to investigational product administration
. Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including:
. Known renal impairment
. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
. Any seizure disorder or evolving or unstable neurological condition
. Anticipated cardiac surgery within 5-6 months after enrollment