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 range0 Years – 1 Year
SexALL
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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
✓. 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
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