A study to investigate the safety, pharmacokinetics, occurrence of anti-drug antibody, and anti-RSV neutralizing antibody following 2 doses administration of nirsevimab (MEDI8897) in infants with certain health conditions or born pre-term in Japan

JRCT ID: jRCT2031230256

Registered date:26/07/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: RSV invection
• Date of first enrollment: 27/07/2023
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is <5 kg or 100 mg if body weight is >=5 kg. A 2nd fixed IM dose of 50 mg if body weight is <5 kg or 100 mg if body weight is >=5 kg will be administered 5 to 6 months following the 1st dose.

Outcome(s)

• Primary Outcome: Incidence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new-onset chronic diseases (NOCDs) through 360 days post 2nd dose

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 12month old
• Gender: Both

Include criteria

1.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
2.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.
(a)Immunodeficiency
(b)Chronic Lung Disease
(c)Congenital Heart Disease
(d)Down syndrome
(e)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
3.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.
4.The participant is available to complete the follow-up period for approximately 19 months, which will be approximately 1 year after receipt of 2nd dose of nirsevimab.

Exclude criteria

1.Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
2.A current, active RSV infection at the time of screening and investigational product administration
3.Any fever (>=100.4F [>=38.0C], regardless of route) or acute illness at the time of prior to investigational product administration
4.Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including:
(a)Known renal impairment
(b)Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
(c)Any seizure disorder or evolving or unstable neurological condition
5.Anticipated cardiac surgery within 5-6 months after enrollment
6.Prior history of a suspected or actual acute life-threatening event
7.Receipt or intended use of palivizumab in the current enrollment season
8.Any known allergy or history of allergic reaction to any component of nirsevimab
9.Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins
10.Concurrent enrollment in another interventional study, or prior receipt of any investigational agent
11.Anticipated survival of less than 1 year at the time of informed consent
12.Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results
13.Children of employees of the Sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Related Information

• Primary Sponsor: jRCT Inquiries IQVIA contact person