Respiratory Syncytial Virus Infections
Conditions
Brief 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.
Interventions
DRUGNirsevimab
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.
Sponsors
AstraZeneca
IQVIA Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking is used. All involved know the identity of the intervention assignment.
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
No
Inclusion 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. 1. Immunodeficiency 2. Chronic Lung Disease 3. Congenital Heart Disease 4. Down syndrome 5. 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
Exclusion 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 (≥100.4°F \[≥38.0°C\], 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: 1. Known renal impairment 2. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511 | An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentrations of Nirsevimab | Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose | Serum samples were collected at specified timepoints to evaluate concentrations of nirsevimab at selected time points. |
| Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab | Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose | Blood samples were analyzed for the presence of ADAs for nirsevimab using an appropriately validated bioanalytical method. |
| Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels | Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose | Blood samples were collected for the determination anti-RSV nAb in serum using an appropriately validated bioanalytical method. |
Countries
Japan
Participant flow
Recruitment details
This Phase III, single-arm, open-label study was conducted at 9 investigational sites in Japan in infants (\< or equal to 12 months of age at enrolment) with congenital heart disease, chronic lung disease, immunocompromise, down syndrome, or born pre-term.
Pre-assignment details
The study had a screening visit (Day -30 to Day 1), study drug given in 2 doses (Day 1 and Day 150-180), and an end-of-study follow-up (360 days after the second or last dose). A total of 33 infants were enrolled. Final results are presented up to the last subject, last visit (LSLV) date of 24-Jul-2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous As-Treated Set 1 | 2.32 months STANDARD_DEVIATION 2.39 |
| Age, Continuous As-Treated Set 2 | 2.32 months STANDARD_DEVIATION 2.43 |
| Ethnicity (NIH/OMB) As-Treated Set 1 Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) As-Treated Set 1 Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) As-Treated Set 1 Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) As-Treated Set 2 Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) As-Treated Set 2 Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) As-Treated Set 2 Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized As-Treated Set 1 Asian | 33 Participants |
| Race/Ethnicity, Customized As-Treated Set 2 Asian | 32 Participants |
| Sex: Female, Male As-Treated Set 1 Female | 15 Participants |
| Sex: Female, Male As-Treated Set 1 Male | 18 Participants |
| Sex: Female, Male As-Treated Set 2 Female | 14 Participants |
| Sex: Female, Male As-Treated Set 2 Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 32 / 32 |
| serious Total, serious adverse events | 8 / 32 |
Outcome results
None listed