Respiratory Syncytial Virus (RSV)
Conditions
Keywords
Bronchopulmonary dysplasia (BPD), RSV hospitalization, Palivizumab, Immunoprophylaxis, Chronic lung disease (CLD) of prematurity
Brief summary
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease \[CLD\] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease \[CHD\]).
Detailed description
Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.
Interventions
DRUGPalivizumab
Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: * Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment * Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment * Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery \[ultrasound acceptable\]) or the need for daily medication to manage hemodynamically significant CHD
Exclusion criteria
(main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With RSV Hospitalization | Approximately 6 months | An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received Supplemental Oxygen While Hospitalized | Approximately 6 months | Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms. |
| Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement | Approximately 6 months | Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms. |
| Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization | Approximately 6 months | — |
| Total Number of RSV-Hospitalization Days | Approximately 6 months | — |
| Percentage of Participants Who Received Mechanical Ventilation | Approximately 6 months | — |
| Total Days of Mechanical Ventilation During RSV-hospitalization | Approximately 6 months | — |
| Total Days of RSV-ICU Stay | Approximately 6 months | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children at High Risk of Severe RSV Infection A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Children at High Risk of Severe RSV Infection |
|---|---|
| Age, Continuous | 6.22 months STANDARD_DEVIATION 4.428 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 6 / 50 | 6 / 50 |
Outcome results
Primary
Percentage of Participants With RSV Hospitalization
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
Time frame: Approximately 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children at High Risk of Severe RSV Infection | Percentage of Participants With RSV Hospitalization | 0.0 percentage of participants |
Secondary
Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
Secondary
Percentage of Participants Who Received Mechanical Ventilation
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
Secondary
Percentage of Participants Who Received Supplemental Oxygen While Hospitalized
Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
Secondary
Total Days of Mechanical Ventilation During RSV-hospitalization
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
Secondary
Total Days of RSV-ICU Stay
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
Secondary
Total Number of RSV-Hospitalization Days
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
Secondary
Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement
Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
Time frame: Approximately 6 months
Population: All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.