Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory Syncytial Virus Infections, Preterm Infants, Lower Respiratory Infection
Brief summary
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
Detailed description
This study is a pivotal Phase 2/3 randomized, double-blind, palivizumab-controlled study to evaluate the safety, pharmacokinetics (PK), anti-drug antibody (ADA) response, and descriptive efficacy for MEDI8897 in high-risk infants eligible to receive palivizumab when entering their first or second RSV season (Season 1 or Season 2, respectively). Approximately 900 palivizumab-eligible infants entering their first RSV season will be enrolled into one of 2 cohorts: (1) preterm cohort, including approximately 600 preterm infants (≤ 35 weeks gestational age \[GA\]) without CLD/CHD, or (2) CLD/CHD cohort, including approximately 300 infants with CLD of prematurity or hemodynamically significant CHD. A minimum of 100 infants with hemodynamically significant CHD will be enrolled. Within each cohort, randomization will be stratified by hemisphere (northern, southern) and subject age at the time of Season 1 randomization (≤ 3 months, \> 3 to ≤ 6 months, \> 6 months).
Interventions
DRUGPalivizumab
Approved anti-RSV monoclonal antibody
DRUGMEDI8897
Anti-RSV monoclonal antibody with an extended half-life
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
No
Inclusion criteria
1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with: 1. Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or 2. Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone 2. For the CLD/CHD cohort: 1. Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization 2. Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD 3. Infants who are entering their first RSV season at the time of screening 4. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations 5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator 6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
Exclusion criteria
1. Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to randomization 2. Any history of LRTI or active LRTI prior to, or at the time of, randomization 3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization 4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization 5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization 6. Anticipated cardiac surgery within 2 weeks after randomization 7. Anticipated survival of \< 6 months after randomization 8. Receipt of any investigational drug 9. Known renal impairment 10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 11. Clinically significant congenital anomaly of the respiratory tract 12. Chronic seizure, or evolving or unstable neurologic disorder 13. Prior history of a suspected or actual acute life-threatening event 14. Known immunodeficiency, including human immunodeficiency virus (HIV) 15. Mother with HIV infection (unless the child has been proven to be not infected) 16. Any known allergy, including to immunoglobulin products, or history of allergic reaction 17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination 18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study 19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results 20. Concurrent enrollment in another interventional study 21. 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 |
|---|---|---|
| Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | 360 days post first dose | Safety and tolerability of MEDI8897 will be assessed by the occurrence 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentrations of MEDI8897 and Palivizumab | Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2 | Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics. |
| Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum | 360 days post first dose | Incidence of ADA to MEDI8897 and palivizumab as assessed by the percentage of participants with any post-baseline ADA positive by treatment group. |
| Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | 150 days post first dose | Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2. Incidence of LRTI hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2. |
Countries
Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
In the overall population, 925 infants (615 in preterm cohort, 310 in CLD/CHD cohort) were enrolled from 25 countries and randomized (2:1) to MEDI8897 (n = 616) or palivizumab (n = 309). Of the 310 subjects in the Season 1 CLD/CHD cohort, 262 continued into the Season 2 phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| MEDI8897 Subjects who were randomized to MEDI8897 group in Season 1 | 616 |
| Palivizumab Subjects who were randomized to Palivizumab group in Season 1 | 309 |
| MEDI8897/MEDI8897 CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2. | 180 |
| Palivizumab/MEDI8897 CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2 | 40 |
| Palivizumab/Palivizumab CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2 | 42 |
| Total | 1,187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Season 1 | Death | 5 | 1 | 0 | 0 | 0 |
| Season 1 | Due to COVID-19 pandemic | 2 | 3 | 0 | 0 | 0 |
| Season 1 | Lost to Follow-up | 17 | 7 | 0 | 0 | 0 |
| Season 1 | Other | 6 | 7 | 0 | 0 | 0 |
| Season 1 | Withdrawal by parent/guardian | 43 | 28 | 0 | 0 | 0 |
| Season 2 | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 |
| Season 2 | Other | 0 | 0 | 2 | 0 | 0 |
| Season 2 | Withdrawal by parent/guardian | 0 | 0 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Palivizumab/Palivizumab | Palivizumab/MEDI8897 | MEDI8897/MEDI8897 | Total | MEDI8897 | Palivizumab |
|---|---|---|---|---|---|---|
| Age, Continuous Age at first dose of Season 2 (Months) | 16.132 Months STANDARD_DEVIATION 2.104 | 16.598 Months STANDARD_DEVIATION 2.4335 | 16.772 Months STANDARD_DEVIATION 2.7141 | 16.643 Months STANDARD_DEVIATION 2.5857 | — | — |
| Age, Continuous Age at randomization (months) | — | — | — | 3.911 Months STANDARD_DEVIATION 2.5206 | 3.947 Months STANDARD_DEVIATION 2.5513 | 3.840 Months STANDARD_DEVIATION 2.4608 |
| Chronic lung disease No | 0 Participants | 0 Participants | 0 Participants | 708 Participants | 0 Participants | 239 Participants |
| Chronic lung disease Yes | 0 Participants | 0 Participants | 132 Participants | 217 Participants | 0 Participants | 70 Participants |
| Congenital heart disease No | 0 Participants | 0 Participants | 0 Participants | 821 Participants | 0 Participants | 275 Participants |
| Congenital heart disease Yes | 11 Participants | 14 Participants | 0 Participants | 81 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 16 Participants | 11 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 15 Participants | 36 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 9 Participants | 12 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 732 Participants | 483 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 430 Participants | 297 Participants | 133 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 151 Participants | 319 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 614 | 1 / 304 | 0 / 180 | 0 / 40 | 0 / 42 |
| other Total, other adverse events | 435 / 614 | 211 / 304 | 129 / 180 | 31 / 40 | 29 / 42 |
| serious Total, serious adverse events | 80 / 614 | 38 / 304 | 23 / 180 | 4 / 40 | 2 / 42 |
Outcome results
Primary
Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
Safety and tolerability of MEDI8897 will be assessed by the occurrence 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)
Time frame: 360 days post first dose
Population: As-treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TEAE | 444 Participants |
| MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TESAE | 80 Participants |
| MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | AESI | 3 Participants |
| MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | NOCD | 3 Participants |
| Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TEAE | 215 Participants |
| Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | NOCD | 0 Participants |
| Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TESAE | 38 Participants |
| Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | AESI | 0 Participants |
| MEDI8897/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | NOCD | 1 Participants |
| MEDI8897/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TESAE | 23 Participants |
| MEDI8897/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | AESI | 1 Participants |
| MEDI8897/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TEAE | 130 Participants |
| Palivizumab/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TEAE | 31 Participants |
| Palivizumab/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TESAE | 4 Participants |
| Palivizumab/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | NOCD | 0 Participants |
| Palivizumab/MEDI8897 | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | AESI | 0 Participants |
| Palivizumab/Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | NOCD | 0 Participants |
| Palivizumab/Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | AESI | 0 Participants |
| Palivizumab/Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TESAE | 2 Participants |
| Palivizumab/Palivizumab | Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) | TEAE | 29 Participants |
Secondary
Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
Incidence of ADA to MEDI8897 and palivizumab as assessed by the percentage of participants with any post-baseline ADA positive by treatment group.
Time frame: 360 days post first dose
Population: Participants in as-treated population and with at least 1 post-baseline ADA sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI8897 | Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum | 5.8 Percentage of participants |
| Palivizumab | Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum | 6.9 Percentage of participants |
| MEDI8897/MEDI8897 | Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum | 11.7 Percentage of participants |
| Palivizumab/MEDI8897 | Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum | 2.5 Percentage of participants |
| Palivizumab/Palivizumab | Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum | 14.3 Percentage of participants |
Secondary
Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose
Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2. Incidence of LRTI hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2.
Time frame: 150 days post first dose
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MEDI8897 | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI through 150 days post first dose, % | 0.6 Percentage of participants |
| MEDI8897 | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, % | 0.3 Percentage of participants |
| Palivizumab | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI through 150 days post first dose, % | 1.0 Percentage of participants |
| Palivizumab | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, % | 0.6 Percentage of participants |
| MEDI8897/MEDI8897 | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI through 150 days post first dose, % | 0 Percentage of participants |
| MEDI8897/MEDI8897 | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, % | 0 Percentage of participants |
| Palivizumab/MEDI8897 | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, % | 0 Percentage of participants |
| Palivizumab/MEDI8897 | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI through 150 days post first dose, % | 0 Percentage of participants |
| Palivizumab/Palivizumab | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI through 150 days post first dose, % | 0 Percentage of participants |
| Palivizumab/Palivizumab | Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose | Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, % | 0 Percentage of participants |
Secondary
Serum Concentrations of MEDI8897 and Palivizumab
Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics.
Time frame: Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Population: As-treated population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 15 | 104.75 ug/mL | Geometric Coefficient of Variation 61.8 |
| MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 151 | 25.38 ug/mL | Geometric Coefficient of Variation 58.8 |
| MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 31 | 85.35 ug/mL | Geometric Coefficient of Variation 74.2 |
| Palivizumab | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 31 | 48.10 ug/mL | Geometric Coefficient of Variation 50 |
| Palivizumab | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 15 | 66.43 ug/mL | Geometric Coefficient of Variation 55.7 |
| Palivizumab | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 151 | 101.56 ug/mL | Geometric Coefficient of Variation 65.6 |
| MEDI8897/MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 31 | 89.71 ug/mL | Geometric Coefficient of Variation 369.5 |
| MEDI8897/MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 15 | 149.38 ug/mL | Geometric Coefficient of Variation 169.2 |
| MEDI8897/MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 151 | 39.86 ug/mL | Geometric Coefficient of Variation 145.9 |
| Palivizumab/MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 15 | 97.70 ug/mL | Geometric Coefficient of Variation 302 |
| Palivizumab/MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 151 | 37.95 ug/mL | Geometric Coefficient of Variation 118.6 |
| Palivizumab/MEDI8897 | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 31 | 124.89 ug/mL | Geometric Coefficient of Variation 256.1 |
| Palivizumab/Palivizumab | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 31 | 57.77 ug/mL | Geometric Coefficient of Variation 56.3 |
| Palivizumab/Palivizumab | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 15 | 59.62 ug/mL | Geometric Coefficient of Variation 102.4 |
| Palivizumab/Palivizumab | Serum Concentrations of MEDI8897 and Palivizumab | Serum concentrations of MEDI8897 and Palivizumab at Day 151 | 67.66 ug/mL | Geometric Coefficient of Variation 111.4 |