Respiratory Syncytial Virus InfectionsPhase 2/3NCT03959488
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
A Phase 2/3 study testing MEDI8897 and Palivizumab in people with Respiratory Syncytial Virus Infections, run by AstraZeneca at 128 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 1 year
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- MEDI8897 and Palivizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 925 participants
- Where
- 128 sitesin 26 countries
- Study dates
- 30 Jul 2019to 20 Jan 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
- Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
- For the CLD/CHD cohort:
- 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
- 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
Show all 10Show fewer
- Infants who are entering their first RSV season at the time of screening
- 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
- 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
- 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
Who cannot join
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- Any history of LRTI or active LRTI prior to, or at the time of, randomization
- Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
- Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
- Anticipated cardiac surgery within 2 weeks after randomization
Show all 21Show fewer
- Anticipated survival of < 6 months after randomization
- Receipt of any investigational drug
- Known renal impairment
- Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- Clinically significant congenital anomaly of the respiratory tract
- Chronic seizure, or evolving or unstable neurologic disorder
- Prior history of a suspected or actual acute life-threatening event
- Known immunodeficiency, including human immunodeficiency virus (HIV)
- Mother with HIV infection (unless the child has been proven to be not infected)
- Any known allergy, including to immunoglobulin products, or history of allergic reaction
- Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
- Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
- 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
- Concurrent enrollment in another interventional study
- 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
Trial locations and contacts
128 sites in 26 countries.
128 sites in 26 countries
United States30 sites
Research Site
Anaheim, California, 92804
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80045
Research Site
Charlottesville, Virginia, 22902
Research Site
Chicago, Illinois, 60611
Research Site
Cincinnati, Ohio, 45229
Research Site
Colorado Springs, Colorado, 80922
Research Site
Columbia, Missouri, 65201
Research Site
Columbus, Ohio, 43205
Research Site
Corpus Christi, Texas, 78411
Research Site
Durham, North Carolina, 27710
Research Site
Greenville, North Carolina, 27834
Research Site
Greenville, South Carolina, 29607
Research Site
Indianapolis, Indiana, 46202
Research Site
Jackson, Mississippi, 39216
Research Site
Layton, Utah, 84041
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90027
Research Site
Louisville, Kentucky, 40202
Research Site
Mineola, New York, 11501
Research Site
Morgantown, West Virginia, 26506
Research Site
National City, California, 91950
Research Site
Paramount, California, 90723
Research Site
Seattle, Washington, 98105
Research Site
South Bend, Indiana, 46617
Research Site
St. George, Utah, 84790
Research Site
Syracuse, New York, 13210
Research Site
Washington D.C., District of Columbia, 20016
Research Site
West Covina, California, 91790
Research Site
West Des Moines, Iowa, 50266
Bulgaria10 sites
Research Site
Montana, 3400
Research Site
Pazardzhik, 4400
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4003
Research Site
Rousse, 7002
Research Site
Sliven, 8800
Research Site
Sofia, 1309
Research Site
Sofia, 1407
Research Site
Veliko Tarnovo, 5000
Spain10 sites
Research Site
Alicante, 03010
Research Site
Boadilla del Monte, 28660
Research Site
Elche, 03203
Research Site
Leganés, 28911
Research Site
Lleida, 25198
Research Site
Madrid, 28046
Research Site
Málaga, 29004
Research Site
Pozuelo de Alarcón, 28223
Research Site
Sant Cugat del Vallès, 08190
Research Site
Tarragona, 43007
France9 sites
Research Site
Amiens, 80054
Research Site
Bordeaux, 33000
Research Site
Brest, 29609
Research Site
Bron, 69677
Research Site
Caen, 1403
Research Site
Créteil, 94010
Research Site
Grenoble, 38043
Research Site
Marseille, 13015
Research Site
Pau, 64046
Russia7 sites
Research Site
Kazan', 420012
Research Site
Novosibirsk, 630089
Research Site
Perm, 614066
Research Site
Saint Petersburg, 191025
Research Site
Saint Petersburg, 193312
Research Site
Saint Petersburg, 197341
Research Site
Yaroslavl, 150003
South Africa7 sites
Research Site
Cape Town, 7505
Research Site
Cape Town, 7800
Research Site
Johannesburg, 2112
Research Site
Johannesburg, 2193
Research Site
Pretoria, 0087
Research Site
Pretoria, 0101
Research Site
Soweto, 2013
Ukraine7 sites
Research Site
Chernivtsі, 58001
Research Site
Dnipro, 49006
Research Site
Ivano-Frankivsk, 76014
Research Site
Kharkiv Region, 61093
Research Site
Odesa, 65031
Research Site
Sumy, 40022
Research Site
Vinnytsia, 21000
Japan6 sites
Research Site
Fukui-shi, 918-8503
Research Site
Fukuoka, 813-0017
Research Site
Kitakyusyu-shi, 806-8501
Research Site
Maebashi, 371-0811
Research Site
Saitama Shi, 336 8522
Research Site
Setagaya-ku, 157-8535
Hungary5 sites
Research Site
Baja, 6500
Research Site
Budapest, 1096
Research Site
Debrecen, 4032
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3526
Poland5 sites
Research Site
Bydgoszcz, 85 168
Research Site
Gdansk, 80-214
Research Site
Krakow, 30-348
Research Site
Krakow, 31-624
Research Site
Wroclaw, 51-169
Germany3 sites
Research Site
Frankenthal, 67227
Research Site
Leipzig, 04103
Research Site
Mannheim, 68161
Latvia3 sites
Research Site
Jēkabpils, LV-5201
Research Site
Riga, 1004
Research Site
Riga, LV1002
South Korea3 sites
Research Site
Ansan-si, 15355
Research Site
Seoul, 06351
Research Site
Suwon, 16499
Turkey (Türkiye)3 sites
Research Site
Adana, 01330
Research Site
Izmir, 35100
Research Site
Kocaeli, 41380
United Kingdom3 sites
Research Site
Leicester, LE3 9QP
Research Site
London, W2 1NY
Research Site
Nottingham, NG7 2UH
Canada2 sites
Research Site
Edmonton, Alberta, T6G 1C9
Research Site
Vancouver, British Columbia, V6H 3V4
About this study
Official title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
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.
Read the 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).
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- MEDI8897, Palivizumab
- Keywords
- Respiratory Syncytial Virus Infections, Preterm Infants, Lower Respiratory Infection
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI8897Drug
Anti-RSV monoclonal antibody with an extended half-life
PalivizumabDrug
Approved anti-RSV monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| MEDI8897 | Experimental | anti-RSV monoclonal antibody with an extended half-life Receives: Drug: MEDI8897 |
| Palivizumab | Active comparator | anti-RSV monoclonal antibody Receives: Drug: Palivizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 360 days post first dose
Secondary outcomes (3)
Serum Concentrations of MEDI8897 and Palivizumab
Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics.
Measured: Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
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.
Measured: 360 days post first dose
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.
Measured: 150 days post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start30 Jul 2019
- Primary completion3 May 2021
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 925 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959488
- Sponsor's protocol ID
- D5290C00005
- Other IDs
- 2019-000201-69, 2019
- Status last verified
- Sep 2023
- First submitted
- 21 May 2019
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Publications
Mankad VS, Leach A, Chang Y, Wahlby Hamren U, Kiazand A, Kubiak RJ, Takas T, Villafana T, Shroff M. Comprehensive Summary of Safety Data on Nirsevimab in Infants and Children from All Pivotal Randomized Clinical Trials. Pathogens. 2024 Jun 13;13(6):503. doi: 10.3390/pathogens13060503.
PubMed 38921800Domachowske J, Madhi SA, Simoes EAF, Atanasova V, Cabanas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186. No abstract available.
PubMed 35235733
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
- ClinicalTrials.gov ID
- NCT03959488
- Acronym / sponsor ID
- D5290C00005
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus Infections, Preterm Infants, Lower Respiratory Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 925 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI8897 | Experimental | Drug: MEDI8897anti-RSV monoclonal antibody with an extended half-life |
| Palivizumab | Active comparator | Drug: Palivizumabanti-RSV monoclonal antibody |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- For the CLD/CHD cohort:
- Infants who are entering their first RSV season at the time of screening
- 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
- 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
Key exclusion criteria (21 listed)
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- Any history of LRTI or active LRTI prior to, or at the time of, randomization
- Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
- Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI8897Anti-RSV monoclonal antibody with an extended half-life | Drug | MEDI8897 |
| PalivizumabApproved anti-RSV monoclonal antibody | Drug | Palivizumab |
Primary outcome
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)
Time frame: 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)
3 secondary outcomes
Serum Concentrations of MEDI8897 and Palivizumab
Time frame: Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
Time frame: 360 days post first dose
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
Time frame: 150 days post first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38921800Mankad VS, Leach A, Chang Y, Wahlby Hamren U, Kiazand A, Kubiak RJ, Takas T, Villafana T, Shroff M. Comprehensive Summary of Safety Data on Nirsevimab in Infants and Children from All Pivotal Randomized Clinical Trials. Pathogens. 2024 Jun 13;13(6):503. doi: 10.3390/pathogens13060503.
- Derived from this study: PubMed 35235733Domachowske J, Madhi SA, Simoes EAF, Atanasova V, Cabanas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186. No abstract available.
- CSR SynopsisLink provided by the sponsor.
- MEDLEY ProtocolLink provided by the sponsor.
- Statistical Analysis Plan (SAP)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
128 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MEDI8897 and Palivizumab in people with Respiratory Syncytial Virus Infections, run by AstraZeneca at 128 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 sites in United States, Bulgaria, Spain, France, Russia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 360 days post first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959488, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.