Respiratory Syncytial Virus InfectionsPhase 3MELODYNCT03979313
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
A Phase 3 study testing MEDI8897 in people with Respiratory Syncytial Virus Infections, run by AstraZeneca at 198 sites in 31 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season. Read more about this study
- Who is it for?
- Ages 0 years to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- MEDI8897
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,012 participants
- Where
- 198 sitesin 31 countries
- Study dates
- 23 Jul 2019to 21 Mar 2023
- Phase
- Phase 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
- Infants who are entering their first RSV season at the time of screening
Who cannot join
- Meets national or other local criteria to receive commercial palivizumab
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination
Trial locations and contacts
198 sites in 31 countries.
198 sites in 31 countries
United States66 sites
Research Site
Anaheim, California, 92804
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80015
Research Site
Bardstown, Kentucky, 40004
Research Site
Baytown, Texas, 77521
Research Site
Birmingham, Alabama, 35205
Research Site
Boone, North Carolina, 28607
Research Site
Charlottesville, Virginia, 22902
Research Site
Chicago, Illinois, 60611
Research Site
Cincinnati, Ohio, 45229
Research Site
Cleveland, Ohio, 44109
Research Site
Cleveland, Ohio, 44121
Research Site
Colorado Springs, Colorado, 80922
Research Site
Columbia, Missouri, 65212
Research Site
Columbus, Ohio, 43205
Research Site
Dallas, Texas, 75251
Research Site
Dayton, Ohio, 45406
Research Site
Dayton, Ohio, 45414
Research Site
Downey, California, 90240
Research Site
Edinburg, Texas, 78539
Research Site
Erie, Pennsylvania, 16506
Research Site
Fayetteville, Arkansas, 72703
Research Site
Fort Defiance, Arizona, 86504
Research Site
Fort Gordon, Georgia, 30905
Research Site
Gainesville, Florida, 32653
Research Site
Gallup, New Mexico, 87301
Research Site
Hialeah, Florida, 33012
Research Site
Indianapolis, Indiana, 46202
Research Site
Jackson, Mississippi, 39216
Research Site
Kingsport, Tennessee, 37660
Research Site
Layton, Utah, 84041
Research Site
League City, Texas, 77573
Research Site
Lexington, Kentucky, 40517
Research Site
Lincoln, Nebraska, 68504
Research Site
Longview, Texas, 75605
Research Site
Marshfield, Wisconsin, 54449
Research Site
Memphis, Tennessee, 38103
Research Site
Miami, Florida, 33142
Research Site
Morgantown, West Virginia, 26506
Research Site
National City, California, 91950
Research Site
North Charleston, South Carolina, 29406
Research Site
Oak Lawn, Illinois, 60453
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Omaha, Nebraska, 68114
Research Site
Paramount, California, 90723
Research Site
Pearland, Texas, 77584
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Richmond, Virginia, 23219
Research Site
Roy, Utah, 84067
Research Site
Salt Lake City, Utah, 84107
Research Site
Salt Lake City, Utah, 84123
Research Site
San Antonio, Texas, 78240
Research Site
San Antonio, Texas, 78249
Research Site
Seattle, Washington, 98105
Research Site
Shiprock, New Mexico, 87420
Research Site
Shreveport, Louisiana, 71105
Research Site
Sioux Falls, South Dakota, 57105
Research Site
South Jordan, Utah, 84095
Research Site
St. George, Utah, 84790
Research Site
Syracuse, New York, 13210
Research Site
Tomball, Texas, 77375
Research Site
Tullahoma, Tennessee, 37388
Research Site
Warwick, Rhode Island, 02886
Research Site
Washington D.C., District of Columbia, 20016
Research Site
West Covina, California, 91790
Research Site
West Des Moines, Iowa, 50266
Spain16 sites
Research Site
Alicante, 03010
Research Site
Antequera, 29200
Research Site
Castellon, 12004
Research Site
Córdoba, 14004
Research Site
Granada, 18014
Research Site
Leganés, 28911
Research Site
Lleida, 25198
Research Site
Madrid, 28040
Research Site
Málaga, 29004
Research Site
Móstoles, 28938
Research Site
Pozuelo de Alarcón, 28223
Research Site
San Cristóbal de La Laguna, 38320
Research Site
Sant Cugat del Vallès, 08190
Research Site
Sant Joan d'Alacant, 03550
Research Site
Santiago de Compostela, 15706
Research Site
Valencia, 46017
South Africa10 sites
Research Site
Cape Town, 7505
Research Site
Cape Town, 7530
Research Site
Cape Town, 7800
Research Site
Durban, 4091
Research Site
Johannesburg, 2112
Research Site
Johannesburg, 2193
Research Site
Pretoria, 0087
Research Site
Pretoria, 0101
Research Site
Rondebosch, 7700
Research Site
Soweto, 2013
Finland9 sites
Research Site
Espoo, 02230
Research Site
Helsinki, 00100
Research Site
Jarvenpaa, 04400
Research Site
Kokkola, 67100
Research Site
Oulu, 90220
Research Site
Pori, 28100
Research Site
Seinäjoki, 60100
Research Site
Tampere, 33100
Research Site
Turku, 20520
Bulgaria8 sites
Research Site
Montana, 3400
Research Site
Pazardzhik, 4400
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4002
Research Site
Rousse, 7002
Research Site
Sofia, 1407
Research Site
Veliko Tarnovo, 5000
Japan8 sites
Research Site
Fukuyama-shi, 721-8511
Research Site
Kawasaki-shi, 210-0013
Research Site
Maebashi, 371-0811
Research Site
Okayama, 701-1192
Research Site
Osaka, 556-0005
Research Site
Sapporo, 062-0931
Research Site
Shizuoka, 420-0005
Research Site
Yokosuka-shi, 238-8558
France7 sites
Research Site
Amiens, 80054
Research Site
Bordeaux, 33000
Research Site
Brest, 29609
Research Site
Bron, 69677
Research Site
Caen, 14033
Research Site
Créteil, 94010
Research Site
Lille, 59020
Colombia6 sites
Research Site
Cali
Research Site
Chía, 250002
Research Site
Medellín, 50036
Research Site
Medellín, 500515
Research Site
Montería, 230002
Research Site
Soledad, 083001
Poland6 sites
Research Site
Krakow, 30-348
Research Site
Krakow, 30-363
Research Site
Łęczna, 21-010
Research Site
Torun, 87-100
Research Site
Wroclaw, 51-169
Research Site
Wroclaw, 53-149
Belgium5 sites
Research Site
Bruges, 8000
Research Site
Brussels, 1000
Research Site
Brussels, 1070
Research Site
Brussels, 1090
Research Site
Ghent, 9000
Estonia5 sites
Research Site
Paide, 72713
Research Site
Tallinn, 10117
Research Site
Tallinn, 10617
Research Site
Tallinn, 13419
Research Site
Tartu, 50406
Latvia5 sites
Research Site
Jēkabpils, LV-5201
Research Site
Riga, 1004
Research Site
Riga, LV1002
Research Site
Valmiera, 4200
Research Site
Valmiera, LV-4201
Ukraine5 sites
Research Site
Chernivtsі, 58001
Research Site
Dnipro, 49027
Research Site
Kyiv, 04050
Research Site
Sumy, 40022
Research Site
Vinnytsia, 21021
New Zealand4 sites
Research Site
Christchurch, 8011
Research Site
Grafton, 1023
Research Site
Papatoetoe, 2025
Research Site
Wellington, 6021
Panama4 sites
Research Site
Cuidad de Panama
Research Site
David
Research Site
La Chorrera
Research Site
Panama City
Russia4 sites
Research Site
Perm, 614066
Research Site
Saint Petersburg, 191025
Research Site
Saint Petersburg, 193312
Research Site
Saint Petersburg, 196084
Turkey (Türkiye)4 sites
Research Site
Adana, 01330
Research Site
Ankara, 06100
Research Site
Izmir, 35100
Research Site
Kocaeli, 41380
Canada3 sites
Research Site
Calgary, Alberta, T3B 6A8
Research Site
Pierrefonds, Quebec, H9H 4Y6
Research Site
Vancouver, British Columbia, V6H 3V4
Germany3 sites
Research Site
Frankenthal, 67227
Research Site
Leipzig, 04103
Research Site
Mannheim, 68161
Argentina2 sites
Research Site
San Miguel de Tucumán, 4000
Research Site
San Miguel de Tucumán, T4000NWB
United Kingdom2 sites
Research Site
Liverpool, L12 2AP
Research Site
London, SW17 0RE
About this study
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Read the detailed description
This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- MEDI8897, Placebo
- Keywords
- Respiratory Syncytial Virus, RSV, Late Preterm Infants, Healthy Infants, Lower Respiratory Tract 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
PlaceboDrug
Commercially available 0.9% (w/v) saline
| Study group | Role | What they receive |
|---|---|---|
| MEDI8897 | Experimental | Anti-RSV monoclonal antibody with an extended half-life Receives: Drug: MEDI8897 |
| Placebo | Placebo comparator | Commercially available 0.9% (w/v) saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Measured: Through 150 Days Post Dose
Secondary outcomes (3)
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Measured: Through 150 Days Post Dose
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Number of Subjects with at Least one Assessment
Measured: By visit until day 360 post dose
Anti-drug Antibody Results by Visit (As Treated Population)
Number of subjects with a positive result and a valid titer result at the specific visit
Measured: From baseline to 360 day post dose visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start23 Jul 2019
- Primary completion11 Mar 2021
- Study completion21 Mar 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 (9)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979313
- Sponsor's protocol ID
- D5290C00004
- Other IDs
- 2019-000114-11, 2019
- Acronym
- MELODY
- Status last verified
- Feb 2024
- First submitted
- 30 May 2019
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Bolanos R, Araos R, Gonzalez C, Sepulveda D, Falconi JF, Averin A, Atwood M, Quinn E, Law AW, Mendes D. Cost-effectiveness of strategies using preventive interventions to protect infants in Chile from respiratory syncytial virus. Expert Rev Vaccines. 2025 Dec;24(1):904-913. doi: 10.1080/14760584.2025.2562201. Epub 2025 Oct 2.
PubMed 40958705Arbetter D, Gopalakrishnan V, Aksyuk AA, Ahani B, Chang Y, Dagan R, Esser MT, Hammitt LL, Mankad VS, Saez-Llorens X, Shen D, Leach A, Kelly EJ, Villafana T, Wilkins D. Lower Respiratory Tract Infections Following Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab Immunization Versus Placebo: Analysis From a Phase 3 Randomized Clinical Trial (MELODY). Clin Infect Dis. 2025 Oct 6;81(3):634-644. doi: 10.1093/cid/ciae596.
PubMed 39656748Mankad 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 38921800Langer S, Holzapfel S, August L, Badura A, Wellmann S, Mack I. Parental knowledge and attitudes to infant immunization in the context of RSV: All about confidence? Vaccine. 2024 Oct 3;42(23):126050. doi: 10.1016/j.vaccine.2024.06.018. Epub 2024 Jun 19.
PubMed 38902186Dagan R, Hammitt LL, Seoane Nunez B, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Chang Y, Currie A, Grenham A, Shroff M, Takas T, Mankad VS, Leach A, Villafana T. Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season. J Pediatric Infect Dis Soc. 2024 Feb 26;13(2):144-147. doi: 10.1093/jpids/piad113.
PubMed 38219024Ahani B, Tuffy KM, Aksyuk AA, Wilkins D, Abram ME, Dagan R, Domachowske JB, Guest JD, Ji H, Kushnir A, Leach A, Madhi SA, Mankad VS, Simoes EAF, Sparklin B, Speer SD, Stanley AM, Tabor DE, Hamren UW, Kelly EJ, Villafana T. Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023 Jul 19;14(1):4347. doi: 10.1038/s41467-023-40057-8.
PubMed 37468530Muller WJ, Madhi SA, Seoane Nunez B, Baca Cots M, Bosheva M, Dagan R, Hammitt LL, Llapur CJ, Novoa JM, Saez Llorens X, Grenham A, Kelly EJ, Mankad VS, Shroff M, Takas T, Leach A, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants. N Engl J Med. 2023 Apr 20;388(16):1533-1534. doi: 10.1056/NEJMc2214773. Epub 2023 Apr 5. No abstract available.
PubMed 37018470Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
PubMed 35235726Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
PubMed 34774184
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
- ClinicalTrials.gov ID
- NCT03979313
- Acronym / sponsor ID
- MELODY / D5290C00004
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus, RSV, Late Preterm Infants, Healthy Infants, Lower Respiratory Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,012 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 28 Feb 2024
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 efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Detailed description
This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.
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 |
| Placebo | Placebo comparator | Drug: PlaceboCommercially available 0.9% (w/v) saline |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
- Infants who are entering their first RSV season at the time of screening
Key exclusion criteria (4 listed)
- Meets national or other local criteria to receive commercial palivizumab
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination
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 |
| PlaceboCommercially available 0.9% (w/v) saline | Drug | Placebo |
Primary outcome
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Time frame: Through 150 Days Post Dose
Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
3 secondary outcomes
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Time frame: Through 150 Days Post Dose
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Time frame: By visit until day 360 post dose
Anti-drug Antibody Results by Visit (As Treated Population)
Time frame: From baseline to 360 day post dose visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40958705Bolanos R, Araos R, Gonzalez C, Sepulveda D, Falconi JF, Averin A, Atwood M, Quinn E, Law AW, Mendes D. Cost-effectiveness of strategies using preventive interventions to protect infants in Chile from respiratory syncytial virus. Expert Rev Vaccines. 2025 Dec;24(1):904-913. doi: 10.1080/14760584.2025.2562201. Epub 2025 Oct 2.
- Derived from this study: PubMed 39656748Arbetter D, Gopalakrishnan V, Aksyuk AA, Ahani B, Chang Y, Dagan R, Esser MT, Hammitt LL, Mankad VS, Saez-Llorens X, Shen D, Leach A, Kelly EJ, Villafana T, Wilkins D. Lower Respiratory Tract Infections Following Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab Immunization Versus Placebo: Analysis From a Phase 3 Randomized Clinical Trial (MELODY). Clin Infect Dis. 2025 Oct 6;81(3):634-644. doi: 10.1093/cid/ciae596.
- 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 38902186Langer S, Holzapfel S, August L, Badura A, Wellmann S, Mack I. Parental knowledge and attitudes to infant immunization in the context of RSV: All about confidence? Vaccine. 2024 Oct 3;42(23):126050. doi: 10.1016/j.vaccine.2024.06.018. Epub 2024 Jun 19.
- Derived from this study: PubMed 38219024Dagan R, Hammitt LL, Seoane Nunez B, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Chang Y, Currie A, Grenham A, Shroff M, Takas T, Mankad VS, Leach A, Villafana T. Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season. J Pediatric Infect Dis Soc. 2024 Feb 26;13(2):144-147. doi: 10.1093/jpids/piad113.
- Derived from this study: PubMed 37468530Ahani B, Tuffy KM, Aksyuk AA, Wilkins D, Abram ME, Dagan R, Domachowske JB, Guest JD, Ji H, Kushnir A, Leach A, Madhi SA, Mankad VS, Simoes EAF, Sparklin B, Speer SD, Stanley AM, Tabor DE, Hamren UW, Kelly EJ, Villafana T. Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023 Jul 19;14(1):4347. doi: 10.1038/s41467-023-40057-8.
- Derived from this study: PubMed 37018470Muller WJ, Madhi SA, Seoane Nunez B, Baca Cots M, Bosheva M, Dagan R, Hammitt LL, Llapur CJ, Novoa JM, Saez Llorens X, Grenham A, Kelly EJ, Mankad VS, Shroff M, Takas T, Leach A, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants. N Engl J Med. 2023 Apr 20;388(16):1533-1534. doi: 10.1056/NEJMc2214773. Epub 2023 Apr 5. No abstract available.
- Derived from this study: PubMed 35235726Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
- Derived from this study: PubMed 34774184Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR synopsisLink 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.
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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.
198 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MEDI8897 in people with Respiratory Syncytial Virus Infections, run by AstraZeneca at 198 sites in 31 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 2 inclusion and 4 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 198 sites in United States, Spain, South Africa, Finland, Bulgaria and 26 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 28 Feb 2024). 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?
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) (time frame: Through 150 Days Post 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 NCT03979313, which also lists 9 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 28 Feb 2024.