Respiratory Syncytial Virus InfectionsPhase 2MEDI8897 Ph2bNCT02878330
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
A Phase 2 study testing MEDI8897 in people with Respiratory Syncytial Virus Infections, run by MedImmune LLC at 161 sites in 23 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 preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season. Read more about this study
- Who is it for?
- Ages Up to 365 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- MEDI8897
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,453 participants
- Where
- 161 sitesin 23 countries
- Study dates
- 3 Nov 2016to 6 Dec 2018
- Phase
- Phase 2
- 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 Up to 365 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
- Infants who are entering their first full RSV season at the time of screening.
Who cannot join
- Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
- Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization.
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of 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
161 sites in 23 countries.
161 sites in 23 countries
United States60 sites
Research Site
Anaheim, California, 92804
Research Site
Anaheim, California, 92805
Research Site
Atlanta, Georgia, 30322
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Augusta, Georgia, 30912
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Aurora, Colorado, 80045
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Birmingham, Alabama, 35205
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Boone, North Carolina, 28607
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Charleston, South Carolina, 29425
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Chicago, Illinois, 60611
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Cincinnati, Ohio, 45229
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Cleveland, Ohio, 44109
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Colorado Springs, Colorado, 80922
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Columbia, Missouri, 65212
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Columbus, Ohio, 43205
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Columbus, Ohio, 43231
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Dayton, Ohio, 45414
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Detroit, Michigan, 48201
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Downey, California, 90241
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Edinburg, Texas, 78539
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Erie, Pennsylvania, 16506
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Fort Worth, Texas, 76107
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Gainesville, Florida, 32607
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Galveston, Texas, 77555
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Gresham, Oregon, 97030
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Hartford, Connecticut, 06106
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Huntington, West Virginia, 25701
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Jackson, Mississippi, 39216
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Layton, Utah, 84041
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Lincoln, Nebraska, 68504
Research Site
Long Beach, California, 90806
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Longview, Texas, 75605
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Los Angeles, California, 90027
Research Site
Madison, Wisconsin, 53792
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Memphis, Tennessee, 38103
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Mineola, New York, 11501
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Morgantown, West Virginia, 26506
Research Site
New Hyde Park, New York, 11040
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North Charleston, South Carolina, 29406
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Oak Lawn, Illinois, 60068
Research Site
Oklahoma City, Oklahoma, 73104
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Omaha, Nebraska, 68124
Research Site
Omaha, Nebraska, 68134
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Omaha, Nebraska, 68198
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Orem, Utah, 84057
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Orlando, Florida, 32806
Research Site
Paramount, California, 90723
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Park Ridge, Illinois, 60068
Research Site
Pittsburgh, Pennsylvania, 15224
Research Site
Raleigh, North Carolina, 27609
Research Site
San Antonio, Texas, 78249
Research Site
San Diego, California, 92123
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Seattle, Washington, 98105
Research Site
Sioux Falls, South Dakota, 57104
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South Bend, Indiana, 46601
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South Miami, Florida, 33143
Research Site
Stony Brook, New York, 11794
Research Site
Syracuse, New York, 13210-2306
Research Site
Syracuse, Utah, 84075
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West Covina, California, 91790
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Woburn, Massachusetts, 01801
Hungary13 sites
Research Site
Budapest, 1062
Research Site
Budapest, 1094
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Budapest, 1131
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Budapest, 1204
Research Site
Gyula, 5700
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3526
Research Site
Nagykanizsa, 8800
Research Site
Nyireyghaza, 4400
Research Site
Sopron, 9400
Research Site
Szeged, 6720
Research Site
Szekszárd, 7100
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Veszprém, 8200
Spain12 sites
Research Site
Alicante, 03010
Research Site
Boadilla del Monte, 28660
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Córdoba, 14004
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Granada, 18014
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Lleida, 25198
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Madrid, 28040
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Madrid, 28046
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Málaga, 29011
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Sant Cugat del Vallès, 8190
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Sant Joan d'Alacant, 03550
Research Site
Santiago de Compostela, 15706
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Valencia, 46017
South Africa8 sites
Research Site
Cape Town, 7500
Research Site
Cape Town, 7700
Research Site
Claremont, 7708
Research Site
Durban, 4091
Research Site
Johannesburg, 2013
Research Site
Johannesburg, 2193
Research Site
Pietermaritzburg, 3201
Research Site
Pretoria, 0087
Chile7 sites
Research Site
Maipú, 9250000
Research Site
Santiago, 8053095
Research Site
Santiago, 8380453
Research Site
Santiago, 8420383
Research Site
Santiago, 8880465
Research Site
Valdivia, 5090000
Research Site
Viña del Mar, 2520594
Brazil6 sites
Research Site
Botucatu, 18618-970
Research Site
Campinas, 13084-791
Research Site
Canoas, 92425-900
Research Site
Curitiba, 80250-060
Research Site
Juiz de Fora, 36025-330
Research Site
Passo Fundo, 99010-080
France6 sites
Research Site
Bordeaux, 33000
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Brest, 29609
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Bron, 69677
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Caen, 14033
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Dijon, 21079
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Tours, 37044
Turkey (Türkiye)6 sites
Research Site
Adana, 1260
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Ankara, 06100
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Antalya, 07070
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Izmir, 35100
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Izmir, 35210
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Kocaeli, 41380
Bulgaria5 sites
Research Site
Pleven, 5800
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Plovdiv, 4002
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Rousse, 7002
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Sofia, 1407
Research Site
Sofia, 1431
Poland5 sites
Research Site
Bydgoszcz, 85168
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Gdansk, 80402
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Krakow, 30-349
Research Site
Krakow, 30-663
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Łęczna, 21-010
United Kingdom5 sites
Research Site
Brighton, BN2 5BE
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Bristol, BS2 8BJ
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London, SW17 0RE
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Oxford, OX3 7EJ
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Southampton, SO16 6YD
Italy4 sites
Research Site
Genova, 16100
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Padova, 35128
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Torino, 10126
Research Site
Verona, 37126
Czechia3 sites
Research Site
Havlíčkův Brod, 580 22
Research Site
Prague, 14059
Research Site
Prague, 14710
Latvia3 sites
Research Site
Jēkabpils, LV-5201
Research Site
Riga, LV1002
Research Site
Valmiera, 4200
New Zealand3 sites
Research Site
Christchurch, 8011
Research Site
Otahuhu, 2025
Research Site
Wellington, 6021
Argentina2 sites
Research Site
Bahía Blanca, B8001HXM
Research Site
Guaymallen Mendoza, 5519
About this study
Official title: A Phase 2b 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 Preterm Infants
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.
Read the detailed description
This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- MEDI8897, Placebo
- Keywords
- Respiratory Syncytial Virus, RSV, Preterm 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
A single IM dose of 50 mg on Day 1 of the study.
PlaceboDrug
A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study. Receives: Drug: Placebo |
| MEDI8897 50 mg | Experimental | Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study. Receives: Drug: MEDI8897 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
Measured: From Day 1 through Day 151
Secondary outcomes (6)
Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).
Measured: From Day 1 through Day 151
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: From Day 1 through Day 361
Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.
Measured: From Day 1 through Day 361
Serum Concentration of MEDI8897
Measured: Days 91, 151, and 361
Elimination Half-life (t1/2) of MEDI8897
Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.
Measured: Day 91 through Day 361
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
The number of participants with positive serum antibodies to MEDI8897 are reported.
Measured: Days 91, 151, and 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start3 Nov 2016
- Primary completion17 Jul 2018
- Study completion6 Dec 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878330
- Sponsor's protocol ID
- D5290C00003
- Acronym
- MEDI8897 Ph2b
- Status last verified
- Sep 2019
- First submitted
- 22 Aug 2016
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 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 38902186Ahani 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 37468530Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
PubMed 32726528
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b 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 Preterm Infants
- ClinicalTrials.gov ID
- NCT02878330
- Acronym / sponsor ID
- MEDI8897 Ph2b / D5290C00003
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus, RSV, Preterm Infants, Lower Respiratory Tract Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,453 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Posted 14 Oct 2019
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 preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.
Detailed description
This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the 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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study. |
| MEDI8897 50 mg | Experimental | Drug: MEDI8897Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study. |
Who may qualify
- Ages
- Up to 365 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
- Infants who are entering their first full RSV season at the time of screening.
Key exclusion criteria (5 listed)
- Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
- Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization.
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of 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 |
|---|---|---|
| MEDI8897A single IM dose of 50 mg on Day 1 of the study. | Drug | MEDI8897 50 mg |
| PlaceboA single IM dose of placebo matched to MEDI8897 on Day 1 of the study. | Drug | Placebo |
Primary outcome
Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
Time frame: From Day 1 through Day 151
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
6 secondary outcomes
Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
Time frame: From Day 1 through Day 151
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Day 1 through Day 361
Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
Time frame: From Day 1 through Day 361
Serum Concentration of MEDI8897
Time frame: Days 91, 151, and 361
Elimination Half-life (t1/2) of MEDI8897
Time frame: Day 91 through Day 361
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Time frame: Days 91, 151, and 361
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- 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 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 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 32726528Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
- D5290C00003\_Redacted\_protocol-amendment-1\_Red16JLU19Link provided by the sponsor.
- D5290C00003\_MEDI8897-Combined SAP\_PDFAv1.0Link provided by the sponsor.
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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.
161 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI8897 in people with Respiratory Syncytial Virus Infections, run by MedImmune LLC at 161 sites in 23 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 5 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 161 sites in United States, Hungary, Spain, South Africa, Chile and 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Oct 2019). 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 Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) (time frame: From Day 1 through Day 151). 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 NCT02878330, which also lists 4 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 14 Oct 2019.