Participants Less Than 12 Months of Age With RSV IllnessPhase 2NCT00435227
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
A Phase 2 study testing Motavizumab in people with Participants Less Than 12 Months of Age With RSV Illness, run by MedImmune LLC at 31 sites in United States.
Trial summary
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Participants Less Than 12 Months of Age With RSV Illness
- What is being tested?
- Motavizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 31 sitesUnited States
- Study dates
- 20 Mar 2007to 31 May 2008
- 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 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previously healthy
- Age ≤12 months at the time of randomization
- Weight ≤10 kg at the time of randomization
- Gestational age ≥36 weeks
- RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
- Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate < 60 breaths/minute in children < 2 months and < 50 breaths/minute in children 2-12 months)
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- Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
- Randomization within 4 hours of being evaluated with a positive Binax® RSV test
- Written informed consent obtained from the participant's parent(s) or legal guardian
Who cannot join
- Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
- Prior medically diagnosed RSV infection
- Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- Requirement for supplemental oxygen (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
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- Mechanical ventilation at any time prior to the onset of the current RSV infection
- Congenital heart disease [children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
- Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
- Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
- Prior use of palivizumab (Synagis®) within the past 2 months
- Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Research Site
Atlanta, Georgia, 30342
Research Site
Augusta, Georgia, 30912
Research Site
Baltimore, Maryland
Research Site
Boston, Massachusetts, 02111
Research Site
Brooklyn, New York, 11203-2098
Research Site
Buffalo, New York, 14222-2099
West Virginia University Pediactric Center
Charleston, West Virginia, 25302
Research Site
Charleston, West Virginia, 72205
Research Site
Chicago, Illinois
Research Site
Dallas, Texas, 75230
Research Site
Dallas, Texas, 75390
Research Site
Detroit, Michigan, 48201
Research Site
Houston, Texas, 77030
Research Site
Huntington, West Virginia, 25701-3655
Research Site
Jonesboro, Arkansas, 72401
Research Site
Jonesboro, Arkansas
Research Site
Las Vegas, Nevada, 89107
Research Site
Little Rock, Arkansas, 72202
Research Site
Little Rock, Arkansas
Research Site
Miami, Florida
Research Site
Morgantown, West Virginia, 26506
Research Site
Nashville, Tennessee, 37232-2581
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Orange, California, 92868
Research Site
Paterson, New Jersey, 07503
Research Site
Richmond, Virginia, 23298
Research Site
San Diego, California, 92103
Research Site
Tampa, Florida, 33606
Research Site
The Bronx, New York
Research Site
Tucson, Arizona
Research Site
Youngstown, Ohio, 44051
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Single Intramuscular Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Outpatient Treatment of Children With RSV Illness
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.
Read the detailed description
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.
- Being tested
- Motavizumab, Placebo
- Keywords
- Respiratory Syncytial Viruses, RSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotavizumabBiological
Also called MEDI-524
A single IM dose of 30 mg/kg will be administered on Day 0 of the study.
PlaceboOther
A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Motavizumab | Experimental | Participants will receive a single IM dose of 30 mg/kg of motavizumab on Day 0 of the study. Receives: Biological: Motavizumab |
| Placebo | Placebo comparator | Participants will receive a single IM dose of placebo matched to motavizumab on Day 0 of the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Measured: Day 0
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Measured: Day 2
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Measured: Day 30
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Measured: Day 90
Secondary outcomes (18)
Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization
The percentage of participants who have progression of RSV illness that requires subsequent hospitalization is reported. RSV illness symptomps included fever, coryza, cough, and parental opinion of return to normal health and activity.
Measured: From Randomiation (Day 0) Up to Day 30
Respiratory Assessment Change Score (RACS) Derived From Baseline
The RACS assesses changes in wheezing and retractions as measured by the respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. Change in respiratory rate of less than or equal to (<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.
Measured: Baseline (Day 0); and Days 2, 7, and 30
Change From Baseline in Oxygen Saturation Level
Change from baseline in oxygen saturation level is reported.
Measured: Baseline (Day 0), Days 2, 7, and 30
Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
The RACS assesses changes in wheezing and retractions as measured by the RDAI score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of <= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration.
Measured: Baseline (Day 0) to Day 30
Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measured: Baseline (Day 0) to Day 30
Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measured: Baseline (Day 0) to Day 30
Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Measured: Baseline (Day 0) to Day 30
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported.
Measured: Baseline (Day 0) to Day 90
Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation Required
Measured: Baseline (Day 0) to Day 90
Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)
A LRI event is one that has a medical diagnosis of bronchiolitis or pneumonia. In the absence of such a medical diagnosis, the occurrence of LRI events will be determined by the principal investigator after review of the medical record and based on the presence of retractions or lower respiratory tract rhonchi, wheezing, crackles, or rales in children with a positive RSV test.
Measured: Baseline (Day 0) to Day 30
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Number of LRI infected participants who required hospitalization, ICU stay, supplemental oxygen, mechanical ventilation, and respiratory medications are reported.
Measured: Baseline (Day 0) to Day 30
RACS in Participants With LRI
The RACS assesses changes in wheezing and retractions as measured by RDAI score and changes in respiratory rate. A RDAI score is a measure of degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of <= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration. RACS in participants with LRI is reported.
Measured: From Baseline (Day 0) to Days 2, 7, and 30
Motavizumab Concentration in Upper Respiratory Tract
Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported.
Measured: Days 0 (pre-dose), 2, and 30
Serum Concentration of Motavizumab
Serum concentration of motavizumab is reported.
Measured: Days 2, 30, and 90
Numbers of Participants With Positive Anti-Motavizumab Antibodies
The number of participants with positive serum antibodies to motavizumab are reported.
Measured: Days 0 (pre-dose) and 90
Serum Cytokine Levels
Serum Cytokine Levels are reported.
Measured: Days 0 (pre-dose), 30, and 90
Nasal Wash Cytokine Levels
Nasal wash cytokine levels are reported.
Measured: Days 0 (pre-dose), 2, 30, and 90
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. A 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. The 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 the administration of study drug (Day 0) through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study start20 Mar 2007
- Primary completion31 May 2008
- Study completion31 May 2008
Why it stopped: The study was terminated early due to an inability to enroll the planned number of participants
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.
- Other trials for Participants Less Than 12 Months of Age With RSV IllnessStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Pamela Griffin, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435227
- Sponsor's protocol ID
- MI-CP146
- Status last verified
- Jul 2021
- First submitted
- 13 Feb 2007
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Single Intramuscular Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Outpatient Treatment of Children With RSV Illness
- ClinicalTrials.gov ID
- NCT00435227
- Acronym / sponsor ID
- MI-CP146
- Keywords
- Respiratory Syncytial Viruses, RSV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to an inability to enroll the planned number of participants
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2007 (actual)
- Primary completion
- 31 May 2008 (actual)
- Study completion
- 31 May 2008 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Posted 17 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.
Detailed description
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.
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 |
|---|---|---|
| Motavizumab | Experimental | Biological: MotavizumabParticipants will receive a single IM dose of 30 mg/kg of motavizumab on Day 0 of the study. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single IM dose of placebo matched to motavizumab on Day 0 of the study. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Previously healthy
- Age ≤12 months at the time of randomization
- Weight ≤10 kg at the time of randomization
- Gestational age ≥36 weeks
- RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
Key exclusion criteria (13 listed)
- Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
- Prior medically diagnosed RSV infection
- Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
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 |
|---|---|---|
| MotavizumabAlso: MEDI-524A single IM dose of 30 mg/kg will be administered on Day 0 of the study. | Biological | Motavizumab |
| PlaceboA single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study. | Other | Placebo |
Primary outcome
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0
Time frame: Day 0
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2
Time frame: Day 2
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30
Time frame: Day 30
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90
Time frame: Day 90
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
18 secondary outcomes
Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization
Time frame: From Randomiation (Day 0) Up to Day 30
Respiratory Assessment Change Score (RACS) Derived From Baseline
Time frame: Baseline (Day 0); and Days 2, 7, and 30
Change From Baseline in Oxygen Saturation Level
Time frame: Baseline (Day 0), Days 2, 7, and 30
Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Time frame: Baseline (Day 0) to Day 30
Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Time frame: Baseline (Day 0) to Day 30
Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Time frame: Baseline (Day 0) to Day 30
Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization
Time frame: Baseline (Day 0) to Day 30
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
Time frame: Baseline (Day 0) to Day 90
Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation Required
Time frame: Baseline (Day 0) to Day 90
Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)
Time frame: Baseline (Day 0) to Day 30
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Time frame: Baseline (Day 0) to Day 30
RACS in Participants With LRI
Time frame: From Baseline (Day 0) to Days 2, 7, and 30
Motavizumab Concentration in Upper Respiratory Tract
Time frame: Days 0 (pre-dose), 2, and 30
Serum Concentration of Motavizumab
Time frame: Days 2, 30, and 90
Numbers of Participants With Positive Anti-Motavizumab Antibodies
Time frame: Days 0 (pre-dose) and 90
Serum Cytokine Levels
Time frame: Days 0 (pre-dose), 30, and 90
Nasal Wash Cytokine Levels
Time frame: Days 0 (pre-dose), 2, 30, and 90
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From the administration of study drug (Day 0) through Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
M. Pamela Griffin, M.D. study director
MedImmune LLC
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motavizumab in people with Participants Less Than 12 Months of Age With RSV Illness, run by MedImmune LLC at 31 sites in United States.
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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 17 Aug 2021). 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?
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0 (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2021.