Trial · NCT02878330
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
NCT02878330, Phase 2, Completed, MedImmune LLC; results first posted 2019-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. Trials, record NCT02878330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02878330
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
- NCT number
- NCT02878330
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,453 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- MEDI8897, Placebo
- First posted
- 2016-08-25
- Last updated
- 2019-10-14
- Results first posted
- 2019-10-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) | 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). |
| Secondary | Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) | From Day 1 through Day 151 | 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). |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Day 1 through Day 361 | 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. |
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs) | From Day 1 through Day 361 | 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. |
| Secondary | Serum Concentration of MEDI8897 | Days 91, 151, and 361 | |
| Secondary | Elimination Half-life (t1/2) of MEDI8897 | Day 91 through Day 361 | Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum. |
| Secondary | Number of Participants With Positive Anti-drug Antibodies to MEDI8897 | Days 91, 151, and 361 | The number of participants with positive serum antibodies to MEDI8897 are reported. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) | From Day 1 through Day 151 | The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) | From Day 1 through Day 151 | The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Day 1 through Day 361 | As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs) | From Day 1 through Day 361 | As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Concentration of MEDI8897 | Days 91, 151, and 361 | As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. | mcg/mL | MEAN |
| SECONDARY | Elimination Half-life (t1/2) of MEDI8897 | Day 91 through Day 361 | As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. Participants with sufficient additional pharmacokinetics (PK) samples from unscheduled visits were analysed for this outcome measure. | Days | MEAN |
| SECONDARY | Number of Participants With Positive Anti-drug Antibodies to MEDI8897 | Days 91, 151, and 361 | As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) | Placebo | 46 | Participants | ||
| Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) | MEDI8897 50 mg | 25 | Participants | ||
| Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) | Placebo | 20 | Participants | ||
| Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) | MEDI8897 50 mg | 8 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Placebo | TEAEs | 416 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | MEDI8897 50 mg | TEAEs | 834 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Placebo | TESAEs | 81 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | MEDI8897 50 mg | TESAEs | 108 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs) | Placebo | AESIs | 3 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs) | MEDI8897 50 mg | AESIs | 5 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 484 | |
| Overall Study | STARTED | MEDI8897 50 mg | 969 | |
| Overall Study | COMPLETED | Placebo | 455 | |
| Overall Study | COMPLETED | MEDI8897 50 mg | 913 | |
| Overall Study | NOT COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | MEDI8897 50 mg | 56 |
Source ClinicalTrials.gov
Adverse events262
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 17 | 479 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI8897 50 mg | 29 | 968 | 29 |
| other | Plagiocephaly | Congenital, familial and genetic disorders | Placebo | 3 | 479 | 3 |
| other | Plagiocephaly | Congenital, familial and genetic disorders | MEDI8897 50 mg | 15 | 968 | 15 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 10 | 479 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | MEDI8897 50 mg | 5 | 968 | 5 |
| other | Constipation | Gastrointestinal disorders | Placebo | 21 | 479 | 24 |
| other | Constipation | Gastrointestinal disorders | MEDI8897 50 mg | 34 | 968 | 36 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 49 | 479 | 55 |
| other | Diarrhoea | Gastrointestinal disorders | MEDI8897 50 mg | 98 | 968 | 113 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 3 | 479 |
| Total, all-cause mortality | MEDI8897 50 mg | 2 | 968 |
| Total, other adverse events | Placebo | 402 | 479 |
| Total, other adverse events | MEDI8897 50 mg | 804 | 968 |
| Total, serious adverse events | Placebo | 81 | 479 |
| Total, serious adverse events | MEDI8897 50 mg | 108 | 968 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MEDI8897 50 mg vs Placebo: Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) | Trial comparisons |
| MEDI8897 50 mg vs Placebo: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) | Trial comparisons |
| MEDI8897 50 mg vs Placebo: deaths from any cause | Trial comparisons |
| MEDI8897 50 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02878330
GET https://conductscience.org/api/trials/v1/NCT02878330/results?page=2