A Phase 3 interventional study of Motavizumab and Placebo in Healthy, sponsored by MedImmune LLC. Completed at 12 sites in United States. Open to participants aged 0 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by MedImmune LLC · Phase 3, Interventional, and Prevention
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season.
Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5 injections.
During their first RSV season, participants were evaluated monthly just prior to each injection of study drug for adverse events (AEs) (including medically attended otitis media), with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3, blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday.
MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive IM dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
Other: Placebo
Participants will receive IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
Biological: Motavizumab
Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
Also known as: MEDI-524
Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
Time frame: From study Day 0 through study Day 150
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. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. 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.
Time frame: From study Day 0 through study Day 150
Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI)
The RSV outpatient MA LRI was defined as an outpatient medically attended event designated as a lower respiratory illness with a positive RT-PCR RSV test. An 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 was determined by the principal investigator after review of the medical record and considering the presence of cough, retractions, rhonchi, wheezing, crackles, or rales, associated with symptoms (by history or clinical findings) of coryza, fever, or apnoea.
Time frame: From study Day 0 through study Day 150
Number of Participants With Medically Attended-Otitis Media (MA-OM) Events
Otitis media (OM) was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event.
Time frame: From study Day 0 through study Day 150
Number of Participants With Frequency of MA-OM Events
Otitis media was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute TM perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event. Number of participants with frequency of MA-OM events (either 0, 1, 2, 3, or greater than \[\>\] 3) are reported.
Time frame: From study Day 0 through study Day 150
Number of Participants With Medically Attended Wheezing Episodes
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion was that the wheezing does not represent a persistence of the previous episode. Number of participants with greater than or equal to (\>=) 1 MA wheezing events and \>= 3 MA wheezing events occurring from first through 3 years of age are reported.
Time frame: From first year through 3 years
Number of Participants With Serious Early Childhood Wheezing Episodes
Serious early childhood wheezing (SECW) was defined as: three or more medically attended wheezing events over a 12 month period occurring any time from the first through the third birthday, or a need for one or more courses of systemic steroids for a treatment of a medically attended wheezing event from the first through the third birthday, or a need for asthma-controller medication over a 12 month period for at least 3 consecutive months (\>= 90 days) or 5 cumulative months (\>= 150 days) any time from the first through the third birthday, or at least one inpatient wheezing event from the first through the third birthday.
Time frame: From first year through 3 years
Number of Participants With Frequency of Medically Attended Wheezing Events
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Number of participants with frequency of MA wheezing events (either 0, 1, 2, 3, 4, or greater than or equal to \[\>=\] 5) are reported.
Time frame: Study Day 0 through 3 years
Mean Trough Serum Concentrations of Motavizumab
The mean trough serum concentrations of motavizumab are reported.
Time frame: Day 0 (pre Dose 1) and Day 120 (Pre Dose 5)
Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose
The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported.
Time frame: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose
The number of participants with positive serum ADA to motavizumab after any dose are reported.
Time frame: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
The study was conducted from 15 Nov 2004 to 27 Dec 2010 in the United States of America.
| Milestone | Placebo | Motavizumab |
|---|---|---|
| Started | 710 | 1417 |
| Completed | 589 | 1192 |
| Not completed | 121 | 225 |
| Withdrew: Lost to follow-up | 10 | 22 |
| Withdrew: Withdrawal by subject | 106 | 195 |
| Withdrew: Death | 5 | 8 |
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
| Participants | Placebo | Motavizumab |
|---|---|---|
| Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | 80 | 21 |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. 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.
| Participants | Placebo | Motavizumab |
|---|---|---|
| TEAEs | 686 | 1361 |
| TESAEs | 148 | 212 |
The RSV outpatient MA LRI was defined as an outpatient medically attended event designated as a lower respiratory illness with a positive RT-PCR RSV test. An 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 was determined by the principal investigator after review of the medical record and considering the presence of cough, retractions, rhonchi, wheezing, crackles, or rales, associated with symptoms (by history or clinical findings) of coryza, fever, or apnoea.
| Participants | Placebo | Motavizumab |
|---|---|---|
| Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | 71 | 41 |
Otitis media (OM) was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event.
| Participants | Placebo | Motavizumab |
|---|---|---|
| Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | 275 | 532 |
Otitis media was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute TM perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event. Number of participants with frequency of MA-OM events (either 0, 1, 2, 3, or greater than \[\>\] 3) are reported.
| Participants | Placebo | Motavizumab |
|---|---|---|
| MA OM: 0 | 435 | 885 |
| MA OM: 1 | 190 | 372 |
| MA OM: 2 | 55 | 114 |
| MA OM: 3 | 26 | 32 |
| MA OM: >3 | 4 | 14 |
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion was that the wheezing does not represent a persistence of the previous episode. Number of participants with greater than or equal to (\>=) 1 MA wheezing events and \>= 3 MA wheezing events occurring from first through 3 years of age are reported.
| Participants | Placebo | Motavizumab |
|---|---|---|
| >= 1 MA wheezing events | 179 | 342 |
| >= 3 MA wheezing events | 16 | 35 |
Serious early childhood wheezing (SECW) was defined as: three or more medically attended wheezing events over a 12 month period occurring any time from the first through the third birthday, or a need for one or more courses of systemic steroids for a treatment of a medically attended wheezing event from the first through the third birthday, or a need for asthma-controller medication over a 12 month period for at least 3 consecutive months (\>= 90 days) or 5 cumulative months (\>= 150 days) any time from the first through the third birthday, or at least one inpatient wheezing event from the first through the third birthday.
| Participants | Placebo | Motavizumab |
|---|---|---|
| SECW | 90 | 190 |
| Three or more MA wheezing events over a 12 month period | 16 | 35 |
| Need of systemic steroids for a MA wheezing event | 66 | 144 |
| Asthma-controller medication for wheezing over a 12 month period | 2 | 11 |
| >= 1 hospitalization with MA wheezing | 47 | 91 |
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Number of participants with frequency of MA wheezing events (either 0, 1, 2, 3, 4, or greater than or equal to \[\>=\] 5) are reported.
| Participants | Placebo | Motavizumab |
|---|---|---|
| 0 events | 384 | 908 |
| 1 event | 182 | 288 |
| 2 events | 72 | 109 |
| 3 events | 34 | 44 |
| 4 events | 18 | 27 |
| >= 5 events | 20 | 41 |
The mean trough serum concentrations of motavizumab are reported.
| μg/mL | Motavizumab |
|---|---|
| Day 0 (Pre dose 1) | 0.003212 ± 0.07147 |
| Day 120 (pre dose 5) | 86.46 ± 31.77 |
The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported.
| Participants | Motavizumab |
|---|---|
| Day 0 (Pre Dose 1) | 0 |
| Day 120 (Pre Dose 5) | 3 |
The number of participants with positive serum ADA to motavizumab after any dose are reported.
| Participants | Motavizumab |
|---|---|
| Day 0 (Pre Dose 1) | 0 |
| Day 120 (Pre Dose 5) | 3 |
Collected over From study Day 0 through study Day 150. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PLACEBO | 5/708 (0.7%) | 148/708 (20.9%) | 682/708 (96.3%) |
| MOTAVIZUMAB | 8/1,414 (0.6%) | 212/1,414 (15%) | 1,345/1,414 (95.1%) |
| Event | PLACEBO | MOTAVIZUMAB |
|---|---|---|
| Respiratory syncytial virus bronchiolitisInfections and infestations | 38/708 | 16/1414 |
| BronchiolitisInfections and infestations | 35/708 | 29/1414 |
| PneumoniaInfections and infestations | 20/708 | 36/1414 |
| GastroenteritisInfections and infestations | 14/708 | 31/1414 |
| HyperbilirubinaemiaHepatobiliary disorders | 6/708 | 10/1414 |
| Pneumonia respiratory syncytial viralInfections and infestations | 6/708 | 1/1414 |
| Viral infectionInfections and infestations | 6/708 | 5/1414 |
| Fever neonatalGeneral disorders | 4/708 | 10/1414 |
| PyrexiaGeneral disorders | 3/708 | 8/1414 |
| Lower respiratory tract infectionInfections and infestations | 4/708 | 8/1414 |
| Event | PLACEBO | MOTAVIZUMAB |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 459/708 | 903/1414 |
| Otitis mediaInfections and infestations | 268/708 | 522/1414 |
| PyrexiaGeneral disorders | 160/708 | 307/1414 |
| Dermatitis diaperSkin and subcutaneous tissue disorders | 149/708 | 298/1414 |
| ConjunctivitisEye disorders | 136/708 | 271/1414 |
| GastroenteritisInfections and infestations | 113/708 | 196/1414 |
| DiarrhoeaGastrointestinal disorders | 106/708 | 196/1414 |
| Viral infectionInfections and infestations | 80/708 | 175/1414 |
| BronchiolitisInfections and infestations | 87/708 | 132/1414 |
| TeethingGastrointestinal disorders | 86/708 | 167/1414 |
The Intent to treat (ITT) population included all participants in the treatment group according to their randomized treatment group.
| Age, Continuous(Months) | Placebo | Motavizumab | Total |
|---|---|---|---|
| Mean | 2.13 ± 1.89 | 2.08 ± 1.92 | 2.10 ± 1.91 |
| Sex: Female, Male(Participants) | Placebo | Motavizumab | Total |
|---|---|---|---|
| Female | 343 | 710 | 1053 |
| Male | 367 | 707 | 1074 |
| Race/Ethnicity, Customized(Participants) | Placebo | Motavizumab | Total |
|---|---|---|---|
| Navajo | 576 | 1149 | 1725 |
| White Mountain Apache | 102 | 203 | 305 |
| San Carlos Apache | 15 | 28 | 43 |
| Zuni | 0 | 1 | 1 |
| Hopi | 8 | 19 | 27 |
| Other - Not specified | 9 | 17 | 26 |
Plan to share: 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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