HealthyPhase 1/2MEDI-559NCT00767416
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
A Phase 1/2 study testing MEDI-559 in people with Healthy, run by MedImmune LLC at 76 sites in 2 countries.
Trial summary
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 1 to <24 months of age. Read more about this study
- Who is it for?
- Ages 1 month to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MEDI-559
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 76 sitesin 2 countries
- Study dates
- Oct 2008to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 1 month to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female whose age on the day of randomization falls within one of the two age cohorts: Cohort 1: 5 to <24 months (reached their 5th month birthday but not yet reached their 2nd year birthday); Cohort 2: 1 to < 3 months (>28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Subject is seronegative to RSV at screening
- Subject was the product of normal full term pregnancy (defined as 36-42 weeks gestation)
- Subject is in general good health
- Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
- Subject's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
Who cannot join
- Any fever (≥ 100.4°F [≥ 38.0°C]), regardless of route within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
- Cohort 1 only: weight ≤ 5th percentile for age on the day of randomization
- Cohort 2 only: history of low birth weight (ie, <2500 grams at birth) or weight ≤ 5th percentile for age on the day of randomization
- Living in the same home or enrolled in the same classroom at day care with infants <6 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
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- Contact with pregnant caregiver within 28 days after each dose
- Living in a household with someone who is immunocompromised within 28 days after each dose; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after each study vaccine dosing
- Living in a household with someone who works in the healthcare field and who has direct patient care responsibilities within 28 days after each dose
- Living in a household with someone who is a day care provider or preschool teacher for children <6 months of age within 28 days after each dose
Trial locations and contacts
76 sites in 2 countries.
76 sites in 2 countries
United States75 sites
Research Site
Ames, Iowa, 50010
Research Site
Anaheim, California, 92804
Research Site
Bardstown, Kentucky, 40004
Research Site
Boston, Massachusetts, 02111
Research Site
Bridgeton, Missouri, 63044
Research Site
Brooklyn, New York, 11219
Research Site
Charlottesville, Virginia, 22902
Research Site
Chicago, Illinois, 60614
Research Site
Cleveland, Ohio, 44109
Research Site
Cleveland, Ohio, 44121
Research Site
Colonial Heights, Virginia, 23834
Research Site
Conway, Arkansas, 72034
Research Site
Corpus Christi, Texas, 78414
Research Site
Cypress, California, 90630
Research Site
Dalton, Georgia, 30721
Research Site
Downey, California, 90241
Research Site
Endwell, New York, 13760
Research Site
Fall River, Massachusetts, 02724
Research Site
Fishers, Indiana, 46037
Research Site
Franklin, Tennessee, 37067
Research Site
Fredrick, Maryland, 21215
Research Site
Greenville, Alabama, 36037
Research Site
Hartford, Connecticut, 06106
Research Site
Houston, Texas, 77036
Research Site
Houston, Texas, 77055
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Huber Heights, Ohio, 45424
Research Site
Huntington Beach, California, 92647
Research Site
Huntsville, Alabama, 35802
Research Site
Jackson, Tennessee, 38305
Research Site
Johnson City, Tennessee, 37604
Research Site
Kansas City, Missouri, 64132
Research Site
Kingsport, Tennessee, 37660
Research Site
Lakewood, California, 90712
Research Site
Layton, Utah, 84041
Research Site
Lexington, Kentucky, 40503
Research Site
Lexington, Kentucky, 40509
Research Site
Little Rock, Arkansas, 72202
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90015
Research Site
Los Angeles, California, 90024
Research Site
Louisville, Kentucky, 40202
Research Site
Louisville, Kentucky, 40207
Research Site
Metarie, Louisiana, 70006
Research Site
Miami, Florida, 33142
Research Site
Miami, Florida, 33155
Research Site
Midlothian, Virginia, 23113
Research Site
Mobile, Alabama, 36608
Research Site
New Albany, Indiana, 47150
Research Site
Norman, Oklahoma, 73071
Research Site
Omaha, Nebraska, 68131
Research Site
Omaha, Nebraska, 68134
Research Site
Orange City, Florida, 32763
Research Site
Paducah, Kentucky, 42003
Research Site
Paramount, California, 90723
Research Site
Richmond, Virginia, 23219
Research Site
San Angelo, Texas, 76904
Research Site
San Antonio, Texas, 78205
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78258
Research Site
San Diego, California, 92103
Research Site
Santa Ana, California, 92705
Research Site
South Bend, Indiana, 46601
Research Site
Spartanburg, South Carolina, 29303
Research Site
St. George, Utah, 84790
Research Site
Stony Brook, New York, 11794
Research Site
Syracuse, New York, 13210
Research Site
Syracuse, Utah, 84075
Research Site
Tampa, Florida, 33606
Research Site
Thornton, Colorado, 80223
Research Site
Tomball, Texas, 77375
Research Site
Tulsa, Oklahoma, 74127
Research Site
Walla Walla, Washington, 99362
Research Site
Warwick, Rhode Island, 02886
Research Site
Washington D.C., District of Columbia, 20058
About this study
Official title: A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <24 Month-Old Children
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 1 to <24 months of age.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multi-dose, Phase 1/2a multi-center trial to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-559 in RSV seronegative infants 5 to <24 months of age and in infants 1 to <3 months of age regardless of baseline serostatus. The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 5 to <24 months of age and to healthy infants 1 to <3 months of age regardless of baseline serostatus.
MEDI-559 will be administered at a dose of 10^5 fluorescent focus units (FFU) on a 0, 2, and 4 month schedule to two cohorts of subjects in a step-wise fashion. The target sample size for this study is 320 subjects, with 160 subjects 5 to <24 months of age enrolled into Cohort 1 and 160 subjects 1 to <3 months of age enrolled into Cohort 2. Each cohort will be randomized 1:1 (MEDI-559 to placebo) and stratified by site. Cohort 1 will initiate dosing at 10^5 FFU MEDI-559. Blinded safety data from the first 40 subjects enrolled in Cohort 1 for the 28 days following administration of the first dose of vaccine will be reviewed. If no safety concerns are noted, Cohort 2 will initiate dosing at 10^5 FFU. Enrollment into Cohort 2 will be halted after approximately 40 subjects have been randomized, and blinded safety data will be reviewed through 28 days post Dose 1. If no safety concerns are noted, the remainder of Cohort 2 will be enrolled. All subjects will be followed through 365 days after randomization to ensure that each subject has been followed through an RSV season.
- Conditions
- Healthy
- Being tested
- MEDI-559, Placebo
- Keywords
- MEDI-559, Respiratory Syncytial Virus, RSV, Pediatric, Vaccine, respiratory syncytial virus, RSV, pediatric, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-559Biological
Cohort 1 (5 to <24 months): N=80 MEDI-559 at 10^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.
PlaceboOther
Cohort 1 (5 to < 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 MEDI-559 | Experimental | MEDI-559 Receives: Biological: MEDI-559 |
| Cohort 1 Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited symptoms after Dose 1
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever >100.4°F (>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Measured: Through Day 28 after each dose
Incidence of solicited symptoms after Dose 2
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever >100.4°F (>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Measured: Through Day 28 after each dose
Incidence of solicited symptoms after Dose 3
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever >100.4°F (>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Measured: Through Day 28 after each dose
Incidence of adverse events (AEs) after Dose 1
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Through Day 28 after each dose
Incidence of AEs after Dose 2
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Through Day 28 after each dose
Incidence of AEs after Dose 3
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Through Day 28 after each dose
Incidence of medically-attended lower respiratory illnesses (MA-LRIs) after Dose 1
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Measured: Through Day 28 after each dose
Incidence of MA-LRIs after Dose 2
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Measured: Through Day 28 after each dose
Incidence of MA-LRIs after Dose 3
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Measured: Through Day 28 after each dose
Incidence of SAEs
An SAE is any adverse event that results in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly/birth defect (in the offspring of a subject); an important medical event that may not result in death, threaten life or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, it may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Administration of Dose 1 (Day 0) through Day 28 post final dose
Secondary outcomes (13)
Incidence of MEDI-559 shedding
Number (%) of subjects who shed vaccine-type virus
Measured: Day 7-10 after Dose 1, 2, and 3
Incidence of MEDI-559 shedding
Number (%) of subjects who shed vaccine-type virus
Measured: Day 12-18 after Dose 1, 2, and 3
Incidence of MEDI-559 shedding
Number (%) of subjects who shed vaccine-type virus
Measured: Day 28-34 post Dose 1, 2, and 3
Post-vaccination seroresponse against RSV
Seroresponse is defined as a ≥ 4-fold rise from baseline as measured by microneutralization assay
Measured: Day 28 post final dose
Phenotypic stability of recovered vaccine-type virus
Number (%) of nasal wash samples containing vaccine-type virus that is found to be phenotypically stable
Measured: Day 7-10 post any dose
Phenotypic stability of recovered vaccine-type virus
Number (%) of nasal wash samples containing vaccine-type virus that is found to be phenotypically stable
Measured: Day 12-18 post any dose
Phenotypic stability of recovered vaccine-type virus
Number (%) of nasal wash samples containing vaccine-type virus that is found to be phenotypically stable
Measured: Day 28-34 post any dose
Genotypic stability of recovered vaccine-type virus
Number (%) of nasal wash samples containing vaccine-type virus that is found to be genotypically stable
Measured: Day 7-10 post any dose
Genotypic stability of recovered vaccine-type virus
Number (%) of nasal wash samples containing vaccine-type virus that is found to be genotypically stable
Measured: Day 12-18 post any dose
Genotypic stability of recovered vaccine-type virus
Number (%) of nasal wash samples containing vaccine-type virus that is found to be genotypically stable
Measured: Day 28-34 post any dose
Incidence of MA-LRIs
Number (%) of subjects with MA-LRIs occurring from Study Day 0 through the end of study
Measured: Study Day 0 through 365 days post randomization
Incidence of SAEs
Number (%) of subjects with SAEs occurring from Study Day 0 through 365 days post randomization
Measured: Study Day 0 post Dose 1 through 365 days post randomization
Incidence of significant new medical conditions (SNMCs)
Number (%) of subjects with SNMCs from administration of Dose 1 through 365 days post randomization
Measured: Study Day 0 post Dose 1 through 365 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Sliman, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767416
- Sponsor's protocol ID
- MI-CP147
- Acronym
- MEDI-559
- Status last verified
- Jul 2016
- First submitted
- 3 Oct 2008
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malkin E, Yogev R, Abughali N, Sliman J, Wang CK, Zuo F, Yang CF, Eickhoff M, Esser MT, Tang RS, Dubovsky F. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104. eCollection 2013.
PubMed 24204744
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <24 Month-Old Children
- ClinicalTrials.gov ID
- NCT00767416
- Acronym / sponsor ID
- MEDI-559 / MI-CP147
- Conditions
- Healthy
- Keywords
- MEDI-559, Respiratory Syncytial Virus, RSV, Pediatric, Vaccine, respiratory syncytial virus, RSV, pediatric, vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 1 to <24 months of age.
Detailed description
This is a randomized, double-blind, placebo-controlled, multi-dose, Phase 1/2a multi-center trial to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-559 in RSV seronegative infants 5 to <24 months of age and in infants 1 to <3 months of age regardless of baseline serostatus. The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 5 to <24 months of age and to healthy infants 1 to <3 months of age regardless of baseline serostatus.
MEDI-559 will be administered at a dose of 10^5 fluorescent focus units (FFU) on a 0, 2, and 4 month schedule to two cohorts of subjects in a step-wise fashion. The target sample size for this study is 320 subjects, with 160 subjects 5 to <24 months of age enrolled into Cohort 1 and 160 subjects 1 to <3 months of age enrolled into Cohort 2. Each cohort will be randomized 1:1 (MEDI-559 to placebo) and stratified by site. Cohort 1 will initiate dosing at 10^5 FFU MEDI-559. Blinded safety data from the first 40 subjects enrolled in Cohort 1 for the 28 days following administration of the first dose of vaccine will be reviewed. If no safety concerns are noted, Cohort 2 will initiate dosing at 10^5 FFU. Enrollment into Cohort 2 will be halted after approximately 40 subjects have been randomized, and blinded safety data will be reviewed through 28 days post Dose 1. If no safety concerns are noted, the remainder of Cohort 2 will be enrolled. All subjects will be followed through 365 days after randomization to ensure that each subject has been followed through an RSV season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 MEDI-559 | Experimental | Biological: MEDI-559MEDI-559 |
| Cohort 1 Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 1 month to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female whose age on the day of randomization falls within one of the two age cohorts: Cohort 1: 5 to <24 months (reached their 5th month birthday but not yet reached their 2nd year birthday); Cohort 2: 1 to < 3 months (>28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Subject is seronegative to RSV at screening
- Subject was the product of normal full term pregnancy (defined as 36-42 weeks gestation)
- Subject is in general good health
- Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
Key exclusion criteria (10 listed)
- Any fever (≥ 100.4°F [≥ 38.0°C]), regardless of route within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
- Cohort 1 only: weight ≤ 5th percentile for age on the day of randomization
- Cohort 2 only: history of low birth weight (ie, <2500 grams at birth) or weight ≤ 5th percentile for age on the day of randomization
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 |
|---|---|---|
| MEDI-559Cohort 1 (5 to <24 months): N=80 MEDI-559 at 10^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer. | Biological | Cohort 1 MEDI-559 |
| PlaceboCohort 1 (5 to < 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer. | Other | Cohort 1 Placebo |
Primary outcome
Incidence of solicited symptoms after Dose 1
Time frame: Through Day 28 after each dose
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever >100.4°F (>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Incidence of solicited symptoms after Dose 2
Time frame: Through Day 28 after each dose
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever >100.4°F (>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Incidence of solicited symptoms after Dose 3
Time frame: Through Day 28 after each dose
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever >100.4°F (>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Incidence of adverse events (AEs) after Dose 1
Time frame: Through Day 28 after each dose
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Incidence of AEs after Dose 2
Time frame: Through Day 28 after each dose
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Incidence of AEs after Dose 3
Time frame: Through Day 28 after each dose
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Incidence of medically-attended lower respiratory illnesses (MA-LRIs) after Dose 1
Time frame: Through Day 28 after each dose
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Incidence of MA-LRIs after Dose 2
Time frame: Through Day 28 after each dose
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Incidence of MA-LRIs after Dose 3
Time frame: Through Day 28 after each dose
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Incidence of SAEs
Time frame: Administration of Dose 1 (Day 0) through Day 28 post final dose
An SAE is any adverse event that results in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly/birth defect (in the offspring of a subject); an important medical event that may not result in death, threaten life or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, it may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
13 secondary outcomes
Incidence of MEDI-559 shedding
Time frame: Day 7-10 after Dose 1, 2, and 3
Incidence of MEDI-559 shedding
Time frame: Day 12-18 after Dose 1, 2, and 3
Incidence of MEDI-559 shedding
Time frame: Day 28-34 post Dose 1, 2, and 3
Post-vaccination seroresponse against RSV
Time frame: Day 28 post final dose
Phenotypic stability of recovered vaccine-type virus
Time frame: Day 7-10 post any dose
Phenotypic stability of recovered vaccine-type virus
Time frame: Day 12-18 post any dose
Phenotypic stability of recovered vaccine-type virus
Time frame: Day 28-34 post any dose
Genotypic stability of recovered vaccine-type virus
Time frame: Day 7-10 post any dose
Genotypic stability of recovered vaccine-type virus
Time frame: Day 12-18 post any dose
Genotypic stability of recovered vaccine-type virus
Time frame: Day 28-34 post any dose
Incidence of MA-LRIs
Time frame: Study Day 0 through 365 days post randomization
Incidence of SAEs
Time frame: Study Day 0 post Dose 1 through 365 days post randomization
Incidence of significant new medical conditions (SNMCs)
Time frame: Study Day 0 post Dose 1 through 365 days post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 24204744Malkin E, Yogev R, Abughali N, Sliman J, Wang CK, Zuo F, Yang CF, Eickhoff M, Esser MT, Tang RS, Dubovsky F. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104. eCollection 2013.
- MEDI-559\_CP-147\_Protocol\_Redacted\_13Nov13Link 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.
Joseph Sliman, M.D. study director
MedImmune LLC
76 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEDI-559 in people with Healthy, run by MedImmune LLC at 76 sites in 2 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 6 inclusion and 10 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Puerto Rico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of solicited symptoms after Dose 1 (time frame: Through Day 28 after each dose). The study lists 10 primary outcomes in all. 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 NCT00767416, which also lists 1 linked publication.
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 20 Jul 2016.