A Study to Evaluate the Safety, Tolerability, Immunogenic... | NCT00686075 | Trialant
NCT00686075
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Sep 26, 2014Estimated
Enrollment
1,338Actual
Phase
Phase 1Phase 2
Conditions
Healthy
Interventions
MEDI-534, Cohort 1
Placebo, Cohort 1
MEDI-534, Cohort 2
Placebo, Cohort 2
MEDI-534, Cohort 3
Placebo, Cohort 3
MEDI-534, Cohort 4
Placebo, Cohort 4
MEDI-534, Cohort 5
Placebo, Cohort 5
Countries
United States
Australia
Brazil
Canada
Finland
Germany
Israel
South Africa
Spain
Protocol Section
Identification Module
NCT ID
NCT00686075
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MI-CP178
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants
Official Title
A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-old Children and in 2 Month-old Infants
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Sep 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2008
Primary Completion Date
Aug 2012Actual
Completion Date
Aug 2012Actual
First Submitted Date
May 23, 2008
First Submission Date that Met QC Criteria
May 28, 2008
First Posted Date
May 29, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 22, 2014
Results First Submitted that Met QC Criteria
Sep 22, 2014
Results First Posted Date
Sep 26, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 22, 2014
Last Update Posted Date
Sep 26, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.
Detailed Description
This is a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety and tolerability of multiple doses of MEDI-534 at 10^5 or 10^6 median tissue culture infectious dose (TCID50) in RSV and PIV3 seronegative children 6 to <24 months of age and at dosages of 10^4, 10^5 or 10^6 TCID50 in unscreened infants 2 months of age.
Conditions Module
Conditions
Healthy
Keywords
Respiratory Syncytial Virus (RSV)
Parainfluenza Virus Type 3 (PIV3)
MEDI-534
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,338Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI-534, Cohort 1
Experimental
Participants aged 6 to less than (<) 24 months will receive MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
Biological: MEDI-534, Cohort 1
Placebo, Cohort 1
Placebo Comparator
Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Other: Placebo, Cohort 1
MEDI-534, Cohort 2
Experimental
Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Biological: MEDI-534, Cohort 2
Placebo, Cohort 2
Placebo Comparator
Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Other: Placebo, Cohort 2
MEDI-534, Cohort 3
Experimental
Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI-534, Cohort 1
Biological
Participants aged 6 to less than (<) 24 months will receive MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Symptoms After Dose 1
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Within 28 days after Dose 1
Number of Participants With Solicited Symptoms After Dose 2
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Within 28 days after Dose 2
Number of Participants With Solicited Symptoms After Dose 3
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Within 28 days after Dose 3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Shed Vaccine-Type Virus
Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.
7, 12 and 28 days after Dose 1, 2 and 3
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female whose age on the day of randomization falls within one of the two age groups:
6 to less than (<) 24 months (more than [>] 6 months of age and not yet reached their 2nd year birthday), Cohorts 1 and 2 2 months (+/- 4 weeks), Cohorts 3, 4, and 5
Cohorts 1 and 2 only: Subject is seronegative to both Respiratory Syncytial Virus (RSV) and human Parainfluenza Virus Type 3 (hPIV3) at Screening
Subject whose gestational age was greater than or equal to (>=) 36 weeks
Subject is in general good health with normal growth (that is, body weight greater than (>) third percentile per world health organization [WHO] simplified weight-per-age field tables
Subject's legal representative is available by telephone
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's legal representative
Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
Subject is available to complete the follow-up period 1-year after receipt of the first dose of study vaccine
Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol.
Exclusion Criteria:
Any fever (>=100.4 degrees Fahrenheit [>=38.0 degrees Celsius], regardless of route) or lower respiratory illness within 7 days prior to randomization
Moderate or severe nasal congestion that in the investigator's opinion could interfere with intranasal delivery of study vaccine
Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications for the systemic treatment of common childhood symptoms (that is, pain relievers, decongestants or cough suppressants) are permitted according to the judgment of the investigator
Any current or expected receipt of immunosuppressive agents including steroids (>=2 milligram per kilogram [mg/kg] per day of prednisone or its equivalent, or >=20 milligram per day [mg/day] if the subject weighs >10 kilogram [kg], given daily or on alternate days for >=14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for >=30 days; the use of topical steroids is permitted according to the judgment of the investigator
History of receipt of blood transfusion or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing
Receipt of any live virus vaccine (excluding oral polio vaccine and rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
Receipt of any inactivated (that is, non-live) vaccine or oral polio vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
Known or suspected immunodeficiency, including human immunodeficiency virus (HIV) infection
Expected to be living in the same home or enrolled in the same classroom at day care with infants <6 months within 28 days after each dose
Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study)
Expected contact with a pregnant caregiver within 28 days after each dose
A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after any study vaccine dose
Expected household contact within 28 days after each dose with a health care provider for immunocompromised subjects or who is a day care provider for infants under the age of 6 months
History of allergic reaction to any component of the study vaccine
Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
Known or suspected active or chronic hepatitis infection
History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation for respiratory illness (excludes elective mechanical ventilation during surgery for subjects in Cohorts 1 and 2)
Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation.
Yang CF, Wang CK, Malkin E, Schickli JH, Shambaugh C, Zuo F, Galinski MS, Dubovsky F; Study Group; Tang RS. Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine. Vaccine. 2013 Jun 10;31(26):2822-7. doi: 10.1016/j.vaccine.2013.04.006. Epub 2013 Apr 16.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
A total of 720 participants were randomized in the study. An additional 618 participants were screened but not randomized in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
FG001
Placebo, Cohort 1
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Belgium
Chile
France
Italy
New Zealand
Puerto Rico
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: MEDI-534, Cohort 3
Placebo, Cohort 3
Placebo Comparator
Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
Other: Placebo, Cohort 3
MEDI-534, Cohort 4
Experimental
Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Biological: MEDI-534, Cohort 4
Placebo, Cohort 4
Placebo Comparator
Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Other: Placebo, Cohort 4
MEDI-534, Cohort 5
Experimental
Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Biological: MEDI-534, Cohort 5
Placebo, Cohort 5
Placebo Comparator
Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Other: Placebo, Cohort 5
MEDI-534, Cohort 1
Placebo, Cohort 1
Other
Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 1
MEDI-534, Cohort 2
Biological
Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
MEDI-534, Cohort 2
Placebo, Cohort 2
Other
Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 2
MEDI-534, Cohort 3
Biological
Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
MEDI-534, Cohort 3
Placebo, Cohort 3
Other
Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 3
MEDI-534, Cohort 4
Biological
Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
MEDI-534, Cohort 4
Placebo, Cohort 4
Other
Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 4
MEDI-534, Cohort 5
Biological
Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
MEDI-534, Cohort 5
Placebo, Cohort 5
Other
Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 5
Within 28 days after Dose 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.
Within 28 days after Dose 2
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
Within 28 days after Dose 3
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
Within 28 days after Dose 1
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
Within 28 days after Dose 2
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
Within 28 days after Dose 3
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea.
Within 28 days after Dose 1
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea.
Within 28 days after Dose 2
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea.
Within 28 days after Dose 3
Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
Day 28 after Dose 3
Genotypic Stability of Recovered Vaccine-Type Virus
Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
Within 28 days after any dose
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
Day 0 to Day 365
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
Day 0 to Day 365
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.
Day 0 to Day 365
Bentonville
Arkansas
72712
United States
Research Site
Little Rock
Arkansas
72202
United States
Research Site
Anaheim
California
92801
United States
Research Site
Anaheim
California
United States
Research Site
Bell Gardens
California
90201
United States
Research Site
Downey
California
90241
United States
Research Site
Lakewood
California
90712
United States
Research Site
Long Beach
California
United States
Research Site
Paramount
California
90723
United States
Research Site
San Diego
California
92103
United States
Research Site
West Covina
California
91790
United States
Research Site
Thornton
Colorado
United States
Research Site
Gainesville
Florida
32607
United States
Research Site
Tampa
Florida
33606
United States
Research Site
Dalton
Georgia
30721
United States
Research Site
Chicago
Illinois
60614
United States
Research Site
Kansas City
Kansas
United States
Research Site
Topeka
Kansas
66604
United States
Research Site
Lexington
Kentucky
40503
United States
Research Site
Paducah
Kentucky
42003
United States
Research Site
Shreveport
Louisiana
United States
Research Site
Saint Paul
Minnesota
55108
United States
Research Site
Bridgeton
Missouri
63044
United States
Research Site
Omaha
Nebraska
68131
United States
Research Site
Omaha
Nebraska
68134
United States
Research Site
Las Vegas
Nevada
United States
Research Site
Brooklyn
New York
United States
Research Site
Johnson City
New York
United States
Research Site
Lake Success
New York
11042
United States
Research Site
Stony Brook
New York
11794-8111
United States
Research Site
Syracuse
New York
13210
United States
Research Site
New Bern
North Carolina
28562
United States
Research Site
Cincinnati
Ohio
45229
United States
Research Site
Gresham
Oregon
97030
United States
Research Site
Pittsburgh
Pennsylvania
United States
Research Site
Sellersville
Pennsylvania
18960
United States
Research Site
Jackson
Tennessee
38305
United States
Research Site
Amarillo
Texas
United States
Research Site
Dallas
Texas
United States
Research Site
Houston
Texas
77030
United States
Research Site
Poteet
Texas
United States
Research Site
San Antonio
Texas
78229
United States
Research Site
San Antonio
Texas
78258
United States
Research Site
San Antonio
Texas
United States
Research Site
Tomball
Texas
77070
United States
Research Site
Layton
Utah
84041
United States
Research Site
Orem
Utah
84058
United States
Research Site
St. George
Utah
84790
United States
Research Site
Midlothian
Virginia
23113
United States
Research Site
Huntington
West Virginia
25701
United States
Research Site
Garran
Australian Capital Territory
2605
Australia
Research Site
Herston
Queensland
4006
Australia
Research Site
North Adelaide
South Australia
5006
Australia
Research Site
Subiaco
Western Australia
6008
Australia
Research Site
Passo Fundo-RS
Rio Grande do Sul
99010
Brazil
Research Site
São Paulo
São Paulo
05437-010
Brazil
Research Site
Porto Alegre - RS
Brazil
Research Site
Porto Alegre/RS
90035-903
Brazil
Research Site
Ribeirao Preto - SP
14048-990
Brazil
Research Site
Sao Paulo - SP
Brazil
Research Site
São Paulo
01221-020
Brazil
Research Site
Brampton
Ontario
L6W3E1
Canada
Research Site
Saskatoon
Saskatchewan
S7N 0W8
Canada
Research Site
Helsinki
FI-00930
Finland
Research Site
Jarvenpaa
04400
Finland
Research Site
Kokkola
FI-67100
Finland
Research Site
Kuopio
FI-70211
Finland
Research Site
Lahti
FI-15140
Finland
Research Site
Oulu
FI-90220
Finland
Research Site
Pori
FI-28100
Finland
Research Site
Tampere
33100
Finland
Research Site
Turku
FI-20520
Finland
Research Site
Berlin
10365
Germany
Research Site
Freiburg im Breisgau
79106
Germany
Research Site
Mainz
Germany
Research Site
Netanya
Israel
Research Site
Johannesburg
Gauteng
2013
South Africa
Research Site
Pretoria
Gauteng
0001
South Africa
Research Site
Belle Ville Cape Town
Western Cape
7530
South Africa
Research Site
Cape Town
Western Cape
7824
South Africa
Research Site
AlmerÃa
Andalusia
04007
Spain
Research Site
AlmerÃa
Andalusia
04009
Spain
Research Site
AlmerÃa
Andalusia
04120
Spain
Research Site
Jerez de la Frontera
Andalusia
11407
Spain
Research Site
Donostia / San Sebastian
Basque Country
20014
Spain
Research Site
Barcelona
Catalonia
08003
Spain
Research Site
Santiago de Compostela
Galicia
15706
Spain
Research Site
Madrid
Madrid
28046
Spain
Research Site
Madrid
Madrid, Communidad de
28041
Spain
Research Site
Málaga
Málaga
29011
Spain
Research Site
Catarroja
Valencia
46470
Spain
Research Site
La Eliana, Valencia
Valencia
46183
Spain
Research Site
Valencia
Valencia
46017
Spain
Research Site
Valencia
Valencia
46021
Spain
Research Site
Valencia
Valencia
46022
Spain
Research Site
Valencia
Valencia
46024
Spain
Research Site
Esplugues de Llobregat
Spain
Research Site
Valencia
46010
Spain
Research Site
Valencia
46011
Spain
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
FG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
FG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
FG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
FG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
FG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
FG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
FG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
FG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
FG00079 subjects
FG00181 subjects
FG00280 subjects
FG00380 subjects
FG00440 subjects
FG00540 subjects
FG00682 subjects
FG00778 subjects
FG00881 subjects
FG00979 subjects
Treated
FG00078 subjects
FG00179 subjects
FG00280 subjects
FG00380 subjects
FG00440 subjects
FG00540 subjects
FG00682 subjects
FG00777 subjects
FG00880 subjects
FG00978 subjects
COMPLETED
FG00071 subjects
FG00171 subjects
FG00274 subjects
FG00371 subjects
FG00436 subjects
FG00537 subjects
FG00682 subjects
FG00776 subjects
FG00875 subjects
FG00969 subjects
NOT COMPLETED
FG0008 subjects
FG00110 subjects
FG0026 subjects
FG0039 subjects
FG0044 subjects
FG0053 subjects
FG0060 subjects
FG0072 subjects
FG0086 subjects
FG00910 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0037 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0084 subjects
FG0096 subjects
Lost to Follow-up
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0032 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Intent-to-treat (ITT) population included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
BG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
BG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
BG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
BG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
BG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
BG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
BG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
BG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
BG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00079
BG00181
BG00280
BG00380
BG00440
BG00540
BG00682
BG00778
BG00881
BG00979
BG010720
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Less than (<) 6 months
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00040
BG00136
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Solicited Symptoms After Dose 1
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 1
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00078
OG00179
OG00280
OG003
Title
Denominators
Categories
Any solicited symptom
Title
Measurements
OG00065
OG00168
OG00261
OG003
Primary
Number of Participants With Solicited Symptoms After Dose 2
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 2
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Solicited Symptoms After Dose 3
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
Number
participants
Within 28 days after Dose 3
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 1
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.
Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 2
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
Number
participants
Within 28 days after Dose 3
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 1
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 2
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
Number
participants
Within 28 days after Dose 3
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Primary
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea.
Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 1
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Primary
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea.
Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
Number
participants
Within 28 days after Dose 2
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Primary
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea.
Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
Number
participants
Within 28 days after Dose 3
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Secondary
Number of Participants Who Shed Vaccine-Type Virus
Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.
Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. 'N' (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.
Number
participants
7, 12 and 28 days after Dose 1, 2 and 3
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Secondary
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and 'n' = participants evaluable for specified virus type, for each group, respectively.
Number
95% Confidence Interval
percentage of participants
Day 28 after Dose 3
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Secondary
Genotypic Stability of Recovered Vaccine-Type Virus
Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
Shedding population included all randomized participants who received study vaccine and had valid shedding data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Number
nasal wash samples
Within 28 days after any dose
nasal wash samples
Participants
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Secondary
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
An MA-LRI was a healthcare provider-confirmed diagnosis of 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, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
Safety population included all randomized participants who received study vaccine and had any safety follow-up data.
Number
participants
Day 0 to Day 365
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Secondary
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
Safety population included all randomized participants who received study vaccine and had any safety follow-up data.
Number
participants
Day 0 to Day 365
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Secondary
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.
Safety population included all randomized participants who received study vaccine and had any safety follow-up data.
Number
participants
Day 0 to Day 365
ID
Title
Description
OG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
OG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG002
Time Frame
Day 0 to Day 365
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MEDI-534, Cohort 1
Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
6
78
65
78
EG001
Placebo, Cohort 1
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
5
79
66
79
EG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
5
80
59
80
EG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1
80
55
80
EG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1
40
22
40
EG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
2
40
27
40
EG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
3
82
45
82
EG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
4
77
42
77
EG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
9
80
50
80
EG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
3
78
44
78
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG0030 events0 affected80 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
EG0060 events0 affected82 at risk
EG0070 events0 affected77 at risk
EG0080 events0 affected80 at risk
EG0090 events0 affected78 at risk
Anal abscess
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Measles
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Viral infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0012 events2 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG0030 events0 affected80 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected40 at risk
EG0060 events0 affected82 at risk
EG0070 events0 affected77 at risk
EG0080 events0 affected80 at risk
EG0091 events1 affected78 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Tympanic membrane hyperaemia
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0007 events6 affected78 at risk
EG0014 events4 affected79 at risk
EG0024 events4 affected80 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Eye discharge
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0012 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Eye swelling
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0012 events2 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0023 events1 affected80 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events2 affected78 at risk
EG0011 events1 affected79 at risk
EG0023 events2 affected80 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG00014 events12 affected78 at risk
EG00126 events16 affected79 at risk
EG00223 events17 affected80 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0004 events4 affected78 at risk
EG0011 events1 affected79 at risk
EG0027 events4 affected80 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Intestinal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG00040 events21 affected78 at risk
EG00153 events20 affected79 at risk
EG00244 events22 affected80 at risk
EG003
Tongue geographic
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0009 events8 affected78 at risk
EG00120 events13 affected79 at risk
EG00212 events10 affected80 at risk
EG003
Vomiting projectile
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Feeling hot
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Influenza like illness
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Injection site pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Irritability
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Vaccination site pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Vessel puncture site haemorrhage
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Food allergy
Immune system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0013 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Adenoiditis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Adenoviral conjunctivitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Body tinea
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected78 at risk
EG0013 events3 affected79 at risk
EG0024 events4 affected80 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0023 events3 affected80 at risk
EG003
Candida nappy rash
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Conjunctivitis infective
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Coxsackie viral infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Eczema infected
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Enterovirus infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Furuncle
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0011 events1 affected79 at risk
EG0024 events3 affected80 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0022 events2 affected80 at risk
EG003
Herpangina
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Impetigo
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0013 events2 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Influenza
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0014 events4 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0013 events2 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Omphalitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0015 events4 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Otitis media
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG00016 events11 affected78 at risk
EG00116 events11 affected79 at risk
EG00212 events11 affected80 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0007 events7 affected78 at risk
EG00112 events10 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Paronychia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Pertussis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0004 events4 affected78 at risk
EG0010 events0 affected79 at risk
EG0024 events4 affected80 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0012 events2 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected78 at risk
EG0012 events2 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Scarlet fever
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0004 events4 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Skin candida
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0014 events4 affected79 at risk
EG0025 events4 affected80 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG00019 events15 affected78 at risk
EG00131 events26 affected79 at risk
EG00229 events22 affected80 at risk
EG003
Viral infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0005 events4 affected78 at risk
EG0011 events1 affected79 at risk
EG0024 events4 affected80 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Viral rash
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected78 at risk
EG0015 events5 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Wound infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0003 events1 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Gingival injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0012 events2 affected79 at risk
EG0025 events4 affected80 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0012 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Tongue injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Body temperature increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0009 events6 affected78 at risk
EG0014 events4 affected79 at risk
EG0029 events9 affected80 at risk
EG003
Cardiac murmur
Investigations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Occult blood
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0003 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0005 events5 affected78 at risk
EG0015 events3 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0013 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Laryngeal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events2 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0005 events3 affected78 at risk
EG0011 events1 affected79 at risk
EG0023 events2 affected80 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0014 events3 affected79 at risk
EG0023 events3 affected80 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0011 events1 affected79 at risk
EG0024 events4 affected80 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dandruff
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0012 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0019 events9 affected79 at risk
EG0026 events5 affected80 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0022 events1 affected80 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected78 at risk
EG0013 events3 affected79 at risk
EG0023 events3 affected80 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Periorbital oedema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0007 events7 affected78 at risk
EG0016 events6 affected79 at risk
EG0022 events2 affected80 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected80 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Seborrhoea
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Urticaria papular
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Haematoma
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected80 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Filip Dubovsky, Vice President, Clinical Development
MedImmune, LLC.
301-398-0000
dubovskyf@medimmune.com
3 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0093 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
0
BG00440
BG00540
BG00682
BG00778
BG00881
BG00979
BG010400
6 to <24 months
Title
Measurements
BG00079
BG00181
BG00280
BG00380
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG010320
35
BG00340
BG00421
BG00518
BG00647
BG00741
BG00839
BG00943
BG010360
Male
BG00039
BG00145
BG00245
BG00340
BG00419
BG00522
BG00635
BG00737
BG00842
BG00936
BG010360
80
OG00440
OG00540
OG00682
OG00777
OG00880
OG00978
59
OG00427
OG00524
OG00650
OG00748
OG00860
OG00953
Fever: 100.4 to 101.4 degrees F
Title
Measurements
OG00013
OG0018
OG00210
OG0038
OG0044
OG0054
OG0066
OG0071
OG0084
OG0093
Fever: 101.5 to 103.1 degrees F
Title
Measurements
OG0009
OG0018
OG0026
OG0038
OG0041
OG0053
OG0061
OG0074
OG0082
OG0092
Fever: 103.2 to 104.9 degrees F
Title
Measurements
OG0003
OG0011
OG0021
OG0031
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
Fever: greater than (>) 104.9 degrees F
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Runny/stuffy nose
Title
Measurements
OG00050
OG00151
OG00250
OG00340
OG00419
OG00515
OG00630
OG00736
OG00830
OG00930
Cough
Title
Measurements
OG00027
OG00130
OG00233
OG00324
OG00411
OG0058
OG00619
OG00722
OG00817
OG00919
Drowsiness
Title
Measurements
OG00026
OG00129
OG00221
OG00321
OG00410
OG0059
OG00615
OG00713
OG00816
OG00922
Loss of appetite/decreased urine output
Title
Measurements
OG00022
OG00126
OG00221
OG00321
OG0047
OG0057
OG0069
OG0076
OG00812
OG00912
Irritability/fussiness
Title
Measurements
OG00040
OG00146
OG00241
OG00344
OG00416
OG00514
OG00629
OG00718
OG00841
OG00932
Oropharyngeal inflammation
Title
Measurements
OG0009
OG00112
OG0027
OG0038
OG0042
OG0052
OG0065
OG0077
OG0083
OG0096
Epistaxis
Title
Measurements
OG0004
OG0010
OG0024
OG0035
OG0041
OG0051
OG0062
OG0070
OG0080
OG0091
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00063
OG00165
OG00266
OG00365
OG00425
OG00526
OG00676
OG00771
OG00873
OG00970
Title
Denominators
Categories
Any solicited symptom
Title
Measurements
OG00050
OG00153
OG00253
OG00345
OG00412
OG00519
OG00638
OG00742
OG00839
OG00941
Fever: 100.4 to 101.4 degrees F
Title
Measurements
OG00016
OG00117
OG00210
OG003
Fever: 101.5 to 103.1 degrees F
Title
Measurements
OG00013
OG00110
OG0029
OG003
Fever: 103.2 to 104.9 degrees F
Title
Measurements
OG0002
OG0011
OG0023
OG003
Fever: >104.9 degrees F
Title
Measurements
OG0001
OG0010
OG0020
OG003
Runny/stuffy nose
Title
Measurements
OG00041
OG00135
OG00238
OG003
Cough
Title
Measurements
OG00016
OG00123
OG00228
OG003
Drowsiness
Title
Measurements
OG00020
OG00113
OG00215
OG003
Loss of appetite/decreased urine output
Title
Measurements
OG00016
OG00117
OG00214
OG003
Irritability/fussiness
Title
Measurements
OG00033
OG00129
OG00235
OG003
Oropharyngeal inflammation
Title
Measurements
OG0009
OG0015
OG0024
OG003
Epistaxis
Title
Measurements
OG0004
OG0014
OG0022
OG003
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00060
OG00160
OG00263
OG00361
OG00428
OG00530
OG00676
OG00770
OG00871
OG00968
Title
Denominators
Categories
Any solicited symptom
Title
Measurements
OG00041
OG00145
OG00248
OG00345
OG00420
OG00517
OG00636
OG00733
OG00848
OG00941
Fever: 100.4 to 101.4 degrees F
Title
Measurements
OG0008
OG0019
OG0029
OG003
Fever: 101.5 to 103.1 degrees F
Title
Measurements
OG0006
OG0018
OG0026
OG003
Fever: 103.2 to 104.9 degrees F
Title
Measurements
OG0000
OG0012
OG0022
OG003
Fever: >104.9 degrees F
Title
Measurements
OG0000
OG0010
OG0020
OG003
Runny/stuffy nose
Title
Measurements
OG00036
OG00135
OG00235
OG003
Cough
Title
Measurements
OG00022
OG00114
OG00220
OG003
Drowsiness
Title
Measurements
OG00012
OG0019
OG00211
OG003
Loss of appetite/decreased urine output
Title
Measurements
OG00013
OG00115
OG0028
OG003
Irritability/fussiness
Title
Measurements
OG00023
OG00125
OG00229
OG003
Oropharyngeal inflammation
Title
Measurements
OG0009
OG0014
OG0024
OG003
Epistaxis
Title
Measurements
OG0002
OG0011
OG0022
OG003
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00078
OG00179
OG00280
OG00380
OG00440
OG00540
OG00682
OG00777
OG00880
OG00978
Title
Denominators
Categories
Title
Measurements
OG00051
OG00151
OG00247
OG00335
OG00415
OG00515
OG00620
OG00726
OG00829
OG00921
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00063
OG00165
OG00266
OG00365
OG00425
OG00526
OG00676
OG00771
OG00873
OG00970
Title
Denominators
Categories
Title
Measurements
OG00031
OG00141
OG00231
OG00327
OG0049
OG00510
OG00621
OG00721
OG00825
OG00924
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00060
OG00160
OG00263
OG00361
OG00428
OG00530
OG00676
OG00770
OG00871
OG00968
Title
Denominators
Categories
Title
Measurements
OG00034
OG00135
OG00233
OG00325
OG00411
OG00510
OG00625
OG00722
OG00829
OG00927
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00078
OG00179
OG00280
OG00380
OG00440
OG00540
OG00682
OG00777
OG00880
OG00978
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0082
OG0091
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00063
OG00165
OG00266
OG00365
OG00425
OG00526
OG00676
OG00771
OG00873
OG00970
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0071
OG0080
OG0090
OG002
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00060
OG00160
OG00263
OG00361
OG00428
OG00530
OG00676
OG00770
OG00871
OG00968
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0081
OG0090
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00078
OG00179
OG00280
OG00380
OG00440
OG00540
OG00682
OG00777
OG00880
OG00978
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0024
OG0034
OG0040
OG0050
OG0061
OG0070
OG0080
OG0092
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00063
OG00165
OG00266
OG00365
OG00425
OG00526
OG00676
OG00771
OG00873
OG00970
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0021
OG0033
OG0041
OG0052
OG0060
OG0072
OG0083
OG0091
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00060
OG00160
OG00263
OG00361
OG00428
OG00530
OG00676
OG00770
OG00871
OG00968
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0027
OG0033
OG0042
OG0052
OG0061
OG0071
OG0087
OG0094
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00076
OG00178
OG00278
OG00379
OG00440
OG00540
OG00682
OG00777
OG00878
OG00976
Title
Denominators
Categories
Dose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)
Title
Measurements
OG00033
OG0010
OG00241
OG0030
OG00422
OG0050
OG00650
OG0070
OG00852
OG0090
Dose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)
Title
Measurements
OG00021
OG0010
OG00214
OG003
Dose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)
Title
Measurements
OG0002
OG0010
OG0021
OG003
Dose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)
Title
Measurements
OG0009
OG0010
OG0026
OG003
Dose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)
Title
Measurements
OG0002
OG0010
OG0021
OG003
Dose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)
Title
Measurements
OG0006
OG0010
OG0021
OG003
Dose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Dose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00055
OG00153
OG00251
OG00353
OG00420
OG00522
OG00668
OG00759
OG00863
OG00961
Title
Denominators
Categories
RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)
Title
Measurements
OG00029.5(16.8 to 45.2)
OG00117.6(8.4 to 30.9)
OG00236.0(22.9 to 50.8)
OG00325.5(14.3 to 39.6)
OG00415.8(3.4 to 39.6)
OG0055.3(0.1 to 26.0)
OG0067.4(2.4 to 16.3)
OG0073.4(0.4 to 11.7)
OG0080.0(0.0 to 5.7)
OG0090.0(0.0 to 5.9)
hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)
Title
Measurements
OG00067.3(53.3 to 79.3)
OG0017.5(2.1 to 18.2)
OG00286.3(73.7 to 94.3)
OG003
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00053
OG0010
OG00248
OG0030
OG00429
OG0051
OG00667
OG0070
OG00860
OG0090
nasal wash samples
OG00081
OG0010
OG00267
OG0030
OG004
Title
Denominators
Categories
Genotypically stable
Title
Measurements
OG00077
OG00267
OG00454
OG0051
OG006135
OG008110
Genotypically unstable
Title
Measurements
OG0000
OG0020
OG0040
OG005
Undetermined genotypic stability
Title
Measurements
OG0004
OG0020
OG0045
OG005
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00078
OG00179
OG00280
OG00380
OG00440
OG00540
OG00682
OG00777
OG00880
OG00978
Title
Denominators
Categories
Within 28 days post any dose
Title
Measurements
OG0008
OG0015
OG00212
OG00310
OG0043
OG0054
OG0062
OG0073
OG00810
OG0097
After 28 days post any dose
Title
Measurements
OG00016
OG00116
OG00218
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Units
Counts
Participants
OG00078
OG00179
OG00280
OG00380
OG00440
OG00540
OG00682
OG00777
OG00880
OG00978
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0063
OG0071
OG0081
OG0091
MEDI-534, Cohort 2
Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG003
Placebo, Cohort 2
Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG004
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG005
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
OG006
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG007
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
OG008
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
OG009
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.