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
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
This date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)
Study Completion
August 2012
Actual (reported)
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
1,338 participants
Study completion date
August 2012
Actual (reported)
Listed locations
9 countries · 100 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
May 23, 2008
Actual (reported)
First Posted
May 29, 2008
Actual (reported)
Study Start
June 2008
Date type not reported
This date has not been verified as actual or estimated.
Respiratory Syncytial Virus (RSV)Parainfluenza Virus Type 3 (PIV3)MEDI-534
Outcome Measures
Primary Outcomes (12)
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
Secondary Outcomes (6)
Number of Participants Who Shed Vaccine-Type Virus
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
Day 28 after Dose 3
Genotypic Stability of Recovered Vaccine-Type Virus
Within 28 days after any dose
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
Day 0 to Day 365
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
Day 0 to Day 365
+1 more secondary outcomes
Study Arms (10)
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.
Interventions
MEDI-534, Cohort 1Biological
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.
MEDI-534, Cohort 1
Placebo, Cohort 1Other
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
Eligibility Criteria
Age2 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
You may qualify if:
Male or female whose age on the day of randomization falls within one of the two age groups:
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
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.
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.
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
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.
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 2Biological
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 2Other
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 3Biological
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 3Other
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 4Biological
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 4Other
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 5Biological
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 5Other
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
You may not qualify if:
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
+7 more criteria
Contact the study team to confirm eligibility.
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
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West Covina, California, 91790, United States
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Thornton, Colorado, United States
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Gainesville, Florida, 32607, United States
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Tampa, Florida, 33606, United States
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Dalton, Georgia, 30721, United States
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Chicago, Illinois, 60614, United States
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Kansas City, Kansas, United States
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Topeka, Kansas, 66604, United States
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Lexington, Kentucky, 40503, United States
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Paducah, Kentucky, 42003, United States
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Shreveport, Louisiana, United States
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Saint Paul, Minnesota, 55108, United States
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Bridgeton, Missouri, 63044, United States
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Omaha, Nebraska, 68131, United States
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Omaha, Nebraska, 68134, United States
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Las Vegas, Nevada, United States
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Brooklyn, New York, United States
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Johnson City, New York, United States
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Lake Success, New York, 11042, United States
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Stony Brook, New York, 11794-8111, United States
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Syracuse, New York, 13210, United States
Research Site
New Bern, North Carolina, 28562, United States
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Cincinnati, Ohio, 45229, United States
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Gresham, Oregon, 97030, United States
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Pittsburgh, Pennsylvania, United States
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Sellersville, Pennsylvania, 18960, United States
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Jackson, Tennessee, 38305, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, 77030, United States
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Poteet, Texas, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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San Antonio, Texas, United States
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Tomball, Texas, 77070, United States
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Layton, Utah, 84041, United States
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Orem, Utah, 84058, United States
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St. George, Utah, 84790, United States
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Midlothian, Virginia, 23113, United States
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Huntington, West Virginia, 25701, United States
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Garran, Australian Capital Territory, 2605, Australia
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Herston, Queensland, 4006, Australia
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North Adelaide, South Australia, 5006, Australia
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Subiaco, Western Australia, 6008, Australia
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Passo Fundo-RS, Rio Grande do Sul, 99010, Brazil
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São Paulo, São Paulo, 05437-010, Brazil
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Porto Alegre - RS, Brazil
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Porto Alegre/RS, 90035-903, Brazil
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Ribeirao Preto - SP, 14048-990, Brazil
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Sao Paulo - SP, Brazil
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São Paulo, 01221-020, Brazil
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Brampton, Ontario, L6W3E1, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Helsinki, FI-00930, Finland
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Jarvenpaa, 04400, Finland
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Kokkola, FI-67100, Finland
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Kuopio, FI-70211, Finland
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Lahti, FI-15140, Finland
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Oulu, FI-90220, Finland
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Pori, FI-28100, Finland
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Tampere, 33100, Finland
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Turku, FI-20520, Finland
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Berlin, 10365, Germany
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Freiburg im Breisgau, 79106, Germany
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Mainz, Germany
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Netanya, Israel
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Johannesburg, Gauteng, 2013, South Africa
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Pretoria, Gauteng, 0001, South Africa
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Belle Ville Cape Town, Western Cape, 7530, South Africa
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Cape Town, Western Cape, 7824, South Africa
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Almería, Andalusia, 04007, Spain
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Almería, Andalusia, 04009, Spain
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Almería, Andalusia, 04120, Spain
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Jerez de la Frontera, Andalusia, 11407, Spain
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Donostia / San Sebastian, Basque Country, 20014, Spain
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Barcelona, Catalonia, 08003, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, Communidad de, 28041, Spain
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Málaga, Málaga, 29011, Spain
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Catarroja, Valencia, 46470, Spain
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La Eliana, Valencia, Valencia, 46183, Spain
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Valencia, Valencia, 46017, Spain
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Valencia, Valencia, 46021, Spain
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Valencia, Valencia, 46022, Spain
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Valencia, Valencia, 46024, Spain
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Esplugues de Llobregat, Spain
Research Site
Valencia, 46010, Spain
Research Site
Valencia, 46011, Spain
Primary Completion
August 2012
Actual (reported)
Study Completion
August 2012
Actual (reported)
Last Updated
September 26, 2014
Results First Posted
September 26, 2014
Record last verified: 2014-09
Source record
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Source: ClinicalTrials.gov.
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