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

NCT00686075 | Completed Phase 1 Results

• 1 other identifier: MI-CP178
• Study Type: interventional
• Target: 1,338
• Locations: 9 countries
• Sites: 100

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.

Conditions

Healthy

Keywords

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

  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

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

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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 2 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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
• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (100)

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Mobile, Alabama, United States

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Bentonville, Arkansas, 72712, United States

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Little Rock, Arkansas, 72202, United States

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Anaheim, California, 92801, United States

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Anaheim, California, United States

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Bell Gardens, California, 90201, United States

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Downey, California, 90241, United States

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Lakewood, California, 90712, United States

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Long Beach, California, United States

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Paramount, California, 90723, United States

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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

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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

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Valencia, 46010, Spain

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Valencia, 46011, Spain

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Related Publications (1)

• 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.

  PMID: 23602668 DERIVED

Results Point of Contact

• Title: Filip Dubovsky, Vice President, Clinical Development
• Organization: MedImmune, LLC.

dubovskyf@medimmune.com

301-398-0000

Study Officials

• Elissa Malkin, D.O.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 29, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 26, 2014
• Results First Posted: September 26, 2014

Record last verified: 2014-09

Locations

IL (1); CA (2); US (51); BR (7); DE (3); FI (9); ZA (4); ES (19); AU (4)