Study identifier:MI-CP178
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy
Phase 1/2
Yes
-
All
1338
Interventional
2 Months - 23 Months
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2014 by MedImmune, LLC
MedImmune, LLC
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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.
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.
Location
Location
Bentonville, AR, United States, 72712
Location
Sellersville, PA, United States, 18960
Location
West Covina, CA, United States, 91790
Location
Brooklyn, NY, United States
Location
Midlothian, VA, United States, 23113
Location
Lexington, KY, United States, 40503
Location
Jackson, TN, United States, 38305
Location
Dalton, GA, United States, 30721
Arms | Assigned Interventions |
---|---|
Experimental: MEDI-534, Cohort 1 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/Vaccine: MEDI-534, Cohort 1 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. |
Placebo Comparator: Placebo, Cohort 1 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 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. |
Experimental: MEDI-534, Cohort 2 Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. | Biological/Vaccine: MEDI-534, Cohort 2 Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
Placebo Comparator: Placebo, Cohort 2 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 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. |
Experimental: MEDI-534, Cohort 3 Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. | Biological/Vaccine: MEDI-534, Cohort 3 Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. |
Placebo Comparator: Placebo, Cohort 3 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 Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. |
Experimental: MEDI-534, Cohort 4 Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. | Biological/Vaccine: MEDI-534, Cohort 4 Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. |
Placebo Comparator: Placebo, Cohort 4 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 Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. |
Experimental: MEDI-534, Cohort 5 Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. | Biological/Vaccine: MEDI-534, Cohort 5 Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
Placebo Comparator: Placebo, Cohort 5 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 Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
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