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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00493285 |
Purpose
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of RSV and PIV3 disease in young infants.
| Condition | Intervention | Phase |
|---|---|---|
|
Respirovirus Infections Respiratory Syncytial Virus Infections Parainfluenza Virus 3, Human |
Biological: MEDI-534 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age |
| Estimated Enrollment: | 49 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
MEDI-534 at 10:4 TCID50 at 0, 2, and 4 months (Nasal spray)
|
Biological: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 to 4, 10 to 5, or 10 to 6 TCID50
|
|
2: Active Comparator
MEDI-534 at 10:5 TCID50 at 0, 2, and 4 months (Nasal Spray)
|
Biological: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 to 4, 10 to 5 or 10 to 6 TCID50.
|
|
3: Active Comparator
MEDI-534 at 10:6 TCID50 at 0, 2, and 4 months (Nasal Spray)
|
Biological: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 to 4, 10 to 5 or 10 to 6 TCID50.
|
The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10 to 4, 10 to 5, or 10 to 6 TCID50 when administered to RSV and PIV3 seronegative children 6 to <24 months of age.
Eligibility| Ages Eligible for Study: | 6 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Tufts-New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Nebraska | |
| Meridian Clinical Research, LLC | |
| Omaha, Nebraska, United States, 68134 | |
| United States, New York | |
| Withrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Mercy Children's Hospital, St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Tennessee | |
| Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Study Director: | Elissa Malkin, D.O. | MedImmune LLC |
More Information
| Responsible Party: | MedImmune LLC ( Elissa Malkin, D.O. ) |
| Study ID Numbers: | MI-CP149 |
| Study First Received: | June 26, 2007 |
| Last Updated: | July 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00493285 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lower Respiratory Tract Illness RSV and PIV3 infection |
|
Virus Diseases Communicable Diseases Pneumovirus Infections RNA Virus Infections Paramyxoviridae Infections |
Respirovirus Infections Respiratory Syncytial Virus Infections Infection Mononegavirales Infections |