NCT00686075

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,338 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 2 Months – 23 Months
• Healthy volunteers: Accepted

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

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	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.
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.
BIOLOGICAL	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.
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.
BIOLOGICAL	MEDI-534, Cohort 3	Participants aged 2 months will receive 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.
BIOLOGICAL	MEDI-534, Cohort 4	Participants aged 2 months will receive 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.
BIOLOGICAL	MEDI-534, Cohort 5	Participants aged 2 months will receive 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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-05-29
• Last updated: 2014-09-26
• Results posted: 2014-09-26

Locations

100 sites across 9 countries: United States, Australia, Brazil, Canada, Finland, Germany, Israel, South Africa, Spain