CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,338 enrolled
Drug / intervention
MEDI-534, Cohort 1 +9 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00686075
NCT00686075Phase 2Completed
CompareCT.gov

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

MedImmune LLC·interventional·Posted May 29, 2008·Updated Sep 26, 2014

In Brief

A Phase 2 clinical trial evaluating MEDI-534, Cohort 1, Placebo, Cohort 1, and 8 other interventions for Healthy. Completed, enrolled 1,338 participants across 100 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesAustralia, Brazil, Canada, Finland, Germany, Israel, South Africa, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2008
Enrollment StartJun 1, 2008
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.1 years ago

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.

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.

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.

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.

MEDI-534, Cohort 3biological

Participants aged 2 months will receive MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

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.

MEDI-534, Cohort 4biological

Participants aged 2 months will receive MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 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.

MEDI-534, Cohort 5biological

Participants aged 2 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

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.