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Melanotan-I

Afamelanotide, MT-I, [Nle4-D-Phe7]-α-MSH, Scenesse, CUV-1647

Quick Stats
Studies 225
Trials 100
Completed PHASE1 INTERVENTIONAL NCT00345670

Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.

Detailed Description

This is a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for RSV and PIV3 at screening. MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to three cohorts of subjects in a staggered, step-wise fashion. A single dose of study vaccine (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal spray, one-half dose into each nostril. The target sample size is 120 subjects randomized 1:1 (MEDI-534 to placebo), with 40 subjects in each of three cohorts. Randomization will be stratified by site. This study will enroll during the RSV off season at multiple sites in the United States and Chile.

Interventions

Name: MEDI-534
Type: BIOLOGICAL
Description: 10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
Name: MEDI-534
Type: BIOLOGICAL
Description: 10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
Name: MEDI-534
Type: BIOLOGICAL
Description: 10:6 TCID50 of MEDI-534; intranasal spray

Primary Outcomes

Measure: To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
TimeFrame: Day 28
Description:
Measure: Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing
TimeFrame: Day 28 post final vaccination
Description:
Measure: Adverse events (AEs) from administration of study vaccine through 28 post-dosing
TimeFrame: Day 28 post final vaccination
Description:
Measure: Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing
TimeFrame: Day 180
Description:

Trial Information

NCT ID

NCT00345670

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

MedImmune LLC

Last Updated

December 15, 2025