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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vacci

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 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 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.
Sponsor: MedImmune LLC

Current Primary Outcome:

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


Original Primary Outcome:

  • To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
  • Reactogenicity Evals (REs)from administration of study vaccine through 28 days post-dosing
  • Adverse events (AEs) from administration of study vaccine through 28 post-dosing
  • Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing


Current Secondary Outcome:

  • To describe the immunogenicity and viral shedding of MEDI-534 [ Time Frame: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits. ]
  • The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples [ Time Frame: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits. ]


Original Secondary Outcome:

  • To describe the immogenicity and viral shedding of MEDI-534
  • The immunogenicity of MEDI-534 will be assessed by serum antibody response to RSV and PIV3
  • The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples
  • The secondary safety and tolerability of MEDI-534 will be assessed by SAEs and SNMCs


Information By: MedImmune LLC

Dates:
Date Received: June 27, 2006
Date Started: June 2006
Date Completion:
Last Updated: September 2, 2008
Last Verified: September 2008