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Evaluation of the Safety and Immunogenicity of a Live Attenuated Human Metapneumovirus Vaccine

NCT01255410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-12-15

No results posted yet for this study

Summary

People who are infected with human metapneumovirus (HMPV) may develop upper and lower respiratory illnesses. Children are particularly sensitive to HMPV infection. This study will evaluate the safety and immune response of an HMPV vaccine in healthy adults, HMPV-seropositive children, and HMPV-seronegative infants and children.

Conditions

  • Metapneumovirus

Interventions

BIOLOGICAL

10^6 PFU rHMPV-Pa vaccine

Single dose of 10\^6 PFU rHMPV-Pa vaccine delivered intranasally

BIOLOGICAL

10^5 PFU rHMPV-Pa vaccine

Single dose of 10\^5 PFU rHMPV-Pa vaccine delivered intranasally

BIOLOGICAL

Placebo Vaccine

Single dose of placebo vaccine delivered intranasally

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ruth A. Karron, MD · Johns Hopkins Bloomberg School of Public Health

  • Janet Englund, MD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-10-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01255410 on ClinicalTrials.gov