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Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

NCT02040831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-12-21

No results posted yet for this study

Summary

Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children.

This study is a companion study to IMPAACT 2000.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV LID ΔM2-2 Vaccine

10\^5.0 plaque forming units (PFU); 0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)

BIOLOGICAL

Placebo Vaccine

0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ruth A. Karron, MD · Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

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 NCT02040831 on ClinicalTrials.gov