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Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

NCT01968083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-07-26

No results posted yet for this study

Summary

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV cps2 Vaccine

10\^5.3 plaque forming units (PFUs) or RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

BIOLOGICAL

Placebo Vaccine

Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Coleen K. Cunningham, MD · Chief, Pediatric Infectious Diseases; T915, Children's Health Center

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
2013-10-03
Primary Completion
2015-05-31
Completion
2015-05-31

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 NCT01968083 on ClinicalTrials.gov