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NCT02794870 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age

A Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
33
Enrollment target
8
Study locations

NCT02794870 is a Phase 1 study of Respiratory Syncytial Virus Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 33 participants, below the 1,090-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (97% lower). The trial reports 8 study locations across 5 states.

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The verdict

NCT02794870, a Phase 1 study of Respiratory Syncytial Virus Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target
8
Study locations

Study Summary

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 311.

Conditions Studied

Respiratory Syncytial Virus Infections

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL RSV LID ΔM2-2 1030s vaccine

Study Locations (8)

California

  • University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program - La Jolla
  • Usc La Nichd Crs - Los Angeles

Illinois

  • Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
  • Lurie Children's Hospital of Chicago (LCH) CRS - Chicago

New York

  • SUNY Stony Brook NICHD CRS - Stony Brook
  • Jacobi Med. Ctr. Bronx NICHD CRS - The Bronx

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Maryland

  • Johns Hopkins University Center for Immunization Research - Baltimore

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2016-07-15
Est. Completion 2017-07-07
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT02794870

The ClinicalTrials.gov registry entry for NCT02794870 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,090-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (97% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02794870 reports 8 study locations spanning 5 distinct geographic areas - top geographies include California, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT02794870 about?

NCT02794870 is a clinical study titled "Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age". The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 311.

What is the current status of trial NCT02794870?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2016-07-15. Estimated completion is 2017-07-07.

What conditions does trial NCT02794870 study?

This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.

What interventions are being tested in trial NCT02794870?

The interventions under investigation include: Placebo (BIOLOGICAL), RSV LID ΔM2-2 1030s vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02794870?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02794870 being conducted?

This trial has 8 study locations across California, Colorado, Illinois, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.