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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading sy

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
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT02794870 record still lists

NCT02794870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,090-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (97% lower).

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 lists 8 locations in 5 states (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.

Learn More About Clinical Trials

Similar trials for Respiratory Syncytial Virus Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02794870's enrollment target sits among peer trials

33 21st of 21 higher than 1 of 21 other Respiratory Syncytial Virus Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02794870, the US trial registry maintained by the National Library of Medicine. NCT02794870 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.