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NCT02927873 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants

A Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
107
Enrollment target
20
Study locations

NCT02927873 is a Phase 1 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 107 participants, below the 1,086-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02927873, a Phase 1 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
107 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Conditions Studied

Respiratory Syncytial Virus Infections

Interventions

  • DRUG Placebo
  • BIOLOGICAL RSV (GSK3389245A) low dose formulation vaccine
  • BIOLOGICAL RSV (GSK3389245A) middle dose formulation vaccine
  • BIOLOGICAL RSV (GSK3389245A) high dose formulation vaccine

Study Locations (20)

Other

  • GSK Investigational Site - México
  • GSK Investigational Site - Panama City
  • GSK Investigational Site - Dębica
  • GSK Investigational Site - Burgos
  • GSK Investigational Site - Madrid
  • GSK Investigational Site - Madrid
  • GSK Investigational Site - Madrid
  • GSK Investigational Site - Majadahonda (Madrid)
  • GSK Investigational Site - Santiago de Compostela
  • GSK Investigational Site - Valencia

California

  • GSK Investigational Site - Anaheim

Colorado

  • GSK Investigational Site - Aurora

Kansas

  • GSK Investigational Site - Topeka

Maryland

  • GSK Investigational Site - Frederick

New York

  • GSK Investigational Site - Syracuse

South Dakota

  • GSK Investigational Site - Sioux Falls

Nova Scotia

  • GSK Investigational Site - Halifax

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2017-01-11
Est. Completion 2020-11-26
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT02927873

The ClinicalTrials.gov registry entry for NCT02927873 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,086-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (90% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 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 4 interventions - of which Placebo is the first listed.

NCT02927873 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT02927873 about?

NCT02927873 is a clinical study titled "A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants". The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

What is the current status of trial NCT02927873?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2017-01-11. Estimated completion is 2020-11-26.

What conditions does trial NCT02927873 study?

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

What interventions are being tested in trial NCT02927873?

The interventions under investigation include: Placebo (DRUG), RSV (GSK3389245A) low dose formulation vaccine (BIOLOGICAL), RSV (GSK3389245A) middle dose formulation vaccine (BIOLOGICAL), RSV (GSK3389245A) high dose formulation vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02927873?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02927873 being conducted?

This trial has 20 study locations across California, Colorado, Kansas, 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.