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

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

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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.

Primary Outcome

Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

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
GlaxoSmithKline

1,345 total trials

What the finished NCT02927873 record still lists

NCT02927873 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 1,086-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (90% lower).

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 names 20 study sites across 11 states, led by 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.

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 NCT02927873's enrollment target sits among peer trials

107 17th of 21 higher than 5 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 NCT02927873, the US trial registry maintained by the National Library of Medicine. NCT02927873 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.