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COMPLETED 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

NCT02927873 · View on ClinicalTrials.gov ↗

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.

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

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02927873

The ClinicalTrials.gov registry entry for NCT02927873 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02927873 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02927873?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial