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NCT03674177 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
502
Enrollment target

NCT03674177 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 502 participants.

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The verdict

NCT03674177, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
502 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.

Interventions

  • DRUG Placebo (Normal Saline)
  • BIOLOGICAL GSK3888550A RSV Maternal vaccine formulation 1
  • BIOLOGICAL GSK3888550A RSV Maternal vaccine formulation 2
  • BIOLOGICAL GSK3888550A RSV Maternal vaccine formulation 3

Trial Details

FieldValue
Enrollment Target 502 participants
Start Date 2018-10-30
Est. Completion 2019-09-02
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT03674177

The ClinicalTrials.gov registry entry for NCT03674177 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 502 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo (Normal Saline) is the first listed.

NCT03674177 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03674177 about?

NCT03674177 is a clinical study titled "A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women". The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study...

What is the current status of trial NCT03674177?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 502 participants. The study started on 2018-10-30. Estimated completion is 2019-09-02.

What interventions are being tested in trial NCT03674177?

The interventions under investigation include: Placebo (Normal Saline) (DRUG), GSK3888550A RSV Maternal vaccine formulation 1 (BIOLOGICAL), GSK3888550A RSV Maternal vaccine formulation 2 (BIOLOGICAL), GSK3888550A RSV Maternal vaccine formulation 3 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03674177?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.