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NCT02247726 · ClinicalTrials.gov registry record · Phase 2

RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.

A Phase 2 study of Respiratory Syncytial Virus Infections, sponsored by Novavax.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target
7
Study locations

NCT02247726 is a Phase 2 study of Respiratory Syncytial Virus Infections that has completed, run by Novavax. The registered enrollment target is 50 participants, below the 1,089-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT02247726, a Phase 2 study of Respiratory Syncytial Virus Infections, has completed, sponsored by Novavax.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target
7
Study locations

Study Summary

The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.

Interventions

  • DRUG Saline Placebo (0.5mL injection)
  • DRUG RSV F vaccine (0.5mL injection)

Study Locations (7)

Kansas

  • Hutchinson Clinic, P.A. - Hutchinson
  • University of Kansas Medical Center Research Institute - Kansas City

Idaho

  • Advanced Specialty Research - Nampa

Nebraska

  • Meridian Clinical Research - Norfolk

North Carolina

  • Duke University - Durham

Pennsylvania

  • Magee- Womens Hospital of UPMC - Pittsburgh

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-09
Est. Completion 2016-07
Phase Phase 2

Sponsor

Novavax

31 total trials

What the Registry Record Tells You About NCT02247726

The ClinicalTrials.gov registry entry for NCT02247726 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,089-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (95% lower). The listed sponsor is Novavax, which has 31 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 2 interventions - of which Saline Placebo (0.5mL injection) is the first listed.

NCT02247726 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Kansas, Idaho, Nebraska.

Frequently Asked Questions

What is clinical trial NCT02247726 about?

NCT02247726 is a clinical study titled "RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.". The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.

What is the current status of trial NCT02247726?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2014-09. Estimated completion is 2016-07.

What conditions does trial NCT02247726 study?

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

What interventions are being tested in trial NCT02247726?

The interventions under investigation include: Saline Placebo (0.5mL injection) (DRUG), RSV F vaccine (0.5mL injection) (DRUG).

Who is sponsoring clinical trial NCT02247726?

This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02247726 being conducted?

This trial has 7 study locations across Idaho, Kansas, Nebraska, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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