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COMPLETED Phase 2

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

NCT02247726 · View on ClinicalTrials.gov ↗

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

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02247726

The ClinicalTrials.gov registry entry for NCT02247726 describes a study currently listed as completed. It is categorized as Phase 2, 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 8 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 2 interventions — of which Saline Placebo (0.5mL injection) 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: NCT02247726 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Kansas, Idaho, Nebraska. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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

Who is sponsoring clinical trial NCT02247726?

This trial is sponsored by Novavax, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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