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COMPLETED Phase 1

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age

NCT02794870 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 311.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL RSV LID ΔM2-2 1030s vaccine

Study Locations (8)

California

  • University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program — La Jolla
  • Usc La Nichd Crs — Los Angeles

Illinois

  • Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago
  • Lurie Children's Hospital of Chicago (LCH) CRS — Chicago

New York

  • SUNY Stony Brook NICHD CRS — Stony Brook
  • Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx

Colorado

  • Univ. of Colorado Denver NICHD CRS — Aurora

Maryland

  • Johns Hopkins University Center for Immunization Research — Baltimore

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2016-07-15
Est. Completion 2017-07-07
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02794870

The ClinicalTrials.gov registry entry for NCT02794870 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 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 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 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: NCT02794870 reports 8 study locations spanning 5 distinct geographic areas — top geographies include California, Illinois, New York. 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 NCT02794870 about?

NCT02794870 is a clinical study titled "Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age". The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 311.

What is the current status of trial NCT02794870?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2016-07-15. Estimated completion is 2017-07-07.

What conditions does trial NCT02794870 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 NCT02794870?

The interventions under investigation include: Placebo (BIOLOGICAL), RSV LID ΔM2-2 1030s vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02794870?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02794870 being conducted?

This trial has 8 study locations across California, Colorado, Illinois, 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