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NCT02040831 · ClinicalTrials.gov registry record · Phase 1

Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

A Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
3
Enrollment target
1
Study location

NCT02040831 is a Phase 1 study of Respiratory Syncytial Virus Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3 participants, below the 1,091-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02040831, a Phase 1 study of Respiratory Syncytial Virus Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children. This study is a companion study to IMPAACT 2000.

Interventions

  • BIOLOGICAL RSV LID ΔM2-2 Vaccine
  • BIOLOGICAL Placebo Vaccine

Study Locations (1)

Maryland

  • Center for Immunization Research, JHU - Baltimore

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2014-09
Est. Completion 2015-04
Phase Phase 1

What the Registry Record Tells You About NCT02040831

The ClinicalTrials.gov registry entry for NCT02040831 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,091-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 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 RSV LID ΔM2-2 Vaccine is the first listed.

NCT02040831 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02040831 about?

NCT02040831 is a clinical study titled "Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children". Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children. This study is a companion study to IMPAACT 2000.

What is the current status of trial NCT02040831?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-09. Estimated completion is 2015-04.

What conditions does trial NCT02040831 study?

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

What interventions are being tested in trial NCT02040831?

The interventions under investigation include: RSV LID ΔM2-2 Vaccine (BIOLOGICAL), Placebo Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02040831?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02040831 being conducted?

This trial has 1 study location across Maryland. 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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