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NCT03473002 · ClinicalTrials.gov registry record · Phase 1

A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults

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

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT03473002: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT03473002 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03473002, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of a single intranasal dose of Sendai virus vectored Respiratory Syncytial Virus (SeVRSV) vaccine. The subjects will be randomized in a 4:1 ratio to receive SeVRSV vaccine at a dose of 1 x 10\^7 EID50 or placebo (saline) intranasally. Study duration is approximately 11 months with subject participation duration approximately 6 months. The primary objectives are to: 1) assess the safety and reactogenicity of SeVRSV vaccine following receipt of one intranasal dose; 2) assess the ELISA antibody responses to SeV and to the RSV F protein at 28 days post receipt of one intranasal dose of SeVRSV vaccine; 3) assess the detection of vaccine virus from nasal washes at days 3, 5, 8 and 15 following receipt of one intranasal dose of SeVRSV vaccine.

Interventions

  • OTHER Placebo
  • BIOLOGICAL SeVRSV Vaccine

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2018-05-16
Est. Completion 2019-02-14
Phase Phase 1

What the finished NCT03473002 record still lists

NCT03473002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03473002 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03473002 about?

NCT03473002 is a clinical study titled "A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults". This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of a single intranasal...

What is the current status of trial NCT03473002?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-05-16. Estimated completion is 2019-02-14.

What interventions are being tested in trial NCT03473002?

The interventions under investigation include: Placebo (OTHER), SeVRSV Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03473002?

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

How this trial's enrollment target compares

Where NCT03473002's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03473002, the US trial registry maintained by the National Library of Medicine. NCT03473002 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.