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NCT00641017 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine

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

Completed
Registry status
Phase 1
Development phase
87
Enrollment target

NCT00641017 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 87 participants.

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The verdict

NCT00641017, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
87 participants
Enrollment target

Study Summary

Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2008-03
Est. Completion 2012-07
Phase Phase 1

What the Registry Record Tells You About NCT00641017

The ClinicalTrials.gov registry entry for NCT00641017 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 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 2,006 total studies on file at ClinicalTrials.gov.

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

NCT00641017 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00641017 about?

NCT00641017 is a clinical study titled "Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine". Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and i...

What is the current status of trial NCT00641017?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2008-03. Estimated completion is 2012-07.

What interventions are being tested in trial NCT00641017?

The interventions under investigation include: Placebo (BIOLOGICAL), rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00641017?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.