NCT00246480

Brief Summary

Respiratory syncytial virus (RSV) causes sickness and deaths in older people every winter. This study will investigate how aging affects the body's immune response (body's response to disease) to RSV. About 2000 people, age 21 and older, who reside in the upstate NY area, will be recruited. Two groups of subjects will be studied. The 1st group of volunteers will be recruited prior to the start of RSV season in year 1 of the study. These volunteers will include healthy people and people with various medical conditions. The 2nd group of volunteers will be patients admitted to Rochester General Hospital for acute respiratory illness. Procedures will include drawing blood from a vein in the arm (2 tablespoons), collecting nasal swabs, and collecting sputum. Volunteers may participate in study related procedures for up to 3 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2008

Completed
Last Updated

February 4, 2019

Status Verified

April 1, 2011

Enrollment Period

2.7 years

First QC Date

October 27, 2005

Last Update Submit

January 31, 2019

Conditions

Keywords

Respiratory Syncytial Virus Infections, RSV, elderly

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prospective Cohort
  • Greater than or equal to 21 years of age
  • Able to provide written consent
  • Telephone contact available
  • Will reside in the Upstate New York area throughout the winter months
  • Hospital Cohort
  • Greater than or equal to 21 years of age
  • Able to provide written consent or legal guardian able to provide written consent
  • Telephone contact available
  • Symptoms of respiratory tract infection for less than or equal to 30 days duration. Symptoms can be all or any of the following: nasal congestion, cough, new or increased sputum or dyspnea, sore throat, with or without fever

You may not qualify if:

  • Prospective Cohort
  • Known immunosuppressive condition including: HIV, active cancer currently receiving chemotherapy, hematological malignancy, autoimmune disorders.
  • Documented RSV infection in the previous year
  • Participation in previous RSV vaccine study
  • Hospital Cohort
  • Known immunosuppressive condition including: HIV, active cancer currently receiving chemotherapy, hematological malignancy, autoimmune disorders.
  • Symptoms of a respiratory infection for longer than 30 days.
  • Participation in prior RSV vaccine study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rochester General Hospital

Rochester, New York, 14621, United States

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsRespiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesPneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

October 3, 2005

Primary Completion

May 28, 2008

Study Completion

May 28, 2008

Last Updated

February 4, 2019

Record last verified: 2011-04

Locations