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A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza (Snuffles)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192958
First Posted: September 1, 2010
Last Update Posted: September 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Public Health England
  Purpose
At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. If such a test were available, this painless and non invasive test will improve direct clinical care to an individual as well as significantly help guide future public health management of the pandemic.

Condition
H1N1 Virus

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza

Resource links provided by NLM:


Further study details as provided by Public Health England:

Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects from primary care who are participating in the clinical service evaluation.
Criteria

Inclusion Criteria:

  • Participants of the clinical service evaluation of novel H1N1v vaccine
  • First or second blood sample for the clinical service evaluation successfully collected

Exclusion Criteria:

  • Withdrawn from clinical service evaluation of novel H1N1v vaccine
  • Second blood sample for the clinical service evaluation not collected.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Professor Liz Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT01192958     History of Changes
Other Study ID Numbers: OFLU
First Submitted: August 31, 2010
First Posted: September 1, 2010
Last Update Posted: September 1, 2010
Last Verified: December 2009

Keywords provided by Public Health England:
swine flu
novel h1n1v
novel h1n1
h1n1

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs