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

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ClinicalTrials.gov Identifier: NCT01192958
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : September 1, 2010
Information provided by:
Public Health England

Brief Summary:
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 or disease
H1N1 Virus

Study Type : Observational
Observational Model: Case-Only
Official Title: A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza
Study Start Date : January 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Information from the National Library of Medicine

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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.

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  • Withdrawn from clinical service evaluation of novel H1N1v vaccine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.

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

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

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs