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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:
Information provided by:
Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT01192958
First received: August 31, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  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:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Health Protection Agency, United Kingdom:

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

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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  • Withdrawn from clinical service evaluation of novel H1N1v vaccine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

No publications provided

Responsible Party: Professor Liz Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT01192958     History of Changes
Other Study ID Numbers: OFLU
Study First Received: August 31, 2010
Last Updated: August 31, 2010
Health Authority: UK: London - Surrey Borders Research Ethics Committee

Keywords provided by Health Protection Agency, United Kingdom:
swine flu
novel h1n1v
novel h1n1
h1n1

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 17, 2012