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

NCT ID: NCT01192958

Last Updated: 2010-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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H1N1 Virus

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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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* Withdrawn from clinical service evaluation of novel H1N1v vaccine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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health England

OTHER_GOV

Sponsor Role lead

Responsible Party

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Health Protection Agency

Other Identifiers

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OFLU

Identifier Type: -

Identifier Source: org_study_id

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