New York, New York 10029


Purpose:

The purpose of this exploratory, retrospective laboratory study is to assess the humoral immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes following administration, in adults and children, of GSK Biologicals' adjuvanted and unadjuvanted pandemic influenza vaccines, using archived serum samples from previously completed clinical trials.


Criteria:

Inclusion Criteria: Not applicable since no subjects will be actively enrolled in this study; only the sera samples of the subjects who were a part of previously conducted primary trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study: - Subjects who received two doses of influenza vaccine 21 days apart and were included in the ATP cohort for immunogenicity and Persistence cohort (depending on the study) in the primary studies listed. - Subjects who had agreed that their blood samples could be used for further research while giving informed consent for any of the primary studies listed. - Subjects who have sufficient residual sample volume (i.e., ≥0.5 mL) of serum at all time points. - Subjects with vaccine homologous neutralizing antibody result available at Day 0 and at 21 (25 samples available per group in Study H9N2-001) Exclusion Criteria: - Not applicable since no subjects will be actively enrolled in this study; only the serum samples of the subjects who were a part of previously conducted trials will be used for testing.


NCT ID:

NCT02415842


Primary Contact:

Study Director
GSK Clinical Trials
GlaxoSmithKline

US GSK Clinical Trials Call Center
Phone: 877-379-3718
Email: GSKClinicalSupportHD@gsk.com


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States

US GSK Clinical Trials Call Center
Phone: 877-379-3718
Email: GSKClinicalSupportHD@gsk.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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