A Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 Hemagglutinin (HA) Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GlaxoSmithKline (GSK) Biologicals' Pandemic Influenza Vaccines

Completed

Conditions studied: Immunologic Tests

In brief

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.

Key facts

Study ID

NCT02415842

Run by

GlaxoSmithKline

People needed

414

Starts

2015-10-26

Expected to finish

2018-02-16

Last updated by the study team

2019-07-23

Who can join

Age: 1 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — New York, New York, United States

Full record on ClinicalTrials.gov

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