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NCT02415842 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 414
- Enrollment target
NCT02415842: Completed study, sponsored by GlaxoSmithKline.
NCT02415842 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 414 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415842 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 414 participants
- Enrollment target
Study Summary
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.
Primary Outcome
With respect to samples from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Eli
Interventions
- OTHER Serum samples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2015-10-26 |
| Est. Completion | 2018-02-16 |
What the finished NCT02415842 record still lists
NCT02415842 is an observational study that tracks outcomes without assigning an intervention. The registered 414 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Serum samples is the first listed.
NCT02415842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415842 about?
NCT02415842 is a clinical study titled "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". 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 ...
What is the current status of trial NCT02415842?
This trial is currently completed. The enrollment target is 414 participants. The study started on 2015-10-26. Estimated completion is 2018-02-16.
What interventions are being tested in trial NCT02415842?
The interventions under investigation include: Serum samples (OTHER).
Who is sponsoring clinical trial NCT02415842?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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