Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT01201902
Brief Summary:
The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.
Detailed Description:
▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay
1. Proportion of subjects, stratified by group, with seroconversion to HI antibody
2. Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus
3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer
* Safety Outcome Measures :
1\. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 21 \~ 6 months)
Study:
NCT01201902
Study Brief:
Protocol Section:
NCT01201902