- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096238
Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months
April 11, 2010 updated by: National Taiwan University Hospital
In the spring of 2009, a recently emerged novel influenza A (H1N1) virus was first identified in Mexico and USA and it has continued to spread globally.
The rapid global spread of a novel influenza A (H1N1) 2009 virus prompted the World Health Organization (WHO), on 11 June 2009, to declare the first influenza pandemic in 41 years.
In Taiwan, a clinical study to assess the immunogenicity and safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in healthy volunteers has already been completed.
In the previous study, we found that a single 15 mcg HA dose of the AdimFlu-S (A/H1N1) vaccine induces a protective immune response in most adults, including those > 60 years of age (>70%).
Our current study aims to follow-up subjects who received Influenza Virus Vaccine, AdimFlu-S (A/H1N1), six months ago.
These subjects' serum samples were tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).
The seroconversion is defined as the post-vaccination serum HAI titer had at least 1:40 for subjects who had seronegative pre-vaccination or a four-fold or greater increase in HAI titers for subjects who had seropositive pre-vaccination serum.
The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after half a year will be analyzed and discussed among the subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
185
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
age>=18 who had AdimFlu-S(A/H1N1) injection
Description
Inclusion Criteria:
- subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kuo-Chin Huang, Post Doctor, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Study Registration Dates
First Submitted
March 29, 2010
First Submitted That Met QC Criteria
March 30, 2010
First Posted (Estimate)
March 31, 2010
Study Record Updates
Last Update Posted (Estimate)
April 13, 2010
Last Update Submitted That Met QC Criteria
April 11, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201002050R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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