Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01096238
First received: March 29, 2010
Last updated: April 11, 2010
Last verified: April 2010
  Purpose

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.


Condition
Influenza

Study Type: Observational
Official Title: Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 185
Study Start Date: March 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

age>=18 who had AdimFlu-S(A/H1N1) injection

Criteria

Inclusion Criteria:

  • subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096238

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Kuo-Chin Huang, Post Doctor National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Huang, Kuo Chin, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01096238     History of Changes
Other Study ID Numbers: 201002050R
Study First Received: March 29, 2010
Last Updated: April 11, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after half a year will be analyzed and discussed.

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014