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Immune Response Study of Influenza Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310374
First Posted: March 8, 2011
Last Update Posted: July 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wu Jiang, Centers for Disease Control and Prevention, China
  Purpose
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.

Condition
Influenza Vaccine Allergy Cell Mediated Reaction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humoral and Cellular Immune Response Study of Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Wu Jiang, Centers for Disease Control and Prevention, China:

Primary Outcome Measures:
  • the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
blood

Enrollment: 207
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time.

The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • aged 12-60 years old
  • male or non-pregnant female
  • volunteers
  • clinically healthy as determined by: medical history inquiring and physical examination
  • provide written informed consents before joining the trial

Exclusion Criteria:

  • infected with Influenza A virus subtype H1N1(2009),
  • vaccinated with seasonal influenza vaccine,
  • allergic to any ingredient of vaccine,
  • autoimmune disease or immunodeficiency,
  • active malignancy,
  • bleeding disorder,
  • seizure disorder,
  • Guillain-Barre Syndrome,
  • treatment with cytotoxic or immunosuppressive drugs within the past 6 months,
  • receipt of blood products within the past 3 months,
  • administration of any other investigational research agents or live attenuated vaccine within 30 days,
  • administration of subunit or inactivated vaccines within 14 days,
  • axillary temperature over 37.0℃ at the time of vaccination.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310374


Sponsors and Collaborators
Centers for Disease Control and Prevention, China
Investigators
Principal Investigator: jiang wu, Bachelor Beijing Centers for Disease Control and Prevention
  More Information

Responsible Party: Wu Jiang, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier: NCT01310374     History of Changes
Other Study ID Numbers: BJCDCWJ201101
First Submitted: March 7, 2011
First Posted: March 8, 2011
Last Update Posted: July 10, 2013
Last Verified: July 2013

Keywords provided by Wu Jiang, Centers for Disease Control and Prevention, China:
influenza vaccine
immune response
dynamic changes

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs