Immune Response Study of Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wu Jiang, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier:
NCT01310374
First received: March 7, 2011
Last updated: July 9, 2013
Last verified: July 2013
  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 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Wu Jiang, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier: NCT01310374     History of Changes
Other Study ID Numbers: BJCDCWJ201101
Study First Received: March 7, 2011
Last Updated: July 9, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypersensitivity, Delayed
Influenza, Human
Hypersensitivity
Immune System Diseases
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014