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Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758185
First Posted: January 1, 2013
Last Update Posted: March 28, 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):
Beijing Center for Disease Control and Prevention
  Purpose
The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

Condition Intervention Phase
Healthy Biological: recombinant hepatitis b vaccine Biological: Aleph influenza vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence rate of adverse events of the inactivated split influenza vaccine [ Time Frame: two years ]

Secondary Outcome Measures:
  • Antibody titre of the inactivated split influenza vaccine [ Time Frame: two years ]

Enrollment: 3308
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: recombinant hepatitis b vaccine
0.5ml intramuscular
Biological: recombinant hepatitis b vaccine
0.5ml intramuscular
Biological: Aleph influenza vaccine
0.5ml intramuscular
Experimental: Aleph influenza vaccine
0.5ml intramuscular
Biological: recombinant hepatitis b vaccine
0.5ml intramuscular
Biological: Aleph influenza vaccine
0.5ml intramuscular

Detailed Description:
A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • more than three years in good healthy

Exclusion Criteria:

  • current infectious fever or acute disease
  • upper respiratory infectious symptom within 6m
  • a history of allergy
  • laboratory confirmed influenza
  • autoimmune disease
  • have get influenza vaccine since 2008
  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): NCT01758185


Locations
China, Hebei
Xinglong County Center for Disease Control and Prevention
Zhangjiakou, Hebei, China
Zhuolu County Center for Disease Control and Prevention
Zhangjiakou, Hebei, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Principal Investigator: Nianmin Shi, Master Beijing Chaoyang District Center for Disease Control and Prevention
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01758185     History of Changes
Other Study ID Numbers: BJCDPC-3
First Submitted: December 20, 2012
First Posted: January 1, 2013
Last Update Posted: March 28, 2013
Last Verified: March 2013

Keywords provided by Beijing Center for Disease Control and Prevention:
Inactivated split influenza vaccine
Immunogenicity
Safety
Consistence

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