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Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT01758185
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Biological: recombinant hepatitis b vaccine Biological: Aleph influenza vaccine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3308 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

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

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 Posted: January 1, 2013    Key Record Dates
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