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Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01758185
First received: December 20, 2012
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody titre of the inactivated split influenza vaccine [ Time Frame: two years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758185

Locations
China, Hebei
Zhuolu County Center for Disease Control and Prevention
Zhangjiakou, Hebei, China
Xinglong 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

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01758185     History of Changes
Other Study ID Numbers: BJCDPC-3
Study First Received: December 20, 2012
Last Updated: March 27, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013