Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

March 27, 2013 updated by: Beijing Center for Disease Control and Prevention

Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3308

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of adverse events of the inactivated split influenza vaccine
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Antibody titre of the inactivated split influenza vaccine
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Nianmin Shi, Master, Beijing chaoyang district center for disease control and prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDPC-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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