Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)

September 4, 2012 updated by: Hualan Biological Engineering, Inc.

A Single - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion) (0.5ml Formulation)

The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively.

Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial Center for Disease Prevention and Control

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

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Inclusion criteria for the primary vaccination on subjects over 3 years old and subjects 6 months～3 years old

    • Healthy male and female 6 months or over, subject (or their guardians) are able to understand and sign informed consent
    • Healthy person by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
    • Be able to comply with the requirement of clinical trial protocol
    • Have no history of influenza vaccination within the past 6 months and vaccination with other product within the latest 1 week;
    • Axillary temperature<37.1℃.

  2. Inclusion criteria for the boost vaccination on subjects age 6 months～3 years

    • Have no history of vaccination with other preventive product within the latest 1 week;
    • Axillary temperature<37.1℃.

Exclusion Criteria:

  1. Exclusion criteria for the primary vaccination on subjects over 3 years old and subjects age 6 months～3 years

    • Serious diseases, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, COPD needing oxygen uptake treatment, acute or progressive liver or kidney disease, CHF, etc.
    • Subjects who are allergic to any component of test vaccine (history of vaccination allergy), especially allergic to eggs
    • History of symptoms or signs in neurological system
    • Known or suspected (high risk of onset) damaged or abnormal immunologic function need receiving immunosuppressant or immunopotentiator treatment; history of receiving immunoglobulin or blood product or plasma extractive outside the gastrointestinal tract within the past 3 months; and HIV infection or relevant diseases
    • Haemorrhage physique or extension of haemorrhage time
    • History of influenza or at least once influenza vaccination within the past 6 months
    • History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
    • History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
    • History of fever within the past three days (axillary temperature≥37.1℃)
    • Participating in another clinical trial
    • History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
    • Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
    • Serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, and GBS)
    • Known or suspected diseases at the same time, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of infants or mothers, CVD, serious hypertension, during the treatment of tumor and skin disease
    • Any condition may affect trial assessment in judgment of investigators.

  2. Exclusion criteria for the boost vaccination on subjects age 6 months～3 years

    • History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
    • History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
    • History of fever within the past three days (axillary temperature≥37.1℃).

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Influenza split vaccine of 15μg HA
15μg HA/strain/0.5ml/vial
Biological: Influenza split vaccine of 15 μg HA
60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime
Other Names:
  • Hualan Bio
Biological: Influenza split vaccine of 15 μg HA
558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
Other Names:
  • Hualan Bio
Experimental: Influenza split vaccine of 15 μg HA
15μg HA/strain/0.5ml/syringe
Biological: Influenza split vaccine of 15 μg HA
60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime
Other Names:
  • Hualan Bio
Biological: Influenza split vaccine of 15 μg HA
558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
Other Names:
  • Hualan Bio
Active Comparator: Influenza split vaccine
15μg HA/strain/0.5ml/syringe
Biological: Influenza split vaccine
280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
Other Names:
  • Shenzhen Aventis Pasteur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as a measure of safety study
Time Frame: 28 days after the vaccination
Include ADR, adverse event and severe adverse event.
28 days after the vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observation of immunogenicity
Time Frame: 28 days after the immunization
The rate of seroconversion, the rate of seroprotection, the GMT, and the antibody increasing folds of the subjects after administration with the vaccine.
28 days after the immunization

Collaborators and Investigators

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

Sponsor

Hualan Biological Engineering, Inc.

Investigators

  • Study Director: Feng-cai Zhu, M.D., Jiangsu Provicial Center for Disease Provention and Control

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

May 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hualanbio-influenza III-001
  • Hualanbio-phase III-001 (Other Grant/Funding Number: Hualan Biological Engineering Inc.)

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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