Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial

Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008.

In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.

Study Overview

• Status: Completed
• Conditions: Human Influenza
• Intervention / Treatment: Biological: Inactivated Influenza Vaccine; Biological: Inactivated Influenza Vaccine of Pasteur; Biological: Inactivated Influenza Vaccine of GSK

Detailed Description

Dosage and administration route in this clinical trial:

Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime.

The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm.

The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements.

Safety indicators:

• Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ;
• Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ;
• Summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial.

Immunogenicity indicators:

Evaluate the Post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its HI antibody level on Day 28.

Take 1:10 serum dilution as the minimum dilutability. The seroconversion in this trial was defined as the post-vaccination HI antibody titer ≥ 1:40 when the HI antibody < 1:10 before the vaccination or the post-vaccination HI antibody titer quadruply increased when HI antibody ≥ 1:10 before the vaccination.

The Immunogenicity criteria set for this clinical trial is the seroconversion shall be > 40% after 14 days of the vaccination.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Mianyang, Sichuan, China, 621000
      • Yanting County

Participation Criteria

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:

• Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
• Healthy male or female 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 vaccination within the past 6 months and vaccination with other product within the latest 1 week;
• Axillary temperature <37.1℃.

Exclusion Criteria:

• Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy;
• Fever, acute disease or acute onset of chronic disease and influenza;
• Guillain-Barre Syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inactivated Influenza Vaccine; 15μg HA/strain/0.5ml/syringe, Hualan Biologicals	Biological: Inactivated Influenza Vaccine; 200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe, one dose regime; Other Names: Hualan Biologicals
Active Comparator: Inactivated Influenza Vaccine of Pasteur; 15ug HA/strain/0.5ml/syringe, Sanofi Pasteur	Biological: Inactivated Influenza Vaccine of Pasteur; 200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime,; Other Names: VAXIGRIP
Active Comparator: Inactivated Influenza Vaccine of GSK; 15ug HA/strain/0.5ml/syringe, GSK	Biological: Inactivated Influenza Vaccine of GSK; 200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe, one dose regime; Other Names: Fluarix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse reactions as a measure of safety study	Local reactions, systemic reactions, severity degree and AEFI correlation	28 days after the vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation of the immunological effect	HI antibody seroconversion ratios	28 days after the immunization

Collaborators and Investigators

• Sponsor: Hualan Biological Engineering, Inc.
• Investigators: Principal Investigator: Pei-ru Zhang, Immune Planning Institute of Mianyang Center for Disease Prevention and Control

Publications and helpful links

General Publications

• Zhang PR, Zhu XP, Zhou LJ, Liu YQ, Fan Y, Chen G, Chen Z, Liu Y, Sun HY, Wu JL. [Safety and immunological effect of domestic split influenza virus vaccine]. Zhonghua Yu Fang Yi Xue Za Zhi. 2009 Jul;43(7):615-8. Chinese.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): June 20, 2012
• Last Update Submitted That Met QC Criteria: June 18, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Respiratory Tract Infections; Orthomyxoviridae Infections
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Hualanbio-influenza-IV-002; Hualanbio-003 (Other Grant/Funding Number: Hualan Biological Engineering INC.)