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Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01568788
First received: March 28, 2012
Last updated: June 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Human Influenza
Biological: Inactivated Influenza Vaccine
Biological: Inactivated Influenza Vaccine of Pasteur
Biological: Inactivated Influenza Vaccine of GSK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hualan Biological Engineering, Inc.:

Primary Outcome Measures:
  • Number of subjects with adverse reactions as a measure of safety study [ Time Frame: 28 days after the vaccination ] [ Designated as safety issue: Yes ]
    Local reactions, systemic reactions, severity degree and AEFI correlation


Secondary Outcome Measures:
  • Observation of the immunological effect [ Time Frame: 28 days after the immunization ] [ Designated as safety issue: Yes ]
    HI antibody seroconversion ratios


Enrollment: 600
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Fluarix

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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568788

Locations
China, Sichuan
Yanting County
Mianyang, Sichuan, China, 621000
Sponsors and Collaborators
Hualan Biological Engineering, Inc.
Investigators
Principal Investigator: Pei-ru Zhang Immune Planning Institute of Mianyang Center for Disease Prevention and Control
  More Information

Publications:
ZHANG Pei-ru; ZHU Xiao-ping; ZHOU Liang-jun; LIU You-quan; FAN Ya; CHEN Guo; CHEN Zhi; LIU Yan; SUN Hong-ying; WU Jian-lin. Safety and immunological effect of domestic split influenza vaccine. Chin J Prev Med, July 2009, Vol. 43, No. 7

Responsible Party: Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier: NCT01568788     History of Changes
Other Study ID Numbers: Hualanbio-influenza-IV-002, Hualanbio-003
Study First Received: March 28, 2012
Last Updated: June 18, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Hualan Biological Engineering, Inc.:
Respiratory Tract Infections; Orthomyxoviridae Infections

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014