Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

NCT ID: NCT01568788

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-03-31

Brief Summary

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.

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.

Conditions

Human Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Inactivated Influenza Vaccine

15μg HA/strain/0.5ml/syringe, Hualan Biologicals

Group Type: EXPERIMENTAL

Inactivated Influenza Vaccine

Intervention Type: BIOLOGICAL

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

Inactivated Influenza Vaccine of Pasteur

15ug HA/strain/0.5ml/syringe, Sanofi Pasteur

Group Type: ACTIVE_COMPARATOR

Inactivated Influenza Vaccine of Pasteur

Intervention Type: BIOLOGICAL

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,

Inactivated Influenza Vaccine of GSK

15ug HA/strain/0.5ml/syringe, GSK

Group Type: ACTIVE_COMPARATOR

Inactivated Influenza Vaccine of GSK

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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,

Intervention Type: 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

Intervention Type: BIOLOGICAL

Other Intervention Names

Hualan Biologicals; VAXIGRIP; Fluarix

Eligibility 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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hualan Biological Engineering, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-ru Zhang

Role: PRINCIPAL_INVESTIGATOR

Immune Planning Institute of Mianyang Center for Disease Prevention and Control

Locations

Yanting County

Mianyang, Sichuan, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 19954075 (View on PubMed)

Other Identifiers

Hualanbio-003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Hualanbio-influenza-IV-002

Identifier Type: -

Identifier Source: org_study_id