Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine
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.
|Human Influenza||Biological: Inactivated Influenza Vaccine Biological: Inactivated Influenza Vaccine of Pasteur Biological: Inactivated Influenza Vaccine of GSK|
|Study Design:||Allocation: Randomized
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|
- Number of subjects with adverse reactions as a measure of safety study [ Time Frame: 28 days after the vaccination ]Local reactions, systemic reactions, severity degree and AEFI correlation
- Observation of the immunological effect [ Time Frame: 28 days after the immunization ]HI antibody seroconversion ratios
|Study Start Date:||December 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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
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.
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568788
|Mianyang, Sichuan, China, 621000|
|Principal Investigator:||Pei-ru Zhang||Immune Planning Institute of Mianyang Center for Disease Prevention and Control|