Human Influenza Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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