Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine
Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the influenza immunity of age 3 and older population. Phase III clinical study was conducted in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.
In order to monitor and evaluate the safety and protective effect against influenza administered on age 3 and older population, therefore we conduct the phase IV clinical trial of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).
|Human Influenza||Biological: Inactivated influenza split vaccine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)|
- Safety study [ Time Frame: 28days ]Include ADR, adverse event, and severe adverse event.
- Observation of immune protective effect [ Time Frame: 1year ]Observe immunogenicity and immune protective effect by means of active and passive monitoring. Period is one year.
|Study Start Date:||November 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Inactivated influenza split vaccine
Biological: Experimental: influenza split vaccine of 15 μg HA, one dose regime
Biological: Inactivated influenza split vaccine
3000 participants (750 of above 60,750 of age 19-60, 750 of age 13-18 and 750 of age 3-12) to receive influenza split vaccine of 15 μg HA; one dose regime
Other Name: Hualan Bio
|No Intervention: Blank control|
Select three sites to conduct this study in Henan, china. In the principle of informed consent and voluntary participation, adopt randomized and control design and include 6000 healthy subjects, among them, trial group 3000 persons, blank control group 3000 persons respectively and randomized dividing into 4 age groups.
The evaluation of safety: For all the vaccinated subjects, monitor general reaction and post-vaccination AEFI by mean of active soliciting and passive report. The evaluation of safety data mainly includes summary of clinical reaction endpoint, local and systemic adverse events of all subjects during the observation period and incidence rate of relevant ADR/AE.
The evaluation of immunogenicity: Respectively and randomly sample 600 persons from vaccination group and blank control group. Collect venous blood on the first day or 28 day of vaccination. Adopt international universal HI testing method(SRID) to carry out serology test.
The criteria for HI antibody test result:
- Take 1:10 serum as the lowest dilutability. For subjects whose HI antibody <1:10 before immunization, calculate as 1:5 and their post-vaccination HI antibody titer≥1:40 will be as the seroconversion. For subjects HI antibody ≥1:10 before the vaccination, take post-vaccination HI antibody titer increases 4 times as seroconversion;
- Take HI antibody titer≥1:40 as threshold of positive protection;
- Take statistics of subject number whose serum HI antibody titer reach protective level (HI antibody titer≥1:40). Calculate protection rate of vaccine and 95% CI;
- GMT titer and 95% CI. Evaluation of immune protective effect: Monitor Influenza Like Illness(ILI) to all subjects in monitoring place and conduct epidemiological survey to ILI. Collect nasopharyngeal swab and blood specimen during acute and recovery period for the laboratory test.
ILI refers to fever (body temperature≥38℃) with cough or pharyngalgia. Test influenza virus nucleic acid in nasopharyngeal swab. Isolate serum of blood specimen and carry out the test of serum antibody.
- Statistics of ILI incidence rate in immune population
- Statistics of incidence rate in monitoring place
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511744
|Henan Province Center for Disease Preventionand Control|
|Zhengzhou, Henan, China|
|Principal Investigator:||Xu Bianli, Master||Henan Province Center for Disease Prevention and Control|