Back to resultsPhase IV Clinical Trial of an Inactivated Influenza Split Vaccine
Primary Purpose
Human Influenza
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inactivated influenza split vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Human Influenza focused on measuring Respiratory Tract Infections; Orthomyxoviridae Infections
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
- Be able to abide by the requirement of clinical trial protocol to participate in follow up;
- Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
- 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 and vaccination with other product in latest 1 week;
- Axillary temperature ≤37℃.
Exclusion Criteria:
- Any history of severe illness, such as tumor, autoimmune disease, etc.;
- Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
- History of neurological symptom or physical signs;
- Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
- Bleeding physique or prolonged bleeding;
- History of influenza infection or vaccination at least once within the past 6 months;
History of administration of other vaccine or injection of immunoglobulin, or any research drug within the past 1 week;
- Any acute disease that needs usage of antibiotics or antiviral therapy on the whole body within the past 7 days;
- Fever (axillary temperature≥38℃) within the past 3 days;
- Participating in another clinical trial;
- History of Guillain-Barre Syndrome, severe birth defect or severe disease, allergy, eclampsia, epilepsy, encephalopathy or psychosis or family disease;
- Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection;
- Known or suspected other diseases at the same time, including respiratory system disease, acute infection or active period of chronic disease, HIV infection of infant or mother, cardiovascular disease, during of treatment of cancer and skin disease;
- Any condition that, in the judgment of investigator, may affect trial assessment.
Sites / Locations
- Henan Province Center for Disease Preventionand Control
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Inactivated influenza split vaccine
Blank control
Arm Description
Biological: Experimental: influenza split vaccine of 15 μg HA, one dose regime
Outcomes
Primary Outcome Measures
Safety study
Include ADR, adverse event, and severe adverse event.
Secondary Outcome Measures
Observation of immune protective effect
Observe immunogenicity and immune protective effect by means of active and passive monitoring. Period is one year.
Full Information
NCT ID
NCT01511744
First Posted
January 18, 2012
Last Updated
August 13, 2012
Sponsor
Hualan Biological Engineering, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01511744
Brief Title
Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine
Official Title
A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hualan Biological Engineering, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
Evaluation indicator:
Statistics of ILI incidence rate in immune population
Statistics of incidence rate in monitoring place
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Influenza
Keywords
Respiratory Tract Infections; Orthomyxoviridae Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inactivated influenza split vaccine
Arm Type
Experimental
Arm Description
Biological: Experimental: influenza split vaccine of 15 μg HA, one dose regime
Arm Title
Blank control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza split vaccine
Other Intervention Name(s)
Hualan Bio
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety study
Description
Include ADR, adverse event, and severe adverse event.
Time Frame
28days
Secondary Outcome Measure Information:
Title
Observation of immune protective effect
Description
Observe immunogenicity and immune protective effect by means of active and passive monitoring. Period is one year.
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
Be able to abide by the requirement of clinical trial protocol to participate in follow up;
Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
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 and vaccination with other product in latest 1 week;
Axillary temperature ≤37℃.
Exclusion Criteria:
Any history of severe illness, such as tumor, autoimmune disease, etc.;
Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
History of neurological symptom or physical signs;
Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
Bleeding physique or prolonged bleeding;
History of influenza infection or vaccination at least once within the past 6 months;
History of administration of other vaccine or injection of immunoglobulin, or any research drug within the past 1 week;
Any acute disease that needs usage of antibiotics or antiviral therapy on the whole body within the past 7 days;
Fever (axillary temperature≥38℃) within the past 3 days;
Participating in another clinical trial;
History of Guillain-Barre Syndrome, severe birth defect or severe disease, allergy, eclampsia, epilepsy, encephalopathy or psychosis or family disease;
Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection;
Known or suspected other diseases at the same time, including respiratory system disease, acute infection or active period of chronic disease, HIV infection of infant or mother, cardiovascular disease, during of treatment of cancer and skin disease;
Any condition that, in the judgment of investigator, may affect trial assessment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Bianli, Master
Organizational Affiliation
Henan Province Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Province Center for Disease Preventionand Control
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Learn more about this trial
Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine
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