Clinical trial NCT01568788: Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine
Official title: Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Influenza
Keywords: Respiratory Tract Infections; Orthomyxoviridae Infections
Lead sponsor: Hualan Biological Engineering, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of subjects with adverse reactions as a measure of safety study
timeFrame: 28 days after the vaccination
Secondary outcomes:
measure: Observation of the immunological effect
timeFrame: 28 days after the immunization
Other outcomes:
Locations:
city: Mianyang
country: China
facility: Yanting County
state: Sichuan
Study officials:
affiliation: Immune Planning Institute of Mianyang Center for Disease Prevention and Control
name: Pei-ru Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.