Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Condition(s) targeted: Human Influenza

Intervention: Inactivated Influenza Vaccine (Biological); Inactivated Influenza Vaccine of Pasteur (Biological); Inactivated Influenza Vaccine of GSK (Biological)

Phase: N/A

Status: Completed

Sponsored by: Hualan Biological Engineering, Inc.

Official(s) and/or principal investigator(s):
Pei-ru Zhang, Principal Investigator, Affiliation: Immune Planning Institute of Mianyang Center for Disease Prevention and Control

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.

Official title: Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of subjects with adverse reactions as a measure of safety study

Secondary outcome: Observation of the immunological effect

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.

Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.

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

Yanting County, Mianyang, Sichuan 621000, China

Starting date: December 2008
Last updated: June 18, 2012