Hualanbio-influenza-IV-002

About this trial

Last updated 13 years ago

Study ID

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

3+ Years

All

Trial Timing

Ended 17 years ago

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.

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

Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine