Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Human Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568788
• Other study ID #: Hualanbio-influenza-IV-002
• Secondary ID: Hualanbio-003
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: June 18, 2012
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2012
• Source: Hualan Biological Engineering, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Human Influenza
• Influenza, Human

Intervention

Biological:
• Inactivated Influenza Vaccine
200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe, one dose regime
• Inactivated Influenza Vaccine of Pasteur
200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime,
• Inactivated Influenza Vaccine of GSK
200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe, one dose regime

Locations

Country	Name	City	State
China	Yanting County	Mianyang	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Hualan Biological Engineering, Inc.

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse reactions as a measure of safety study	Local reactions, systemic reactions, severity degree and AEFI correlation	28 days after the vaccination	Yes
Secondary	Observation of the immunological effect	HI antibody seroconversion ratios	28 days after the immunization	Yes