Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

NCT01568788 | Completed DMC

• 2 other identifiers: Hualanbio-influenza-IV-002Hualanbio-003
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Influenza

Keywords

Respiratory Tract Infections; Orthomyxoviridae Infections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Observation of the immunological effect

  28 days after the immunization

Study Arms (3)

Inactivated Influenza Vaccine

EXPERIMENTAL

15μg HA/strain/0.5ml/syringe, Hualan Biologicals

Biological: Inactivated Influenza Vaccine

Inactivated Influenza Vaccine of Pasteur

ACTIVE COMPARATOR

15ug HA/strain/0.5ml/syringe, Sanofi Pasteur

Biological: Inactivated Influenza Vaccine of Pasteur

Inactivated Influenza Vaccine of GSK

ACTIVE COMPARATOR

15ug HA/strain/0.5ml/syringe, GSK

Biological: Inactivated Influenza Vaccine of GSK

Interventions

Inactivated Influenza Vaccine BIOLOGICAL

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

Also known as: Hualan Biologicals

Inactivated Influenza Vaccine

Inactivated Influenza Vaccine of Pasteur BIOLOGICAL

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,

Also known as: VAXIGRIP

Inactivated Influenza Vaccine of Pasteur

Inactivated Influenza Vaccine of GSK BIOLOGICAL

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

Also known as: Fluarix

Inactivated Influenza Vaccine of GSK

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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℃.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hualan Biological Engineering, Inc.: lead

Study Sites (1)

Yanting County

Mianyang, Sichuan, 621000, China

Location

Related 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.

  PMID: 19954075 RESULT

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections; Orthomyxoviridae Infections

Interventions

vaxigrip; fluarix

Condition Hierarchy (Ancestors)

Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Pei-ru Zhang

  Immune Planning Institute of Mianyang Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 2, 2012
• Study Start: December 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 20, 2012

Record last verified: 2012-04

Locations

CN (1)