Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine

NCT01511744 | Completed Phase 4 DMC

• 2 other identifiers: Hualanbio-influenza IV-001Hualanbio-phase IV-001
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the influenza immunity of age 3 and older population. Phase III clinical study was conducted in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008. In order to monitor and evaluate the safety and protective effect against influenza administered on age 3 and older population, therefore we conduct the phase IV clinical trial of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).

Conditions

Human Influenza

Keywords

Respiratory Tract Infections; Orthomyxoviridae Infections

Outcome Measures

Primary Outcomes (1)

• Safety study

  Include ADR, adverse event, and severe adverse event.

  28days

Secondary Outcomes (1)

• Observation of immune protective effect

  1year

Study Arms (2)

Inactivated influenza split vaccine

EXPERIMENTAL

Biological: Experimental: influenza split vaccine of 15 μg HA, one dose regime

Biological: Inactivated influenza split vaccine

Blank control

NO INTERVENTION

Interventions

Inactivated influenza split vaccine BIOLOGICAL

3000 participants (750 of above 60,750 of age 19-60, 750 of age 13-18 and 750 of age 3-12) to receive influenza split vaccine of 15 μg HA; one dose regime

Also known as: Hualan Bio

Inactivated influenza split vaccine

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 aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
• Be able to abide by the requirement of clinical trial protocol to participate in follow up;
• Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
• 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 and vaccination with other product in latest 1 week;
• Axillary temperature ≤37℃.

You may not qualify if:

• Any history of severe illness, such as tumor, autoimmune disease, etc.;
• Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
• History of neurological symptom or physical signs;
• Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
• Bleeding physique or prolonged bleeding;
• History of influenza infection or vaccination at least once within the past 6 months;
• History of administration of other vaccine or injection of immunoglobulin, or any research drug within the past 1 week;
• Any acute disease that needs usage of antibiotics or antiviral therapy on the whole body within the past 7 days;
• Fever (axillary temperature≥38℃) within the past 3 days;
• Participating in another clinical trial;
• History of Guillain-Barre Syndrome, severe birth defect or severe disease, allergy, eclampsia, epilepsy, encephalopathy or psychosis or family disease;
• Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection;
• Known or suspected other diseases at the same time, including respiratory system disease, acute infection or active period of chronic disease, HIV infection of infant or mother, cardiovascular disease, during of treatment of cancer and skin disease;
• Any condition that, in the judgment of investigator, may affect trial assessment.

Sponsors & Collaborators

• Hualan Biological Engineering, Inc.: lead

Study Sites (1)

Henan Province Center for Disease Preventionand Control

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Xu Bianli, Master

  Henan Province Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 19, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 14, 2012

Record last verified: 2012-03

Locations

CN (1)