Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)

NCT01554813 | Completed Phase 3 DMC

• 2 other identifiers: Hualanbio-influenza III-001Hualanbio-phase III-001
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population.

Conditions

Influenza

Keywords

Influenza Vaccine, Vaccination,

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of safety study

  Include ADR, adverse event and severe adverse event.

  28 days after the vaccination

Secondary Outcomes (1)

• Observation of immunogenicity

  28 days after the immunization

Study Arms (3)

Influenza split vaccine of 15μg HA

EXPERIMENTAL

15μg HA/strain/0.5ml/vial

Biological: Influenza split vaccine of 15 μg HA

Influenza split vaccine of 15 μg HA

EXPERIMENTAL

15μg HA/strain/0.5ml/syringe

Biological: Influenza split vaccine of 15 μg HA

Influenza split vaccine

ACTIVE COMPARATOR

15μg HA/strain/0.5ml/syringe

Biological: Influenza split vaccine

Interventions

Influenza split vaccine of 15 μg HA BIOLOGICAL

60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime

Also known as: Hualan Bio

Influenza split vaccine of 15 μg HA; Influenza split vaccine of 15μg HA

Influenza split vaccine BIOLOGICAL

280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime

Also known as: Shenzhen Aventis Pasteur

Influenza split vaccine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female 6 months or over, subject (or their guardians) are able to understand and sign informed consent
• Healthy person 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 influenza vaccination within the past 6 months and vaccination with other product within the latest 1 week;
• Axillary temperature\<37.1℃.
• Have no history of vaccination with other preventive product within the latest 1 week;
• Axillary temperature\<37.1℃.

You may not qualify if:

• Serious diseases, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, COPD needing oxygen uptake treatment, acute or progressive liver or kidney disease, CHF, etc.
• Subjects who are allergic to any component of test vaccine (history of vaccination allergy), especially allergic to eggs
• History of symptoms or signs in neurological system
• Known or suspected (high risk of onset) damaged or abnormal immunologic function need receiving immunosuppressant or immunopotentiator treatment; history of receiving immunoglobulin or blood product or plasma extractive outside the gastrointestinal tract within the past 3 months; and HIV infection or relevant diseases
• Haemorrhage physique or extension of haemorrhage time
• History of influenza or at least once influenza vaccination within the past 6 months
• History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
• History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
• History of fever within the past three days (axillary temperature≥37.1℃)
• Participating in another clinical trial
• History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
• Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
• Serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, and GBS)
• Known or suspected diseases at the same time, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of infants or mothers, CVD, serious hypertension, during the treatment of tumor and skin disease
• Any condition may affect trial assessment in judgment of investigators.

Sponsors & Collaborators

• Hualan Biological Engineering, Inc.: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Prevention and Control

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Feng-cai Zhu, M.D.

  Jiangsu Provicial Center for Disease Provention and Control

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 15, 2012
• Study Start: May 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: October 1, 2006
• Last Updated: September 6, 2012

Record last verified: 2012-03

Locations

CN (1)