Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Influenza split vaccine of 15 μg HA Biological: Influenza split vaccine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Single - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion) (0.5ml Formulation)

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Hualan Biological Engineering, Inc.:

Primary Outcome Measures:

Number of participants with adverse events as a measure of safety study [ Time Frame: 28 days after the vaccination ] [ Designated as safety issue: Yes ]
Include ADR, adverse event and severe adverse event.

Secondary Outcome Measures:

Observation of immunogenicity [ Time Frame: 28 days after the immunization ] [ Designated as safety issue: Yes ]
The rate of seroconversion, the rate of seroprotection, the GMT, and the antibody increasing folds of the subjects after administration with the vaccine.

Enrollment:	900
Study Start Date:	May 2006
Study Completion Date:	October 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Influenza split vaccine of 15μg HA 15μg HA/strain/0.5ml/vial	Biological: Influenza split vaccine of 15 μg HA 60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime Other Name: Hualan Bio Biological: Influenza split vaccine of 15 μg HA 558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime Other Name: Hualan Bio
Experimental: Influenza split vaccine of 15 μg HA 15μg HA/strain/0.5ml/syringe	Biological: Influenza split vaccine of 15 μg HA 60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime Other Name: Hualan Bio Biological: Influenza split vaccine of 15 μg HA 558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime Other Name: Hualan Bio
Active Comparator: Influenza split vaccine 15μg HA/strain/0.5ml/syringe	Biological: Influenza split vaccine 280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime Other Name: Shenzhen Aventis Pasteur

Detailed Description:

The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively.

Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Inclusion criteria for the primary vaccination on subjects over 3 years old and subjects 6 months～3 years old
- 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℃.
Inclusion criteria for the boost vaccination on subjects age 6 months～3 years
- Have no history of vaccination with other preventive product within the latest 1 week;
- Axillary temperature＜37.1℃.

Exclusion Criteria:

Exclusion criteria for the primary vaccination on subjects over 3 years old and subjects age 6 months～3 years
- 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.
Exclusion criteria for the boost vaccination on subjects age 6 months～3 years
- 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℃).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554813

Locations

China, Jiangsu
Jiangsu Provincial Center for Disease Prevention and Control
Nanjing, Jiangsu, China, 210000

Sponsors and Collaborators

Hualan Biological Engineering, Inc.

Investigators

Study Director:

Feng-cai Zhu, M.D.

Jiangsu Provicial Center for Disease Provention and Control

More Information

No publications provided

Responsible Party:	Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier:	NCT01554813 History of Changes
Other Study ID Numbers:	Hualanbio-influenza III-001, Hualanbio-phase III-001
Study First Received:	March 12, 2012
Last Updated:	September 4, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Hualan Biological Engineering, Inc.:

Influenza Vaccine, Vaccination,

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013