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Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)

NCT ID: NCT01554813

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Influenza

Keywords

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Influenza Vaccine, Vaccination,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Influenza split vaccine of 15μg HA

15μg HA/strain/0.5ml/vial

Group Type EXPERIMENTAL

Influenza split vaccine of 15 μg HA

Intervention Type BIOLOGICAL

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

Influenza split vaccine of 15 μg HA

Intervention Type BIOLOGICAL

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

Influenza split vaccine of 15 μg HA

15μg HA/strain/0.5ml/syringe

Group Type EXPERIMENTAL

Influenza split vaccine of 15 μg HA

Intervention Type BIOLOGICAL

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

Influenza split vaccine of 15 μg HA

Intervention Type BIOLOGICAL

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

Influenza split vaccine

15μg HA/strain/0.5ml/syringe

Group Type ACTIVE_COMPARATOR

Influenza split vaccine

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Influenza split vaccine of 15 μg HA

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

Intervention Type BIOLOGICAL

Influenza split vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Hualan Bio Hualan Bio Shenzhen Aventis Pasteur

Eligibility Criteria

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Inclusion Criteria

* 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℃.

Exclusion Criteria

* 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.

* 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℃).
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hualan Biological Engineering, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feng-cai Zhu, M.D.

Role: STUDY_DIRECTOR

Jiangsu Provicial Center for Disease Provention and Control

Locations

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Jiangsu Provincial Center for Disease Prevention and Control

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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Hualanbio-phase III-001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Hualanbio-influenza III-001

Identifier Type: -

Identifier Source: org_study_id