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Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

NCT ID: NCT00556062

Last Updated: 2007-11-09

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

PHASE4

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-11-30

Brief Summary

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To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1: Lot 1

Group Type EXPERIMENTAL

seasonal split influenza vaccine

Intervention Type BIOLOGICAL

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

2: Lot 2

Group Type EXPERIMENTAL

seasonal split influenza vaccine

Intervention Type BIOLOGICAL

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

3: Lot 3

Group Type EXPERIMENTAL

seasonal split influenza vaccine

Intervention Type BIOLOGICAL

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

4: control vaccine

Group Type ACTIVE_COMPARATOR

seasonal split influenza vaccine

Intervention Type BIOLOGICAL

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Interventions

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seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Intervention Type BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Intervention Type BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Intervention Type BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 18-60 years old
* Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
* Not participate in any other clinical trials during the study
* Not receive any immunosuppressive agents during and one month prior to the study
* Be able to understand and sign the informed consent.

Exclusion Criteria

* Woman： Who breast-feeding or planning to become pregnant during the study
* Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
* Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Autoimmune disease or immunodeficiency
* Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
* Guillain-Barre Syndrome
* Women subjects with positive urinary pregnancy test
* Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
* Axillary temperature \>37.0 centigrade at the time of dosing
* Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

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Zhilun Zhang

Role: PRINCIPAL_INVESTIGATOR

Tianjin centers for Disease Control and Prevention

Other Identifiers

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PRO-INF-4005

Identifier Type: -

Identifier Source: org_study_id