Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

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

3308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

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Detailed Description

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A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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recombinant hepatitis b vaccine

0.5ml intramuscular

Group Type PLACEBO_COMPARATOR

recombinant hepatitis b vaccine

Intervention Type BIOLOGICAL

0.5ml intramuscular

Aleph influenza vaccine

Intervention Type BIOLOGICAL

0.5ml intramuscular

Aleph influenza vaccine

0.5ml intramuscular

Group Type EXPERIMENTAL

recombinant hepatitis b vaccine

Intervention Type BIOLOGICAL

0.5ml intramuscular

Aleph influenza vaccine

Intervention Type BIOLOGICAL

0.5ml intramuscular

Interventions

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recombinant hepatitis b vaccine

0.5ml intramuscular

Intervention Type BIOLOGICAL

Aleph influenza vaccine

0.5ml intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* more than three years in good healthy

Exclusion Criteria

* current infectious fever or acute disease
* upper respiratory infectious symptom within 6m
* a history of allergy
* laboratory confirmed influenza
* autoimmune disease
* have get influenza vaccine since 2008

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes