Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Beijing Center for Disease Prevention and Control

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Biological: Aleph influenza vaccine; Biological: recombinant hepatitis b vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01758185

BJCDPC-3

Details and patient eligibility

About

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

Full description

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.

Enrollment: 3,308 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,308 participants in 2 patient groups, including a placebo group

recombinant hepatitis b vaccine

Placebo Comparator group

Description:

0.5ml intramuscular

Treatment:

Biological: Aleph influenza vaccine

Biological: recombinant hepatitis b vaccine

Aleph influenza vaccine

Experimental group

Description:

0.5ml intramuscular

Treatment:

Biological: Aleph influenza vaccine

Biological: recombinant hepatitis b vaccine