Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Phase 4

Completed

• Conditions: Healthy
• Interventions: Biological: recombinant hepatitis b vaccine; Biological: Aleph influenza vaccine

• Registration Number: NCT01758185
• Lead Sponsor: Beijing Center for Disease Control and Prevention

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-11
• Study Completion: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-31
• Study First Posted: 2013-01-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant hepatitis b vaccine	Aleph influenza vaccine	0.5ml intramuscular
Aleph influenza vaccine	recombinant hepatitis b vaccine	0.5ml intramuscular
recombinant hepatitis b vaccine	recombinant hepatitis b vaccine	0.5ml intramuscular
Aleph influenza vaccine	Aleph influenza vaccine	0.5ml intramuscular

Primary Outcome Measures

Name	Time	Method
Incidence rate of adverse events of the inactivated split influenza vaccine	two years

Secondary Outcome Measures

Name	Time	Method
Antibody titre of the inactivated split influenza vaccine	two years

Trial Locations

Locations (2)

Xinglong County Center for Disease Control and Prevention; 🇨🇳 Zhangjiakou, Hebei, China

Zhuolu County Center for Disease Control and Prevention; 🇨🇳 Zhangjiakou, Hebei, China