Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Beijing Center for Disease Control and Prevention3,308 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

3,308

Conditions

Healthy

Interventions

recombinant hepatitis b vaccineBIOLOGICAL

0.5ml intramuscular

Aleph influenza vaccineBIOLOGICAL

0.5ml intramuscular

Eligibility

Sex: ALLMin age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Xinglong County Center for Disease Control and Prevention

Zhangjiakou, Hebei, China

Zhuolu County Center for Disease Control and Prevention

Zhangjiakou, Hebei, China

Outcomes

Primary Outcomes

Incidence rate of adverse events of the inactivated split influenza vaccine

Time frame: two years

Secondary Outcomes

Antibody titre of the inactivated split influenza vaccine

Time frame: two years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.