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Completed

NCT Number: NCT01758185

Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

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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Key information

Conditions

Healthy

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant hepatitis B vaccine

Biological

0.5ml intramuscular

Aleph influenza vaccine

Biological

0.5ml intramuscular

Primary outcomes

  1. Incidence rate of adverse events of the inactivated split influenza vaccine

    Time frame: two years

Secondary outcomes

  1. Antibody titre of the inactivated split influenza vaccine

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Beijing Center for Disease Control and Prevention

Other Gov

Registry information

Official study title

Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 1, 2013
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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