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Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

NCT00556062 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2007-11-09

No results posted yet for this study

Summary

To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

Conditions

Interventions

BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

BIOLOGICAL

seasonal split influenza vaccine

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhilun Zhang · Tianjin centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Completion
2007-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556062 on ClinicalTrials.gov