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The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

NCT01336166 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-09-11

No results posted yet for this study

Summary

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.

Conditions

Interventions

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 45 μg

120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.

BIOLOGICAL

Placebo control

120 adults were assigned to receive 1 dose of placebo.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT01336166 on ClinicalTrials.gov