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Comparison of the Cellular and the Humoral Immunogenicity, Safety of Different Trivalent Influenza Vaccines

NCT01119157 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2010-05-07

No results posted yet for this study

Summary

This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged \> 18 and \< 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

influenza vaccine

whole virus influenza vaccine adjuvanted with aluminium phosphate, 3 x 15 μg HA / 0.5 ml, for i.m. administration subunit influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration split influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration

Sponsors & Collaborators

  • Netherlands Vaccine Institute

    collaborator UNKNOWN

  • National Public Health Institute, Finland

    collaborator UNKNOWN

  • National Centre for Epidemiology, Hungary

    lead OTHER_GOV

Principal Investigators

  • Ildikó Visontai, MD · National Centre for Epidemiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-03-31
Completion
2010-08-31

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Drugs

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 NCT01119157 on ClinicalTrials.gov