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Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

NCT01010893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2012-05-21

No results posted yet for this study

Summary

To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.

Conditions

Interventions

BIOLOGICAL

Vaccination with Fluval P and Fluval AB influenza vaccines

Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).

BIOLOGICAL

Vaccination with Fluval P monovalent influenza vaccine

Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant

Sponsors & Collaborators

  • Fluart Innovative Vaccine Ltd, Hungary

    lead INDUSTRY

Principal Investigators

  • Ferenc Tamas, MD · Pilisvorosvar District Doctor's Office

  • Anna Osi, Dr. · Omninvest Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-09-30
Completion
2010-02-28

Countries

  • Hungary

Study Locations

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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 NCT01010893 on ClinicalTrials.gov