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A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects

NCT01459276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1206

Last updated 2012-05-21

No results posted yet for this study

Summary

The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Conditions

Interventions

BIOLOGICAL

Vaccination with FAB-6011

One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

BIOLOGICAL

Vaccination with FluvalAB

One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Sponsors & Collaborators

  • Fluart Innovative Vaccine Ltd, Hungary

    lead INDUSTRY

Principal Investigators

  • Gabor Kollar, MD · Omninvest Ltd

  • Ferenc Tamás, MD · Family Doctor's Office, Pilisvörösvár

  • Ágnes Hasitz, MD · Family Doctor's Office, Szentendre

  • Judit Simon, MD · Family Doctor's Office, Budapest

  • Barna Bőze, MD · Family Doctor's Office, Hatvan

  • Tibor Hrutka, MD · Family Doctor's Office, Vecsés

  • Péter Torzsa, MD · Family Doctor's Office, Budapest

  • Péter Vajer, MD · Family Doctor's Office, Biatorbágy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2012-03-31

Countries

  • Hungary

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 NCT01459276 on ClinicalTrials.gov