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Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People

NCT01408290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2012-05-21

No results posted yet for this study

Summary

The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Conditions

Interventions

BIOLOGICAL

Vaccination with FAB-3511

One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

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 FAB-9011

One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA 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

  • József Fűzi, MD · Family Doctor's Office, Dunakeszi

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

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

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01408290 on ClinicalTrials.gov