Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children

NCT01100294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-05-21

No results posted yet for this study

Summary

To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.

Conditions

Interventions

BIOLOGICAL

Vaccination with FLUVAL P

Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.

Sponsors & Collaborators

  • Fluart Innovative Vaccine Ltd, Hungary

    lead INDUSTRY

Principal Investigators

  • Anna Ősi, Dr. · Omninvest Ltd.

  • Éva Szabó, MD · "Csolnoky Ferenc" Veszprém County Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2010-05-31

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 NCT01100294 on ClinicalTrials.gov