MedTrace Logo

Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents

NCT01407978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2012-05-21

No results posted yet for this study

Summary

This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology testing.

Conditions

  • Novel 2009 Influenza H1N1
  • Influenza, Human

Interventions

BIOLOGICAL

Vaccination with Fluval P monovalent influenza vaccine

* 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/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.

BIOLOGICAL

Vaccination with Fluval AB

* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.

BIOLOGICAL

Vaccination with Fluval AB Novo

* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, 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
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Hungary

Study Locations

More Related Trials

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 NCT01407978 on ClinicalTrials.gov