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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Vaccination with FLUVAL P

Detailed Description

This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.

Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Veszprém, Hungary, 8200
    • "Csolnoky Ferenc" Veszprém County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 6 to 36 months, both sexes;
• Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
• Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;
• Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;
• Absence of existence of any exclusion criteria.

Exclusion Criteria:

• Known allergy to eggs or other components of the vaccine (in particular mercury);
• History of Guillain-Barré syndrome;
• Active neoplasm;
• Former or on-going immunosuppressive therapy;
• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
• Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
• Documented HIV, HBV or HCV infection;
• Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study;
• Acute febrile respiratory illness within one week prior to vaccination;
• Vaccine therapy within 4 weeks prior to vaccination;
• Influenza vaccination within 6 months prior to vaccination;
• Experimental drug therapy within 1 month prior to vaccination;
• Past or current psychiatric disease of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative;
• Alcohol or drug abuse of the legitimate representative.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Influenza; Pandemic vaccine; Prevention; Influenza in humans; Influenza vaccine; Vaccination of children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.	28 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	To assess safety of the study drug after Day 180-210 following the vaccination.	180-210 days after vaccination
Efficacy of the study drug	To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.	180-210 days after vaccination

Collaborators and Investigators

• Sponsor: Fluart Innovative Vaccine Ltd, Hungary
• Investigators: Study Director: Anna Ősi, Dr., Omninvest Ltd.; Principal Investigator: Éva Szabó, MD, "Csolnoky Ferenc" Veszprém County Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: May 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Influenza; Prevention; Influenza vaccine; Pandemic vaccine; Seasonal vaccine; Influenza in humans; Pandemic influenza in humans; Influenza vaccine for children
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FLUVAL P-H-08