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

NCT ID: NCT01100294

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-05-31

Brief Summary

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

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaccination with FLUVAL P

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Influenza; Pandemic vaccine; Prevention; Influenza vaccine; Influenza in humans; Vaccination of children

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fluart Innovative Vaccine Ltd, Hungary

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Ősi, Dr.

Role: STUDY_DIRECTOR

Omninvest Ltd.

Éva Szabó, MD

Role: PRINCIPAL_INVESTIGATOR

"Csolnoky Ferenc" Veszprém County Hospital

Locations

"Csolnoky Ferenc" Veszprém County Hospital

Veszprém, Veszprém megye, Hungary

Countries

Hungary

Other Identifiers

FLUVAL P-H-08

Identifier Type: -

Identifier Source: org_study_id