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

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ClinicalTrials.gov Identifier: NCT01100294
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Fluart Innovative Vaccine Ltd, Hungary

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Vaccination with FLUVAL P Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
Study Start Date : September 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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 vaccine
  • Influenza in humans
  • Vaccination of children



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 28 days after vaccination ]
    To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 180-210 days after vaccination ]
    To assess safety of the study drug after Day 180-210 following the vaccination.

  2. Efficacy of the study drug [ Time Frame: 180-210 days after vaccination ]
    To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.



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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100294


Locations
Hungary
"Csolnoky Ferenc" Veszprém County Hospital
Veszprém, Hungary, 8200
Sponsors and Collaborators
Fluart Innovative Vaccine Ltd, Hungary
Investigators
Study Director: Anna Ősi, Dr. Omninvest Ltd.
Principal Investigator: Éva Szabó, MD "Csolnoky Ferenc" Veszprém County Hospital

Responsible Party: Fluart Innovative Vaccine Ltd, Hungary
ClinicalTrials.gov Identifier: NCT01100294     History of Changes
Other Study ID Numbers: FLUVAL P-H-08
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by Fluart Innovative Vaccine Ltd, Hungary:
Influenza
Pandemic vaccine
Seasonal vaccine
Prevention
Influenza vaccine
Influenza in humans
Pandemic influenza in humans
Influenza vaccine for children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Aluminum phosphate
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents