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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier:
NCT01100294
First received: March 30, 2010
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Influenza
Biological: Vaccination with FLUVAL P

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children

Resource links provided by NLM:


Further study details as provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:

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


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

  • Efficacy of the study drug [ Time Frame: 180-210 days after vaccination ] [ Designated as safety issue: No ]
    To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.


Enrollment: 10
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100294

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

No publications provided

Responsible Party: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier: NCT01100294     History of Changes
Other Study ID Numbers: FLUVAL P-H-08
Study First Received: March 30, 2010
Last Updated: May 18, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:
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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014