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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier:
NCT01407978
First received: March 30, 2010
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Novel 2009 Influenza H1N1
Influenza, Human
Biological: Vaccination with Fluval P monovalent influenza vaccine
Biological: Vaccination with Fluval AB
Biological: Vaccination with Fluval AB Novo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Tolerability and Immunogenicity Study of FLUVAL P H1N1 Monovalent Influenza Vaccine of Omninvest in Children and Adolescents

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: 21-28 days after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post vaccination HI antibody titer [ Time Frame: 21-28 days after vaccination ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 180-210 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Other Names:
  • Fluval AB Novo
  • FL-K-13/09
Active Comparator: 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
  • 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.
Other Names:
  • Fluval AB
  • 5609
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/ 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 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.
Other Names:
  • Fluval P
  • FL-P-K-01/09

Detailed Description:

Primary Objective:

  • To assess tolerability/safety (incidence of adverse events 21-28 days following vaccination) of the study drug.

Secondary Objectives:

  • To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21‑28 after immunization in groups and age groups.
  • To assess long term (180-210 days following vaccination) tolerability/safety (incidence of adverse events) of the study drug.
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged 3 to 12 years, adolescents aged 12 to 18 years, 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)m such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study.
  • Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method (includes implants, injectibles, combined oral contraceptives, effective intrauterine devices /IUDs/, sexual abstinence, or a vasectomized partner) or abstinence throughout the trial and not become pregnant for the duration of the study.
  • Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;
  • Absence of existence of any exclusion criteria.

Exclusion Criteria:

  • Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
  • Known allergy to eggs or other components of the vaccine (in particular mercury);
  • History of Guillain-Barré syndrome;
  • Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
  • Immunosuppressive therapy in the preceding 36 months;
  • Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids (local corticosteroid or corticosteroid nasal spray are permitted);
  • 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 interfere with the evaluation of the immunoresponse;
  • 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 volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer or the legitimate representative;
  • Alcohol or drug abuse of the participant or 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: NCT01407978

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: NCT01407978     History of Changes
Other Study ID Numbers: FLUVAL P-H-07
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
Influenza vaccine for adolescents
Seasonal vaccine for children
Seasonal vaccine for adolescents

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

ClinicalTrials.gov processed this record on July 22, 2014