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| Sponsor: | Omninvest Vaccine Manufacturing, Researching and Trading Ltd. |
|---|---|
| Information provided by (Responsible Party): | Omninvest Vaccine Manufacturing, Researching and Trading Ltd. |
| ClinicalTrials.gov Identifier: | NCT01010893 |
Purpose
To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.
| Condition | Intervention |
|---|---|
|
Influenza |
Biological: Vaccination with Fluval P and Fluval AB influenza vaccines Biological: Vaccination with Fluval P monovalent influenza vaccine |
| 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 Monovalent Influenza Vaccine in Adults and Elderly Persons |
| Enrollment: | 355 |
| Study Start Date: | August 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Influenza vaccination
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose).
|
Biological: Vaccination with Fluval P monovalent influenza vaccine
Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant
Other Names:
|
|
Experimental: Influenza vaccination and co-vaccination
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
|
Biological: Vaccination with Fluval P and Fluval AB influenza vaccines
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
Other Names:
|
Primary Objective:
To assess tolerability/safety (incidence of adverse events) of the study drug. 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.
Secondary Objectives:
To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.
To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.
To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Hungary | |
| District Doctor's Office | |
| Pilisvorosvar, Hungary, H-2085 | |
| Fourmed Kft. Gyogyhaz | |
| Veszprem, Hungary, H-8200 | |
| Principal Investigator: | Ferenc Tamas, MD | Pilisvorosvar District Doctor's Office |
| Study Director: | Anna Osi, Dr. | Omninvest Ltd. |
More Information
| Responsible Party: | Omninvest Vaccine Manufacturing, Researching and Trading Ltd. |
| ClinicalTrials.gov Identifier: | NCT01010893 History of Changes |
| Other Study ID Numbers: | FLUVAL P-H-06 |
| Study First Received: | November 7, 2009 |
| Last Updated: | October 19, 2011 |
| Health Authority: | Hungary: National Institute of Pharmacy |
|
pandemic prevention influenza infection |
influenza vaccine vaccine influenza in humans |
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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 |