Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01100294|
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : May 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Vaccination with FLUVAL P||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|"Csolnoky Ferenc" Veszprém County Hospital|
|Veszprém, Hungary, 8200|
|Study Director:||Anna Ősi, Dr.||Omninvest Ltd.|
|Principal Investigator:||Éva Szabó, MD||"Csolnoky Ferenc" Veszprém County Hospital|