- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407978
Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents
May 18, 2012 updated by: Fluart Innovative Vaccine Ltd, Hungary
Tolerability and Immunogenicity Study of FLUVAL P H1N1 Monovalent Influenza Vaccine of Omninvest in Children and Adolescents
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Veszprém, Hungary, 8200
- "Csolnoky Ferenc" Veszprém County Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vaccination with Fluval AB Novo
|
Other Names:
|
Active Comparator: Vaccination with Fluval AB
|
Other Names:
|
Experimental: Vaccination with Fluval P
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: 21-28 days after vaccination
|
21-28 days after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post vaccination HI antibody titer
Time Frame: 21-28 days after vaccination
|
21-28 days after vaccination
|
Incidence of adverse events
Time Frame: 180-210 days after vaccination
|
180-210 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Anna Ősi, Dr., Omninvest Ltd.
- Principal Investigator: Éva Szabó, MD, "Csolnoky Ferenc" Veszprém County Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 30, 2010
First Submitted That Met QC Criteria
August 1, 2011
First Posted (Estimate)
August 2, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2012
Last Update Submitted That Met QC Criteria
May 18, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLUVAL P-H-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza, Human
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
AVIR Green Hills Biotechnology AGCompletedSeasonal Human InfluenzaAustria
-
Emergent BioSolutionsCompleted
-
Novartis VaccinesCompleted
-
Novartis VaccinesCompleted
-
Novartis VaccinesCompleted
-
Hualan Biological Engineering, Inc.Completed
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Research Institute for Biological Safety ProblemsResearch Institute of Influenza, Russia; Asfendiyarov Kazakh National Medical...Completed
-
Novartis VaccinesCompleted
Clinical Trials on Vaccination with Fluval AB Novo
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompletedInfluenza ProphylaxisHungary
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
German Cancer Research CenterUniversity Hospital Heidelberg; National Center for Tumor Diseases, HeidelbergRecruiting
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Korea University Guro HospitalCompletedPneumococcal Infections | Influenza, HumanKorea, Republic of
-
Yonsei UniversityCompletedTuberculosis | BCG VaccinationKorea, Republic of