|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01459276 |
|
Date of registration:
|
19/10/2011 |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects
|
|
Scientific title:
|
A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6µgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects |
|
Date of first enrolment:
|
October 2011 |
|
Target sample size:
|
1206 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01459276 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Hungary
| | | | | | | |
|
Contacts
|
|
Name:
|
Péter Vajer, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Biatorbágy |
|
|
Name:
|
Judit Simon, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Budapest |
|
|
Name:
|
Péter Torzsa, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Budapest |
|
|
Name:
|
Barna Boze, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Hatvan |
|
|
Name:
|
Ferenc Tamás, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Pilisvörösvár |
|
|
Name:
|
Ágnes Hasitz, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Szentendre |
|
|
Name:
|
Tibor Hrutka, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Family Doctor's Office, Vecsés |
|
|
Name:
|
Gabor Kollar, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Omninvest Ltd |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- male and female adult volunteers aged 18 years or older,
- mentally competent,
- able to understand and comply with all study requirements,
- willing and able to give written informed consent prior to initiation of study
procedures,
- in good health (as determined by clinical judgement of the investigator on the basis
of medical history 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.
- Female subjects aged 18 to 60 years (i.e. participants of childbearing potential)
with a negative result from the urine pregnancy test prior to vaccination who agrees
to use an acceptable contraception method or abstinence throughout the trial and not
become pregnant for the duration of the study.
- Absence of existence of any exclusion criteria.
Exclusion Criteria:
- Pregnancy, breast-feeding or positive urine pregnancy test at baseline prior to
vaccination. Female subjects who are able to bear children but not willing to use an
acceptable contraception method for the duration of the study.
- Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin,
ciprofloxacin, neomycin or any other component of the vaccine;
- History of anaphylactic shock or neurological symptoms or signs following
administration of any vaccine;
- History of Guillain-Barré syndrome;
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic
disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute
or progressive renal disease, congestive heart failure;
- Immunosuppressive therapy within the past 36 months;
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Receipt of immunostimulants;
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within
the past 3 months;
- Suspected or known HIV, HBV or HCV infection;
- Acute disease and/or axillary temperature =37oC within the past 3 days;
- Vaccine therapy within the past 4 weeks;
- Influenza vaccination (any kind) within the past 6 months;
- Experimental drug therapy within the past 4 weeks;
- Concomitant participation in another clinical study;
- Any condition which, in the opinion of the investigator, may interfere with the
evaluation of the study;
- Past or current psychiatric disease of the subject that upon judgement of the
investigator may have effect on the objective decision-making of the subject;
- Alcohol or drug abuse of the subject.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Influenza
|
|
Intervention(s)
|
|
Biological: Vaccination with FAB-6011
|
|
Biological: Vaccination with FluvalAB
|
|
Primary Outcome(s)
|
|
Measures of immunogenicity
[Time Frame: 21-28 days following vaccination]
|
|
Measures of safety
[Time Frame: 21-28 days following vaccination]
|
|
Secondary Outcome(s)
|
|
Measures of long term immunogenicity
[Time Frame: 110-120 days following vaccination]
|
|
Measures of long term safety
[Time Frame: 110-120 days following vaccination]
|
|
Secondary ID(s)
|
|
2011-003314-16
|
|
FluvalAB-H-15
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|