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35591
Beschrijving
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza
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Versies (1)
- 11-03-19 11-03-19 -
Houder van rechten
GSK group of companies
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11 maart 2019
DOI
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Creative Commons BY-NC 3.0
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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631
Visit "Day 0" Vaccination
- StudyEvent: ODM
Similar models
Visit "Day 0" Vaccination
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Visit
Item
Visit
text
Date of visit
Item
Date of visit
date
Subject Number
Item
Subject Number
integer
Check Elimination Criteria
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
Concomitant Medication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
boolean
immunosuppressants or immunemodifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
boolean
mmunoglobulins
Item
Administration of immunoglobulins and/or any blood products during the study.
boolean
Concomitant Vaccination
Item
Administration of any vaccine other than the study vaccine during the study.
boolean
Informed Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
Informed Consent Date
Item
Informed Consent Date:
date
Item
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the Fluarix TM vaccine or the influenza disease under study?
text
Code List
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the Fluarix TM vaccine or the influenza disease under study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Center number
Item
Center number:
integer
Date of Birth
Item
Date of Birth:
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other (10)
Specify Other
Item
Specify Other
text
Height
Item
Height:
integer
Weight
Item
Weight:
float
Entry Criteria Met
Item
Did the subject meet all the entry criteria?
boolean
Eligibility Check Reminder
Item
Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.
text
Subject Reliability
Item
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
Age of subject
Item
A male or female aged 18 years or above at the time of the vaccination.
boolean
Informed Consent Obtained
Item
Written informed consent obtained from the subject.
boolean
Healthy Subjects
Item
Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
boolean
Female of Non-Childbearing Potential
Item
If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
boolean
Concomitant Medication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
boolean
Chronic Administration of Immunosuppressants
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
boolean
Administration of Immunoglobulins
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
boolean
Previous Administration of an Influenza Vaccine
Item
Administration of an influenza vaccine within 1 year preceding the study start.
boolean
Concomitant Administration of an Influenza Vaccine
Item
Administration of an influenza vaccine other than the study vaccine during the entire study
boolean
Previous Influenza Infection
Item
Clinically or virologically confirmed influenza infection within 1 year preceding the study start
boolean
Allergies
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
Acute Ongoing Disease
Item
Acute disease at the time of enrolment.
boolean
pulmonary, cardiovascular, hepatic or renal functional abnormality
Item
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
chronic underlying disease
Item
Not stabilized or clinically serious chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insuline-dependent diabetes mellitus)
boolean
Lactating female.
Item
Lactating female
boolean
chronic alcohol or drug consumption
Item
History of chronic alcohol consumption and/or drug abuse.
boolean
Confirmed or Suspected Immunodeficient Condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
Medical conditions affecting study procedure
Item
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
boolean
treatment number
Item
Record treatment number:
integer
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue
text
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal and connective tissue
Item
Musculoskeletal and connective tissue
text
CL Item
Past (1)
CL Item
Current (2)
Cardiac
Item
Cardiac System
text
CL Item
Past (1)
CL Item
Current (2)
Vascular
Item
Vascular System
text
CL Item
Past (1)
CL Item
Current (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal
text
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal System
text
CL Item
Past (1)
CL Item
Current (2)
Hepatobiliary
Item
Hepatobiliary System
text
CL Item
Past (1)
CL Item
Current (2)
Renal and urinary
Item
Renal and urinary system
text
CL Item
Past (1)
CL Item
Current (2)
Nervous system
Item
Nervous System
text
CL Item
Past (1)
CL Item
Current (2)
Eye
Item
Eye
text
CL Item
Past (1)
CL Item
Current (2)
Ear and labyrinth
Item
Ear and labyrinth
text
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine
text
CL Item
Past (1)
CL Item
Current (2)
Metabolism and nutrition
Item
Metabolism and nutrition
text
CL Item
Past (1)
CL Item
Current (2)
Blood and lymphatic system
Item
Blood and lymphatic system
text
CL Item
Past (1)
CL Item
Current (2)
Immune system
Item
Immune system (incl allergies, autoimmune disorders)
text
CL Item
Past (1)
CL Item
Current (2)
Infections and infestations
Item
Infections and infestations
text
CL Item
Past (1)
CL Item
Current (2)
Neoplasms
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
text
CL Item
Past (1)
CL Item
Current (2)
Surgical and medical procedures
Item
Surgical and medical procedures
text
CL Item
Past (1)
CL Item
Current (2)
Other
Item
Other
text
CL Item
Past (1)
CL Item
Current (2)
Previous Influenza Vaccination
Item
Has the subject been vaccinated against influenza within the last three seasons?
boolean
CL Item
Season 2007 – 2008 (1)
CL Item
Season 2006 – 2007 (2)
CL Item
Season 2005 – 2006 (3)
ANTIBODY DETERMINATION (HI)
Item
Has a blood sample been taken for antibody determination (7.5 mL)?
boolean
Date
Item
Date
date
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (Not of childbearing potential or male) (3)
Date
Item
Date
date
CL Item
Negative (1)
CL Item
Positive (2)
Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
CL Item
Axillary (preferable) (1)
CL Item
Oral (2)
CL Item
Rectal (3)
CL Item
Study Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Not administered (Please complete following section) (3)
CL Item
Dominant (1)
CL Item
Non dominant (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
SAE No.
Item
In case of SAE, please specify SAE No.
integer
AE No.
Item
In case AE, please specify AE No.
integer
Specify Other
Item
Specify Other
text
CL Item
Investigator (1)
CL Item
Subject (2)
CL Item
If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the (1)
CL Item
Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event (Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event)
CL Item
report (report)
CL Item
If any prophylactic medication has been administered in anticipation of study vaccine reaction, please (2)
CL Item
complete the Medication section and tick prophylactic box (complete the Medication section and tick prophylactic box)
CL Item
Any other vaccines administered during the study period must be recorded in the Concomitant (3)
CL Item
Vaccination section (Vaccination section)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness
Item
Redness
boolean
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Induration
Item
Induration
boolean
Induration Size
Item
Size
integer
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Ecchymosis
Item
Ecchymosis
boolean
Ecchymosis Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Pain
Item
Pain
boolean
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (4)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Temperature
Item
Temperature
boolean
t°
Item
t°
float
CL Item
Axillary (preferable) (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Temperature not taken
Item
Not taken (temperature)
boolean
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Fatigue
Item
Fatigue
boolean
CL Item
normal (1)
CL Item
that is easily tolerated (2)
CL Item
that interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
boolean
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Headache
Item
Headache
boolean
CL Item
normal (1)
CL Item
that is easily tolerated (2)
CL Item
that interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Myalgia
Item
Myalgia
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Shivering
Item
Shivering
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Arthralgia
Item
Arthralgia
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Sweating increase
Item
Sweating increase
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes -> Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as (4)
CL Item
necessary. (necessary.)