ID

35591

Description

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

Keywords

  1. 3/11/19 3/11/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 11, 2019

DOI

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License

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

Administrative data
Description

Administrative data

Visit
Description

Visit

Data type

text

Date of visit
Description

Date of visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

ELIMINATION CRITERIA
Description

ELIMINATION CRITERIA

The following criteria should be checked at each visit subsequent to the first visit.
Description

If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis.

Data type

text

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Description

Concomitant Medication

Data type

boolean

Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
Description

For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.

Data type

boolean

Administration of immunoglobulins and/or any blood products during the study.
Description

mmunoglobulins

Data type

boolean

Administration of any vaccine other than the study vaccine during the study.
Description

Concomitant Vaccination

Data type

boolean

INFORMED CONSENT
Description

INFORMED CONSENT

I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent

Data type

boolean

Informed Consent Date:
Description

Informed Consent Date

Data type

date

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?
Description

Further use of biological samples

Data type

text

DEMOGRAPHICS
Description

DEMOGRAPHICS

Center number:
Description

Center number

Data type

integer

Date of Birth:
Description

Date of Birth

Data type

date

Gender:
Description

Gender

Data type

text

Ethnicity:
Description

Ethnicity

Data type

text

Race:
Description

Race

Data type

text

Specify Other
Description

Specify Other

Data type

text

Height:
Description

Height

Data type

integer

Measurement units
  • cm
cm
Weight:
Description

Weight

Data type

float

Measurement units
  • kg
kg
ELIGIBILITY CHECK
Description

ELIGIBILITY CHECK

Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.

Data type

boolean

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.
Description

Eligibility Check Reminder

Data type

text

INCLUSION CRITERIA
Description

INCLUSION CRITERIA

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.
Description

Tick "No" corresponding to any of the inclusion criteria the subject failed.

Data type

boolean

A male or female aged 18 years or above at the time of the vaccination.
Description

Tick "No" corresponding to any of the inclusion criteria the subject failed.

Data type

boolean

Written informed consent obtained from the subject.
Description

Tick "No" corresponding to any of the inclusion criteria the subject failed.

Data type

boolean

Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
Description

Tick "No" corresponding to any of the inclusion criteria the subject failed.

Data type

boolean

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.
Description

Tick "No" corresponding to any of the inclusion criteria the subject failed.

Data type

boolean

EXCLUSION CRITERIA
Description

EXCLUSION CRITERIA

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.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Description

For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.

Data type

boolean

Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Administration of an influenza vaccine within 1 year preceding the study start.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Administration of an influenza vaccine other than the study vaccine during the entire study
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Clinically or virologically confirmed influenza infection within 1 year preceding the study start
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Acute disease at the time of enrolment.
Description

Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without lowgrade febrile illness, i.e. Axillary temperature <37.5°C

Data type

boolean

Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Not stabilized or clinically serious chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insuline-dependent diabetes mellitus)
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Lactating female
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

History of chronic alcohol consumption and/or drug abuse.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Description

Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

boolean

TREATMENT ALLOCATION
Description

TREATMENT ALLOCATION

Record treatment number:
Description

treatment number

Data type

integer

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Description

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Skin and subcutaneous tissue
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Musculoskeletal and connective tissue
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Cardiac System
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Vascular System
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Respiratory, thoracic and mediastinal
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Gastrointestinal System
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Hepatobiliary System
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Renal and urinary system
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Nervous System
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Eye
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Ear and labyrinth
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Endocrine
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Metabolism and nutrition
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Blood and lymphatic system
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Immune system (incl allergies, autoimmune disorders)
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Infections and infestations
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Neoplasms benign, malignant and unspecified (incl cysts, polyps)
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Surgical and medical procedures
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Other
Description

DIAGNOSIS

Data type

text

Status
Description

Please report medication(s) as specified in the protocol and fill in the Medication section.

Data type

text

HISTORY OF INFLUENZA VACCINATION
Description

HISTORY OF INFLUENZA VACCINATION

Has the subject been vaccinated against influenza within the last three seasons?
Description

If Yes, please specify

Data type

boolean

Specify
Description

tick all that apply

Data type

integer

LABORATORY TESTS
Description

LABORATORY TESTS

Has a blood sample been taken for antibody determination (7.5 mL)?
Description

ANTIBODY DETERMINATION (HI)

Data type

boolean

Date
Description

Date

Data type

date

HCG URINE PREGNANCY TEST
Description

HCG URINE PREGNANCY TEST

Has a urine sample been taken?
Description

HCG URINE PREGNANCY TEST

Data type

text

Date
Description

Date

Data type

date

Result:
Description

Pregnancy Test Result

Data type

text

VACCINE ADMINISTRATION
Description

VACCINE ADMINISTRATION

Date
Description

Date

Data type

date

Pre-Vaccination temperature:
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
°C
Route:
Description

Route

Data type

text

Vaccine
Description

Vaccine

Data type

text

Side
Description

According Protocol Non-dominant arm

Data type

text

Site
Description

According Protocol Deltoid

Data type

text

Route
Description

According Protocol I.M.

Data type

text

Comment
Description

Comment

Data type

text

VACCINE NON-ADMINISTRATION
Description

VACCINE NON-ADMINISTRATION

Why not administered?
Description

Please tick the major reason for non administration.

Data type

text

In case of SAE, please specify SAE No.
Description

Please complete and submit SAE report

Data type

integer

In case AE, please specify AE No.
Description

AE No.

Data type

integer

Specify Other
Description

e.g.: consent withdrawal, Protocol violation, …

Data type

text

Please tick who made the decision:
Description

Who made decision

Data type

text

IMMEDIATE POST-VACCINATION OBSERVATION
Description

IMMEDIATE POST-VACCINATION OBSERVATION

Data type

text

SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS
Description

SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If any of these adverse events meets the protocol definition of serious, please complete and submit a Serious Adverse Event report to GSK Biologicals Study Contact for SAE reporting within 24 hours.

Data type

text

Local Symptoms - Redness
Description

Local Symptoms - Redness

Day
Description

Day

Data type

text

Redness
Description

Redness

Data type

boolean

Size
Description

Redness Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Local Symptoms - Swelling
Description

Local Symptoms - Swelling

Day
Description

Day

Data type

integer

Swelling
Description

Swelling

Data type

boolean

If Yes, record the size
Description

If Yes, record the size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medically attended visit
Description

Medically attended visit

Data type

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Data type

text

Local Symptoms - Induration
Description

Local Symptoms - Induration

Day
Description

Day

Data type

text

Induration
Description

Induration

Data type

boolean

Size
Description

Induration Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Local Symptoms - Ecchymosis
Description

Local Symptoms - Ecchymosis

Day
Description

Day

Data type

integer

Ecchymosis
Description

Ecchymosis

Data type

boolean

Size
Description

Ecchymosis Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Local Symptoms - Pain
Description

Local Symptoms - Pain

Day
Description

Day

Data type

text

Pain
Description

Pain

Data type

boolean

Intensity
Description

Pain Intensity

Data type

integer

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
Description

SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS

Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Solicited Adverse Events Question

Data type

text

General Symptoms - Temperature
Description

General Symptoms - Temperature

Day
Description

Day

Data type

text

Temperature
Description

Temperature

Data type

boolean

Description

Data type

float

Measurement units
  • °C
°C
Route
Description

Route

Data type

text

Not taken (temperature)
Description

Temperature not taken

Data type

boolean

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

General Symptoms - Fatigue
Description

General Symptoms - Fatigue

Day
Description

Day

Data type

integer

Fatigue
Description

Fatigue

Data type

boolean

Intensity
Description

Fatigue Intensity

Data type

text

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

boolean

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

General Symptoms - Headache
Description

General Symptoms - Headache

Day
Description

Day

Data type

integer

Headache
Description

Headache

Data type

boolean

Intensity
Description

Headache Intensity

Data type

integer

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

General Symptoms - Myalgia
Description

General Symptoms - Myalgia

Day
Description

Day

Data type

text

Myalgia
Description

Myalgia

Data type

boolean

Intensity
Description

Myalgia Intensity

Data type

text

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

General Symptoms - Shivering
Description

General Symptoms - Shivering

Day
Description

Day

Data type

integer

Shivering
Description

Shivering

Data type

boolean

Intensity
Description

Shivering Intensity

Data type

integer

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

General Symptoms - Arthralgia
Description

General Symptoms - Arthralgia

Day
Description

Day

Data type

text

Arthralgia
Description

Arthralgia

Data type

boolean

Intensity
Description

Arthralgia Intensity

Data type

text

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

General Symptoms - Sweating increase
Description

General Symptoms - Sweating increase

Day
Description

Day

Data type

text

Sweating increase
Description

Sweating increase

Data type

boolean

Intensity
Description

Sweating increase Intensity

Data type

integer

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last Day of Symptoms
Description

Date

Data type

date

Causality?
Description

Causality

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

UNSOLICITED ADVERSE EVENTS
Description

UNSOLICITED ADVERSE EVENTS

Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
Description

Unsolicited Adverse Event

Data type

text

Similar models

Visit "Day 0" Vaccination

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Visit
Item
Visit
text
Date of visit
Item
Date of visit
date
Subject Number
Item
Subject Number
integer
Item Group
ELIMINATION CRITERIA
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
Item Group
INFORMED CONSENT
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)
Item Group
DEMOGRAPHICS
Center number
Item
Center number:
integer
Date of Birth
Item
Date of Birth:
date
Item
Gender:
text
Code List
Gender:
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnicity:
text
Code List
Ethnicity:
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race:
text
Code List
Race:
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
Item Group
ELIGIBILITY CHECK
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
Item Group
INCLUSION CRITERIA
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
Item Group
EXCLUSION CRITERIA
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
Item Group
TREATMENT ALLOCATION
treatment number
Item
Record treatment number:
integer
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal and connective tissue
Item
Musculoskeletal and connective tissue
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Cardiac
Item
Cardiac System
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Vascular
Item
Vascular System
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal System
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Hepatobiliary
Item
Hepatobiliary System
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Renal and urinary
Item
Renal and urinary system
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Nervous system
Item
Nervous System
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Eye
Item
Eye
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Ear and labyrinth
Item
Ear and labyrinth
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Metabolism and nutrition
Item
Metabolism and nutrition
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Blood and lymphatic system
Item
Blood and lymphatic system
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Immune system
Item
Immune system (incl allergies, autoimmune disorders)
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Infections and infestations
Item
Infections and infestations
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Neoplasms
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Surgical and medical procedures
Item
Surgical and medical procedures
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Other
Item
Other
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
HISTORY OF INFLUENZA VACCINATION
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)
Item Group
LABORATORY TESTS
ANTIBODY DETERMINATION (HI)
Item
Has a blood sample been taken for antibody determination (7.5 mL)?
boolean
Date
Item
Date
date
Item Group
HCG URINE PREGNANCY TEST
Item
Has a urine sample been taken?
text
Code List
Has a urine sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (Not of childbearing potential or male) (3)
Date
Item
Date
date
Item
Result:
text
Code List
Result:
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
VACCINE ADMINISTRATION
Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
Item
Route:
text
Code List
Route:
CL Item
Axillary (preferable) (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Item
Vaccine
text
Code List
Vaccine
CL Item
Study Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Not administered (Please complete following section) (3)
Item
Side
text
Code List
Side
CL Item
Dominant (1)
CL Item
Non dominant (2)
Item
Site
text
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
VACCINE NON-ADMINISTRATION
Item
Why not administered?
text
Code List
Why not administered?
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
Item
Please tick who made the decision:
text
Code List
Please tick who made the decision:
CL Item
Investigator (1)
CL Item
Subject (2)
Item
IMMEDIATE POST-VACCINATION OBSERVATION
text
Code List
IMMEDIATE POST-VACCINATION OBSERVATION
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 Group
SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS
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)
Item Group
Local Symptoms - Redness
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Local Symptoms - Swelling
Item
Day
integer
Code List
Day
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
Item
If Yes, record the visit type
text
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Induration
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Local Symptoms - Ecchymosis
Item
Day
integer
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Local Symptoms - Pain
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Pain
Item
Pain
boolean
Item
Intensity
integer
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
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)
Item Group
General Symptoms - Temperature
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Temperature
Item
Temperature
boolean
Item
float
Item
Route
text
Code List
Route
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Fatigue
Item
Day
integer
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Fatigue
Item
Fatigue
boolean
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Headache
Item
Day
integer
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Headache
Item
Headache
boolean
Item
Intensity
integer
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Myalgia
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Myalgia
Item
Myalgia
boolean
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Shivering
Item
Day
integer
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Shivering
Item
Shivering
boolean
Item
Intensity
integer
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Arthralgia
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Arthralgia
Item
Arthralgia
boolean
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Sweating increase
Item
Day
text
Code List
Day
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
Item
Intensity
integer
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
UNSOLICITED ADVERSE EVENTS
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.)

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