Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 15)

Beschrijving

Centre number

Datatype

integer

Alias

UMLS CUI [1,1]

C0600091 (Identifier)

SNOMED

118522005

LOINC

LP31795-5

UMLS CUI [1,2]

C0019994 (Hospitals)

Beschrijving

Subject number

Datatype

integer

Alias

UMLS CUI [1]

C2348585 (Clinical Trial Subject Unique Identifier)

Beschrijving

Print clearly in CAPITAL LETTERS using a black fountain or ball-point pen and press firmly so that all copies are legible. Insert the writing board beneath all copies of the form being completed. Fill in the Subject Number on every page and answer all questions except where otherwise indicated. Do not write in shaded areas which are qualified “For GSK”. Information written in these areas are not the responsibility of the investigator. ABBREVIATIONS: Abbreviations for medical conditions, clinical events or drug names should not be used. Units and route of administration of medication may be abbreviated. NA: not applicable. ERRORS/CORRECTIONS: Errors should be crossed out with a single line and the alteration made as near to the original as possible. All alterations must be printed, initialled and dated by the investigator or authorised staff. DATES Use the following three-letter abbreviations for each month: January = JAN February = FEB March = MAR April = APR May = MAY June = JUN July = JUL August = AUG September = SEP October = OCT November = NOV December = DEC Example: |__|__| |__|__|__| |__|__|__|__|= 1st January 2002 day month year The Serious Adverse Event (SAE) form must be checked for final assessment at the end of the study. For all subjects enrolled, please complete the Study Conclusion form. ADVERSE EVENT DEFINITIONS INTENSITY 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy). CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event. OUTCOME 1: Recovered / Resolved 2: Recovering / Resolving: If the subject is recovering at the time the subject completes the study or at the time the subject dropped out 3: Not recovered / Not resolved: This means an AE ongoing at the time the subject completes the study or becomes lost to follow-up; if AE/SAE was ongoing at the time of death, but was not the cause of death. 4: Recovered with sequelae / Resolved with sequelae SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: • results in death • is life threatening • results in persistent or significant disability / incapacity • requires in-patient hospitalization • prolongation of existing hospitalization • is a congenital anomaly / birth defect in the offspring of a study subject • In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event, please fill in the Serious Adverse Event (SAE) form and contact GlaxoSmithKline within 24 hours. Informed Consent has to be obtained prior to any study procedure.

Datatype

text

Alias

UMLS CUI [1]

C1508263 (General information section)

LOINC

MTHU015719

Beschrijving

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

Datatype

date

Alias

UMLS CUI [1]

C0021430 (Informed Consent)

Beschrijving

Centre number

Datatype

integer

Alias

UMLS CUI [1,1]

C0600091 (Identifier)

SNOMED

118522005

LOINC

LP31795-5

UMLS CUI [1,2]

C0019994 (Hospitals)

Beschrijving

Date of birth

Datatype

date

Alias

UMLS CUI [1]

C0421451 (Patient date of birth)

SNOMED

184099003

LOINC

LP57552-9

Beschrijving

Gender

Datatype

text

Alias

UMLS CUI [1]

C0079399 (Gender)

SNOMED

263495000

LOINC

LP61312-2

Beschrijving

Race

Datatype

text

Alias

UMLS CUI [1]

C0034510 (Racial group)

SNOMED

415229000

LOINC

LP7528-5

Beschrijving

anti-HAV and anti-HBs antibodies

Datatype

text

Alias

UMLS CUI [1]

C0201473 (Hepatitis A virus antibody measurement)

SNOMED

697001

UMLS CUI [2]

C0948254 (undefined)

Beschrijving

Please complete only if different from visit date

Datatype

date

Alias

UMLS CUI [1]

C1317250 (Collection Date)

Beschrijving

Hepatitis A or Hepatitis B vaccine

Datatype

text

Alias

UMLS CUI [1]

C0170300 (Hepatitis A Vaccines)

SNOMED

871751006

UMLS CUI [2]

C2240392 (Hepatitis B Vaccines)

SNOMED

871822003

Beschrijving

Hepatitis A or Hepatitis B vaccine: Specification

Datatype

text

Alias

UMLS CUI [1,1]

C0170300 (Hepatitis A Vaccines)

SNOMED

871751006

UMLS CUI [1,2]

C2348235 (Specification)

UMLS CUI [2,1]

C2240392 (Hepatitis B Vaccines)

SNOMED

871822003

UMLS CUI [2,2]

C2348235 (Specification)

Beschrijving

Hepatitis A or Hepatitis B immunoglobulins

Datatype

text

Alias

UMLS CUI [1]

C3652495 (hepatitis A immunoglobulin)

UMLS CUI [2]

C0062525 (hepatitis B immune globulin)

SNOMED

9542007

Beschrijving

Hepatitis A or Hepatitis B immunoglobulins: Specification

Datatype

text

Alias

UMLS CUI [1,1]

C3652495 (hepatitis A immunoglobulin)

UMLS CUI [1,2]

C2348235 (Specification)

UMLS CUI [2,1]

C0062525 (hepatitis B immune globulin)

SNOMED

9542007

UMLS CUI [2,2]

C2348235 (Specification)

Beschrijving

Hepatitis A or B infection

Datatype

boolean

Alias

UMLS CUI [1]

C0019159 (Hepatitis A)

SNOMED

40468003

UMLS CUI [2]

C0019163 (Hepatitis B)

SNOMED

66071002

LOINC

LA18126-5

Beschrijving

Hepatitis B Surface Antigens

Datatype

boolean

Alias

UMLS CUI [1]

C0019168 (Hepatitis B Surface Antigens)

SNOMED

22290004

LOINC

LP38331-2

Beschrijving

If YES to any of above, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ ADULT as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the study conclusion section only.

Datatype

boolean

Alias

UMLS CUI [1]

C0062524 (hepatitis A virus antibodies)

SNOMED

32609007

LOINC

LP38316-3