Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)

Descrizione

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 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.

Tipo di dati

boolean

Descrizione

Date of visit

Tipo di dati

date

Descrizione

Subject number

Tipo di dati

integer

Descrizione

Informed consent

Tipo di dati

date

Descrizione

Center number

Tipo di dati

integer

Descrizione

Date of birth

Tipo di dati

date

Descrizione

Gender

Tipo di dati

text

Descrizione

Race

Tipo di dati

text

Descrizione

Specification of other race

Tipo di dati

text

Descrizione

Blood sample

Tipo di dati

text

Descrizione

Date of blood sample (if different from visit date)

Tipo di dati

date

Descrizione

Hepatitis A or Hepatitis B vaccine

Tipo di dati

text

Descrizione

Specification of received Hepatitis A or Hepatitis B vaccine

Tipo di dati

text

Descrizione

Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding

Tipo di dati

text

Descrizione

Specification of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding

Tipo di dati

text

Descrizione

Follow-up studies

Tipo di dati

text

Descrizione

Specification of the most appropriate reason the subject is not willing to participate in a follow-up study

Tipo di dati

text

Descrizione

Specification of Adverse Events or Serious Adverse Events

Tipo di dati

text

Descrizione

Specification of other reason for not willing to participate in a follow-up study

Tipo di dati

text

Descrizione

Occurence of Serious Adverse Event

Tipo di dati

text

Descrizione

Pregnancy information

Tipo di dati

text

Descrizione

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below

Tipo di dati

text

Descrizione

Date

Tipo di dati

date

Descrizione

Printed investigator´s name

Tipo di dati

text

Descrizione

Previous Subject Number

Tipo di dati

integer

Descrizione

Date of Birth

Tipo di dati

date

Descrizione

Reason for non participation

Tipo di dati

integer

Alias

UMLS CUI [1]

C3166257

Descrizione

Eligibility

Tipo di dati

text

Descrizione

Specification of adverse event or serious adverse event

Tipo di dati

text

Descrizione

Specification of other reason for non participation

Tipo di dati

text