CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Contraindications to Vaccination
text
Contraindications to Vaccination Anaphylactic Reaction
boolean
Contraindications to Vaccination Immunosuppressive or Immunodeficient condition
boolean
if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event.
text
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 low-grade febrile illness, i.e. Oral temperature < 37.5°C.
boolean
INFORMED CONSENT
Informed Consent
boolean
Informed Consent Date
date
Further Biological Samples Use
text
DEMOGRAPHICS
Center number:
integer
Birth Date
date
Gender
text
Ethnicity
text
Race
text
Specify Other
text
ELIGIBILITY CHECK
INCLUSION CRITERIA
Tick the boxes corresponding to any of the inclusion criteria the subject failed
boolean
Inclusion Criteria Age
boolean
Inclusion Criteria Written Consent
boolean
EXCLUSION CRITERIA
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Exclusion Criteria Previous Vaccination with Diphtheria/Tetanus Toxoids
boolean
Exclusion Criteria Unplanned Concomitant Medication
boolean
For corticosteroids, this will mean prednisone ³ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
boolean
Exclusion Criteria Planned Concomitant Vaccination
boolean
Exclusion Criteria Administration of Immunoglobulins
boolean
Exclusion Criteria Bacterial Pneumonia
boolean
Exclusion Criteria Invasive Pneumococcal Disease
boolean
Exclusion Criteria Thrombocytopenia / Bleeding Disorder.
boolean
Exclusion Criteria Immunosuppressive or Immunodeficient Condition
boolean
Exclusion Criteria Allergy
boolean
Exclusion Criteria Administration Product Containing MPL or QS21.
boolean
Exclusion Criteria Neurologic/ Mental disorders
boolean
Exclusion Criteria Inflammatory Processes
boolean
Exclusion Criteria Lymphoproliferative Disorders and Malignancies
boolean
(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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C.
boolean
Exclusion Criteria Acrocyanosis, Jaundice, Splenomegaly.
boolean
such as -Type 2 diabetes -Current or history of rheumatoid arthritis or temporal arthritis
boolean
-Serum haptoglobin > 180 mg/dL -Reticulocyte index (reticulocytosis): >2.5 for males and >4.1 for females -Other abnormalities Grade 2 or greater per the standard FDA Toxicity Grading Scale and the grades for study required blood tests not included within the FDA Toxicity Grading Scales or site specific grading scales pre-approved by GSK Biologicals, or elevated levels per discretion of the Investigator.
boolean
-Creatinine level <1.5 ULN -ALT levels <1.5 ULN -AST levels <1.5 ULN -Other serum abnormalities Grade 2 or greater per the standard FDA Toxicity Grading Scale and the grades for study required blood tests not included within the FDA Toxicity Grading Scales or site specific grading scales pre-approved by GSK Biologicals, or elevated levels per discretion of the Investigator.
boolean
Exclusion Criteria Alcohol / Drug Consumption
boolean
Exclusion Criteria Other Conditions
boolean
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Please report medication(s) as specified in the protocol and fill in the Medication section.
boolean
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
VITAL SIGNS
Heart Rate
integer
Blood Pressure Systolic
integer
Blood Pressure Diastolic
integer
Respiratory Rate
integer
HEMATOLOGY / BIOCHEMISTRY
HEMATOLOGY
Result below
float
Result below
integer
Result below
text
Result below
text
Result below
float
Result below
integer
Result below
text
Result below
text
Result below
text
Result below
text
BIOCHEMISTRY
BUN
float
Result below
float
AST/SGOT
float
ALT/SGPT
float
Cholesterol
float
Creatine phosphokinase
float
Serum Haptoglobin
float
Please complete the following informationwith LDH isoenzymes if the grade 2 or greater LDH is observed (> 1.5 ULN)
text
LDH
URINALYSIS
Urinalysis (Dipstick) Test
Result
integer
Proteins (via dipstick)
text
Glucose (via dipstick)
text
Ketones (via dipstick)
text
Blood and myoglobin (via dipstick)
text
Bilirubin (via dipstick)
text
Urobilinogen (via dipstick)
text
Nitrites (via dipstick)
text
Leukocyte esterase (via dipstick)
text
SCREENING CONCLUSION
only SAEs related to study participation or to a concurrent medication need to be considered and reported
boolean
total number of SAEs
integer
Was the subject withdrawn prior to randomisation or first vaccination?
boolean
Reason for failure
text
Specify Other
text
undefined item
integer
Who made the decision
text
INVESTIGATOR'S SIGNATURE
Investigator's Confirmation
date
Investigator's signature
text
Printed Investigator's name:
text