ID
35502
Description
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal
Keywords
Versions (1)
- 3/6/19 3/6/19 -
Copyright Holder
GSK group of companies
Uploaded on
March 6, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Screening Visit
- StudyEvent: ODM
Description
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Description
Contraindications to Vaccination
Data type
text
Description
Contraindications to Vaccination Anaphylactic Reaction
Data type
boolean
Description
Contraindications to Vaccination Immunosuppressive or Immunodeficient condition
Data type
boolean
Description
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for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator.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.
Data type
text
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 low-grade febrile illness, i.e. Oral temperature < 37.5°C.
Data type
boolean
Description
INFORMED CONSENT
Description
Informed Consent
Data type
boolean
Description
Informed Consent Date
Data type
date
Description
Further Biological Samples Use
Data type
text
Description
DEMOGRAPHICS
Description
Center number:
Data type
integer
Description
Birth Date
Data type
date
Description
Gender
Data type
text
Description
Ethnicity
Data type
text
Description
Race
Data type
text
Description
Specify Other
Data type
text
Description
ELIGIBILITY CHECK
Description
INCLUSION CRITERIA
Description
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Data type
boolean
Description
Inclusion Criteria Age
Data type
boolean
Description
Inclusion Criteria Written Consent
Data type
boolean
Description
EXCLUSION CRITERIA
Description
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Exclusion Criteria Previous Vaccination with Diphtheria/Tetanus Toxoids
Data type
boolean
Description
Exclusion Criteria Unplanned Concomitant Medication
Data type
boolean
Description
For corticosteroids, this will mean prednisone ³ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Data type
boolean
Description
Exclusion Criteria Planned Concomitant Vaccination
Data type
boolean
Description
Exclusion Criteria Administration of Immunoglobulins
Data type
boolean
Description
Exclusion Criteria Bacterial Pneumonia
Data type
boolean
Description
Exclusion Criteria Invasive Pneumococcal Disease
Data type
boolean
Description
Exclusion Criteria Thrombocytopenia / Bleeding Disorder.
Data type
boolean
Description
Exclusion Criteria Immunosuppressive or Immunodeficient Condition
Data type
boolean
Description
Exclusion Criteria Allergy
Data type
boolean
Description
Exclusion Criteria Administration Product Containing MPL or QS21.
Data type
boolean
Description
Exclusion Criteria Neurologic/ Mental disorders
Data type
boolean
Description
Exclusion Criteria Inflammatory Processes
Data type
boolean
Description
Exclusion Criteria Lymphoproliferative Disorders and Malignancies
Data type
boolean
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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C.
Data type
boolean
Description
Exclusion Criteria Acrocyanosis, Jaundice, Splenomegaly.
Data type
boolean
Description
such as -Type 2 diabetes -Current or history of rheumatoid arthritis or temporal arthritis
Data type
boolean
Description
-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.
Data type
boolean
Description
-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.
Data type
boolean
Description
Exclusion Criteria Alcohol / Drug Consumption
Data type
boolean
Description
Exclusion Criteria Other Conditions
Data type
boolean
Description
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Description
Please report medication(s) as specified in the protocol and fill in the Medication section.
Data type
boolean
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
Diagnosis
Data type
text
Description
Status
Data type
text
Description
VITAL SIGNS
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Respiratory Rate
Data type
integer
Measurement units
- breaths/min
Description
HEMATOLOGY / BIOCHEMISTRY
Description
HEMATOLOGY
Description
Result below
Data type
float
Measurement units
- g/dL
Description
Result below
Data type
integer
Description
Result below
Data type
text
Description
Result below
Data type
text
Description
Result below
Data type
float
Measurement units
- abs
Description
Result below
Data type
integer
Measurement units
- /l
Description
Result below
Data type
text
Description
Result below
Data type
text
Description
Result below
Data type
text
Description
Result below
Data type
text
Description
BIOCHEMISTRY
Description
BUN
Data type
float
Measurement units
- mg/dL
Description
Result below
Data type
float
Measurement units
- mg/dL
Description
AST/SGOT
Data type
float
Measurement units
- U/L
Description
ALT/SGPT
Data type
float
Measurement units
- U/L
Description
Cholesterol
Data type
float
Description
Creatine phosphokinase
Data type
float
Description
Serum Haptoglobin
Data type
float
Measurement units
- mg/dL
Description
Please complete the following informationwith LDH isoenzymes if the grade 2 or greater LDH is observed (> 1.5 ULN)
Data type
text
Description
LDH
Description
URINALYSIS
Description
Urinalysis (Dipstick) Test
Description
Result
Data type
integer
Description
Proteins (via dipstick)
Data type
text
Description
Glucose (via dipstick)
Data type
text
Description
Ketones (via dipstick)
Data type
text
Description
Blood and myoglobin (via dipstick)
Data type
text
Description
Bilirubin (via dipstick)
Data type
text
Description
Urobilinogen (via dipstick)
Data type
text
Description
Nitrites (via dipstick)
Data type
text
Description
Leukocyte esterase (via dipstick)
Data type
text
Description
SCREENING CONCLUSION
Description
only SAEs related to study participation or to a concurrent medication need to be considered and reported
Data type
boolean
Description
total number of SAEs
Data type
integer
Description
Was the subject withdrawn prior to randomisation or first vaccination?
Data type
boolean
Description
Reason for failure
Data type
text
Description
Specify Other
Data type
text
Description
undefined item
Data type
integer
Description
Who made the decision
Data type
text
Description
INVESTIGATOR'S SIGNATURE
Description
Investigator's Confirmation
Data type
date
Description
Investigator's signature
Data type
text
Description
Printed Investigator's name:
Data type
text
Similar models
Screening Visit
- StudyEvent: ODM