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ID
35502
Beschreibung
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
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- 06.03.19 06.03.19 -
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GSK group of companies
Hochgeladen am
6. März 2019
DOI
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Ähnliche Modelle
Screening Visit
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Elimination Criteria
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
Elimination Criteria Investigational or Non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
Elimination Criteria Chronic Immunosuppressants Administration
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
boolean
Elimination Criteria Unplanned Vaccination
Item
Administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the first dose of study vaccine and ending one month (minimum 30 days) after the last dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7days preceding or at least 7 days following any vaccine dose (i.e.; after collection of the study’s 7-day safety data).
boolean
Elimination Criteria Immunoglobulins Administration
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
Elimination Criteria Drug/Alcohol Abuse
Item
Drug and/or alcohol abuse.
boolean
Contraindications to Vaccination
Item
The following adverse events (AEs) constitute absolute contraindications to further administration of the study vaccine if any of these AEs occur during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator.
text
Contraindications to Vaccination Anaphylactic Reaction
Item
Anaphylactic reaction following the administration of vaccine(s).
boolean
Contraindications to Vaccination Immunosuppressive or Immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
Contraindications to Vaccination AE
Item
The following AEs constitute contraindications to administration of the study vaccines at that point in time
text
Contraindications to Vaccination Acute Disease
Item
Acute disease at the time of vaccination.
boolean
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 vaccines or the diseases caused by S. pneumoniae or Haemophilus influenzae 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 vaccines or the diseases caused by S. pneumoniae or Haemophilus influenzae under study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Center number:
Item
Center number:
integer
Birth Date
Item
Date of Birth:
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
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
If Other, please specify
text
Eligibility Criteria Question
Item
Did the subject meet all the entry criteria?
boolean
Inclusion Criteria Subject Protocol Compliance
Item
Subjects who the investigator believes 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
Inclusion Criteria Age
Item
A male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health.
boolean
Inclusion Criteria Written Consent
Item
Written informed consent obtained from the subject.
boolean
Exclusion Criteria Previous Vaccination
Item
Previous vaccination against Streptococcus pneumoniae (with a licensed vaccine or with an investigational candidate vaccine).
boolean
Exclusion Criteria Previous Vaccination with Diphtheria/Tetanus Toxoids
Item
Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
boolean
Exclusion Criteria Unplanned 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 first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
boolean
Exclusion Criteria 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 first vaccine dose.
boolean
Exclusion Criteria Planned Concomitant Vaccination
Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7 days preceding or at least 7 days following any vaccine dose.
boolean
Exclusion Criteria Administration of Immunoglobulins
Item
Administration of immunoglobulins and/or any blood products within the last 3 months.
boolean
Exclusion Criteria Bacterial Pneumonia
Item
Bacterial pneumonia within 3 years prior to 1st vaccination.
boolean
Exclusion Criteria Invasive Pneumococcal Disease
Item
Invasive pneumococcal disease (I.P.D) within 3 years prior to 1st vaccination.
boolean
Exclusion Criteria Thrombocytopenia / Bleeding Disorder.
Item
History of thrombocytopenia or bleeding disorder.
boolean
Exclusion Criteria Immunosuppressive or Immunodeficient Condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
Exclusion Criteria Allergy
Item
History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
boolean
Exclusion Criteria Administration Product Containing MPL or QS21.
Item
History of administration of an experimental/licensed product containing MPL or QS21.
boolean
Exclusion Criteria Neurologic/ Mental disorders
Item
Current serious neurologic or mental disorders.
boolean
Exclusion Criteria Inflammatory Processes
Item
Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
boolean
Exclusion Criteria Lymphoproliferative Disorders and Malignancies
Item
All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
boolean
Exclusion Criteria Acute Disease
Item
Acute disease at the time of enrolment.
boolean
Exclusion Criteria Acrocyanosis, Jaundice, Splenomegaly.
Item
Physical examination positive for acrocyanosis (peri-oral cyanosis and peripheral cyanosis of the hands/feet), jaundice, splenomegaly.
boolean
Exclusion Criteria Other Medical Conditions
Item
Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests at the discretion of the investigator
boolean
Exclusion Criteria Haematological Abnormalities
Item
Laboratory evidence of haematological abnormalities
boolean
Exclusion Criteria Bbiochemical Abnormalities
Item
Laboratory evidence of biochemical abnormalities (with the exception of elevated cholesterol levels)
boolean
Exclusion Criteria Alcohol / Drug Consumption
Item
History of chronic alcohol consumption and/or drug abuse.
boolean
Exclusion Criteria Other Conditions
Item
Other conditions that the principal investigator judges may interfere with study findings.
boolean
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
General Medical History Question
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue
text
CL Item
Current (1)
CL Item
Past (2)
Musculoskeletal and connective tissue
Item
Musculoskeletal and connective tissue
text
CL Item
Current (1)
CL Item
Past (2)
Cardiac
Item
Cardiac
text
CL Item
Current (1)
CL Item
Past (2)
Vascular
Item
Vascular
text
CL Item
Current (1)
CL Item
Past (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal
text
CL Item
Current (1)
CL Item
Past (2)
Gastrointestinal
Item
Gastrointestinal
text
CL Item
Current (1)
CL Item
Past (2)
Hepatobiliary
Item
Hepatobiliary
text
CL Item
Current (1)
CL Item
Past (2)
Renal and urinary
Item
Renal and urinary
text
CL Item
Current (1)
CL Item
Past (2)
Nervous system
Item
Nervous system
text
CL Item
Current (1)
CL Item
Past (2)
Eye
Item
Eye
text
CL Item
Current (1)
CL Item
Past (2)
Ear and labyrinth
Item
Ear and labyrinth
text
CL Item
Current (1)
CL Item
Past (2)
Endocrine
Item
Endocrine
text
CL Item
Current (1)
CL Item
Past (2)
Metabolism and nutrition
Item
Metabolism and nutrition
text
CL Item
Current (1)
CL Item
Past (2)
Blood and lymphatic system
Item
Blood and lymphatic system
text
CL Item
Current (1)
CL Item
Past (2)
Immune system (incl allergies, autoimmune disorders)
Item
Immune system (incl allergies, autoimmune disorders)
text
CL Item
Current (1)
CL Item
Past (2)
Infections and infestatio
Item
Infections and infestatio
text
CL Item
Current (1)
CL Item
Past (2)
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
text
CL Item
Current (1)
CL Item
Past (2)
Surgical and medical procedures
Item
Surgical and medical procedures
text
CL Item
Current (1)
CL Item
Past (2)
Other
Item
Other
text
CL Item
Current (1)
CL Item
Past (2)
Heart Rate
Item
Heart rate:
integer
Blood Pressure Systolic
Item
Blood pressure (systolic):
integer
Blood Pressure Diastolic
Item
Blood pressure (diastolic):
integer
Respiratory Rate
Item
Respiratory Rate:
integer
Hematology / Biochemistry Question
Item
Has a blood sample been taken for haematology/ biochemistry testing?
boolean
Date
Item
Date
date
Laboratory Name
Item
LABORATORY NAME:
text
Laboratory Code
Item
LAB CODE
integer
Hemoglobin
Item
[HB] Hemoglobin
float
Red Blood Cells
Item
[RBC] Red Blood Cells
integer
Platelets
Item
[PLA] Platelets
text
White Blood Cells
Item
[WBC] White Blood Cells
text
Neutrophils
Item
[NEU] Neutrophils
float
Lymphocytes
Item
[LYM] Lymphocytes
integer
Monocytes
Item
[MON] Monocytes
text
Eosinophils
Item
[EOS] Eosinophils
text
Basophils
Item
[BAS] Basophils
text
Reticulocytes
Item
[RET] Reticulocytes
text
BUN
Item
[BUN] BUN
float
Creatinine
Item
[CREA] Creatinine
float
AST/SGOT
Item
[AST] AST/SGOT
float
ALT/SGPT
Item
[ALT] ALT/SGPT
float
Cholesterol
Item
[CHOL] Cholesterol
float
Creatine phosphokinase
Item
[CPK] Creatine phosphokinase
float
Serum Haptoglobin
Item
[HAP] Serum Haptoglobin
float
Lactate Dehydrogenase
Item
[LDH] Lactate Dehydrogenase
text
LD1
Item
LD1
text
LD2
Item
LD2
text
LD3
Item
LD3
text
LD4
Item
LD4
text
LD5
Item
LD5
text
Urinalysis Question
Item
Has a urine sample been taken for dipstick?
boolean
Date
Item
Date
date
pH (via dipstick)
Item
pH (via dipstick)
integer
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
normal (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
CL Item
negtive (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
normal (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
Screening Conclusion
Item
Did the subject experience any Serious Adverse Event during screening?
boolean
total number of SAEs
Item
Specify total number of SAEs
integer
screening failure?
Item
Is the subject a screening failure?
boolean
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria). (1)
CL Item
Protocol violation (2)
CL Item
Serious adverse event (3)
CL Item
Consent withdrawal not due to a serious adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
Specify Other
Item
If Other, please specify
text
undefined item
Item
If SAE, Please specify SAE No. |__|__|
integer
CL Item
Investigator (1)
CL Item
Subject (2)
Investigator's Confirmation
Item
I confirm that I have reviewed the data in these screening forms 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.
date
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name:
Item
Printed Investigator's name:
text