ID

33302

Beschreibung

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains information about general study notes which includes Elimination criteria, warnings and precautions and contraindications. It's for all workbooks.

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

Stichworte

Versionen (2)
  1. 04.11.18 04.11.18 -
  2. 05.12.18 05.12.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947

Englisch

Elimination criteria, warnings and precautions, contraindication

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschreibung

Workbook Number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Date of recording
Beschreibung

Date of recording

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0442711
ELIMINATION CRITERIA DURING THE STUDY
Beschreibung

ELIMINATION CRITERIA DURING THE STUDY

Alias
UMLS CUI-1
C0013893
Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
Beschreibung

Chronic administration definition: more than 14 days

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0021081
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C0001617
UMLS CUI [3,1]
C0683607
UMLS CUI [3,2]
C0304604
UMLS CUI [4,1]
C0683607
UMLS CUI [4,2]
C2065041
Major congenital defects or serious chronic illness
Beschreibung

Major congenital defects/ serious chronic illness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required)
Beschreibung

Immunosuppressive/ immunodeficient condition based on medical history and physical examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0021051
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0021051
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C1298908
UMLS CUI [3,3]
C1514873
Administration of immunoglobulins and/or any blood derived products during the study period
Beschreibung

Administration of immunoglobulins and/or any blood derived products during study period

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the entire study period.
Beschreibung

This criteria should be checked for all subjects at each scheduled visit only, subsequent to the first visit.

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0042210
UMLS CUI [2,4]
C1507394
WARNINGS AND PRECAUTIONS
Beschreibung

WARNINGS AND PRECAUTIONS

Alias
UMLS CUI-1
C1882442
UMLS CUI-2
C0871599
Local reactions at injection site: pain, redness and swelling
Beschreibung

Local reactions at injection site: pain, redness and swelling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853813
UMLS CUI [1,2]
C2700396
UMLS CUI [2]
C0030193
UMLS CUI [3]
C0332575
UMLS CUI [4]
C0038999
General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness.
Beschreibung

General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness

Datentyp

boolean

Alias
UMLS CUI [1]
C0159028
UMLS CUI [2]
C0022107
UMLS CUI [3]
C0010399
UMLS CUI [4]
C1971624
UMLS CUI [5]
C0042963
UMLS CUI [6]
C0011991
UMLS CUI [7]
C0015967
UMLS CUI [8]
C0013144
UMLS CUI [9]
C3887611
Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration
Beschreibung

Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration

Alias
UMLS CUI-1
C1882442
UMLS CUI-2
C3526553
UMLS CUI-3
C2368628
Fever within 48 hours of vaccination.
Beschreibung

rectal temperature equal to or more than 40.5 °C oral, axillary or tympanic temperature equal to or more than 40.0 °C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination
Beschreibung

Collapse, shock-like state

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344329
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
UMLS CUI [2,1]
C0036974
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0042196
Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting equal to or more than 3 hours
Beschreibung

Persistent, inconsolable crying

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Seizures with or without fever occurring within 3 days of vaccination
Beschreibung

Seizures with or without fever occurring within 3 days of vaccination.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0042196
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0042196
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschreibung

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0042196
Anaphylactic reaction following previous administration of vaccine(s)
Beschreibung

Anaphylactic reaction following vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Hypersensitivity to any component of the study or co-administered vaccines (10Pn-PD-DiT, DTPa-based combination vaccines, Havrix and Engerix-B) or signs of hypersensivity following previous immunizations
Beschreibung

Hypersensitivity to component of the study/ co-administered vaccines, signs of hypersensivity following vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0042210
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0042196
Acute disease at the time of vaccination. In case of acute disease, the study visit should be postponed until the illness has improved.
Beschreibung

Definition of acute disease: 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 fever, i.e. Oral/Axillary/Tympanic temperature below 37.5 °C / Recta l temperature below 38.0 °C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0040223
Febrile illness. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Beschreibung

Definition of Febrile illness: oral, axillary or tympanic temperature equal to or more than 37.5 °C rectal temperature equal to or more than 38.0 °C

Datentyp

boolean

Alias
UMLS CUI [1]
C0743841
UMLS CUI [2,1]
C0205421
UMLS CUI [2,2]
C0042196
Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib
Beschreibung

Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib

Alias
UMLS CUI-1
C0205344
UMLS CUI-2
C0522473
UMLS CUI-3
C2368628
UMLS CUI-4
C1121707
UMLS CUI-5
C0909900
These vaccines are contra-indicated if the infant has experienced an encephalopathy occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
Beschreibung

Definition of encephalopathy: acute, severe central nervous system disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085584
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
UMLS CUI [2]
C0234421
UMLS CUI [3]
C0241526
UMLS CUI [4]
C0234533
UMLS CUI [5]
C0751495
EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION
Beschreibung

EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C2348568
Diagnosis of high risk disease for pneumococcal infections (such as HIV positive, sickle cell disease and splenectomized infants) will be evaluated according to medical judgement.
Beschreibung

Decision on withdrawal of the subject from the study will depend on the medical condition of the subject, the existence of a specific local vaccination program, and the availability of the registered pneumococcal vaccine. If Prevnar is made available through a targeted immunization program for these high risk groups, further participation in the COMPAS study would no longer be possible, and these subjects will need to be excluded from the study and referred to the specific Prevnar immunization program. Once excluded, subjects can not return to receive subsequent study vaccine doses, even if Prevnar would no longer be available.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0032269
UMLS CUI [2]
C0019699
UMLS CUI [3]
C0002895
UMLS CUI [4]
C0037995
For each case, where by mistake, vaccines with antigens common to the antigens contained in the study or co-administered vaccines are administered outside of the context of the study, the investigator will need to evaluate whether the subject can still continue participation in the study.
Beschreibung

Other administration of vaccines than study vaccines.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
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Ähnliche Modelle

Elimination criteria, warnings and precautions, contraindication

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
Workbook 1 (1)
CL Item
Workbook 2 (2)
CL Item
Workbook 3 (3)
Date of recording
Item
Date of recording
date
C0011008 (UMLS CUI [1,1])
C0442711 (UMLS CUI [1,2])
Item Group
ELIMINATION CRITERIA DURING THE STUDY
C0013893 (UMLS CUI-1)
Chronic use of immunosuppressants/ other immunemodifying drugs, limited dosis of prednisone (inhaled and topical steroids allowed)
Item
Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
boolean
C0205191 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
C0683607 (UMLS CUI [3,1])
C0304604 (UMLS CUI [3,2])
C0683607 (UMLS CUI [4,1])
C2065041 (UMLS CUI [4,2])
Major congenital defects/ serious chronic illness
Item
Major congenital defects or serious chronic illness
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Immunosuppressive/ immunodeficient condition based on medical history and physical examination
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required)
boolean
C0262926 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C1298908 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
Administration of immunoglobulins and/or any blood derived products during study period
Item
Administration of immunoglobulins and/or any blood derived products during the study period
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Use of any investigational/non-registered product (drug or vaccine) ( except for study vaccine(s) )
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the entire study period.
boolean
C0013230 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C1507394 (UMLS CUI [2,4])
Item Group
WARNINGS AND PRECAUTIONS
C1882442 (UMLS CUI-1)
C0871599 (UMLS CUI-2)
Local reactions at injection site: pain, redness and swelling
Item
Local reactions at injection site: pain, redness and swelling
boolean
C0853813 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
C0332575 (UMLS CUI [3])
C0038999 (UMLS CUI [4])
General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness
Item
General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness.
boolean
C0159028 (UMLS CUI [1])
C0022107 (UMLS CUI [2])
C0010399 (UMLS CUI [3])
C1971624 (UMLS CUI [4])
C0042963 (UMLS CUI [5])
C0011991 (UMLS CUI [6])
C0015967 (UMLS CUI [7])
C0013144 (UMLS CUI [8])
C3887611 (UMLS CUI [9])
Item Group
Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration
C1882442 (UMLS CUI-1)
C3526553 (UMLS CUI-2)
C2368628 (UMLS CUI-3)
Fever
Item
Fever within 48 hours of vaccination.
boolean
C0015967 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Collapse, shock-like state
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination
boolean
C0344329 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Persistent, inconsolable crying
Item
Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting equal to or more than 3 hours
boolean
C2721683 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Seizures with or without fever occurring within 3 days of vaccination.
Item
Seizures with or without fever occurring within 3 days of vaccination
boolean
C0036572 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0036572 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0522473 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Anaphylactic reaction following vaccination
Item
Anaphylactic reaction following previous administration of vaccine(s)
boolean
C0002792 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Hypersensitivity to component of the study/ co-administered vaccines, signs of hypersensivity following vaccination
Item
Hypersensitivity to any component of the study or co-administered vaccines (10Pn-PD-DiT, DTPa-based combination vaccines, Havrix and Engerix-B) or signs of hypersensivity following previous immunizations
boolean
C0020517 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Acute illness at vaccination time
Item
Acute disease at the time of vaccination. In case of acute disease, the study visit should be postponed until the illness has improved.
boolean
C0001314 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Febrile illness, deferral of vaccination
Item
Febrile illness. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
boolean
C0743841 (UMLS CUI [1])
C0205421 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Item Group
Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib
C0205344 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
C2368628 (UMLS CUI-3)
C1121707 (UMLS CUI-4)
C0909900 (UMLS CUI-5)
Encephalopathy after vaccination, generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures
Item
These vaccines are contra-indicated if the infant has experienced an encephalopathy occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
boolean
C0085584 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0234421 (UMLS CUI [2])
C0241526 (UMLS CUI [3])
C0234533 (UMLS CUI [4])
C0751495 (UMLS CUI [5])
Item Group
EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION
C0013893 (UMLS CUI-1)
C2348568 (UMLS CUI-2)
High risk disease for pneumococcal infection (HIV, sickle cell disease, splenectomized infants)
Item
Diagnosis of high risk disease for pneumococcal infections (such as HIV positive, sickle cell disease and splenectomized infants) will be evaluated according to medical judgement.
boolean
C0012634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0032269 (UMLS CUI [1,3])
C0019699 (UMLS CUI [2])
C0002895 (UMLS CUI [3])
C0037995 (UMLS CUI [4])
Other administration of vaccines than study vaccines.
Item
For each case, where by mistake, vaccines with antigens common to the antigens contained in the study or co-administered vaccines are administered outside of the context of the study, the investigator will need to evaluate whether the subject can still continue participation in the study.
boolean
C0205394 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
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