ID

35995

Beschreibung

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Eligibility criteria form. It has to be filled in for Visit 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Stichworte

Versionen (2)
  1. 09.04.19 09.04.19 -
  2. 15.04.19 15.04.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. April 2019

DOI

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Creative Commons BY-NC 3.0
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Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

Englisch

Eligibility criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility criteria
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
Visit Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility check
Beschreibung

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

If you tick No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datentyp

text

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
Beschreibung

Gender, Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
Beschreibung

Compliance to requirements of the protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0023226
Written informed consent obtained from the parent or guardian of the subject.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beschreibung

No Disease (medical history and clinical examination)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C1456356
Born after a gestation period (between 36 and 42 weeks).
Beschreibung

Born after a gestation period

Datentyp

boolean

Alias
UMLS CUI [1]
C2114495
Exclusion Criterion
Beschreibung

Exclusion Criterion

Alias
UMLS CUI-1
C0680251
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 (active phase and 6 months safety follow-up).
Beschreibung

Other investigational drug/vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0042210
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Beschreibung

Chron administration is defined as more than 14 days.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0021081
UMLS CUI [2,1]
C0683607
UMLS CUI [2,2]
C2065041
UMLS CUI [3,1]
C0683607
UMLS CUI [3,2]
C3897353
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
Beschreibung

Administration of other vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1518384
UMLS CUI [1,3]
C0750503
UMLS CUI [1,4]
C0040223
UMLS CUI [1,5]
C0042196
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination)
Beschreibung

Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae (excepted hepatitis B vaccination)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0012559
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0199809
UMLS CUI [3,1]
C0205156
UMLS CUI [3,2]
C0199818
UMLS CUI [4,1]
C0205156
UMLS CUI [4,2]
C0004886
UMLS CUI [5,1]
C0205156
UMLS CUI [5,2]
C0042196
UMLS CUI [5,3]
C0038410
UMLS CUI [6,1]
C0332300
UMLS CUI [6,2]
C0474232
History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
Beschreibung

History of/intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012546
UMLS CUI [2,1]
C0277557
UMLS CUI [2,2]
C0012546
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0039614
UMLS CUI [4,1]
C0277557
UMLS CUI [4,2]
C0039614
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0043167
UMLS CUI [6,1]
C0277557
UMLS CUI [6,2]
C0043167
UMLS CUI [7,1]
C0262926
UMLS CUI [7,2]
C0019163
UMLS CUI [8,1]
C0277557
UMLS CUI [8,2]
C0019163
UMLS CUI [9,1]
C0262926
UMLS CUI [9,2]
C0032371
UMLS CUI [10,1]
C0277557
UMLS CUI [10,2]
C0032371
UMLS CUI [11,1]
C0262926
UMLS CUI [11,2]
C0121772
UMLS CUI [12,1]
C0277557
UMLS CUI [12,2]
C0121772
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
Beschreibung

Allergic disease/reactions to vaccine component (including diphtheria toxoid)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0332257
UMLS CUI [3,2]
C0012551
History of seizures or neurological disease.
Beschreibung

History of seizures/neurological disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0027765
Acute disease at the time of enrolment.
Beschreibung

Definition: 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 or mild upper respiratory infections with or without lowgrade febrile illness, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Beschreibung

Immunosuppression (based on medical hisytory and physical examination)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C0021051
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0031809
A family history of congenital or hereditary immunodeficiency.
Beschreibung

Family history of congenital or hereditary immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0853602
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0021051
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
Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
Beschreibung

Immunoglobulins, blood products

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
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Ähnliche Modelle

Eligibility criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility criteria
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
WB 1 (1)
CL Item
WB 2 (2)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility check
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Gender, Age
Item
Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Compliance to requirements of the protocol
Item
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Informed consent
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
No Disease (medical history and clinical examination)
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Born after a gestation period
Item
Born after a gestation period (between 36 and 42 weeks).
boolean
C2114495 (UMLS CUI [1])
Item Group
Exclusion Criterion
C0680251 (UMLS CUI-1)
Other investigational drug/vaccine
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 (active phase and 6 months safety follow-up).
boolean
C0205394 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Chronic use of Immunosuppressants/ immunemodifying drugs (excluding inhaled/topical steroids)
Item
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (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])
C0683607 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C0683607 (UMLS CUI [3,1])
C3897353 (UMLS CUI [3,2])
Administration of other vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
boolean
C2368628 (UMLS CUI [1,1])
C1518384 (UMLS CUI [1,2])
C0750503 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae (excepted hepatitis B vaccination)
Item
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination)
boolean
C0205156 (UMLS CUI [1,1])
C0012559 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C0199809 (UMLS CUI [2,2])
C0205156 (UMLS CUI [3,1])
C0199818 (UMLS CUI [3,2])
C0205156 (UMLS CUI [4,1])
C0004886 (UMLS CUI [4,2])
C0205156 (UMLS CUI [5,1])
C0042196 (UMLS CUI [5,2])
C0038410 (UMLS CUI [5,3])
C0332300 (UMLS CUI [6,1])
C0474232 (UMLS CUI [6,2])
History of/intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b
Item
History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
boolean
C0262926 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0277557 (UMLS CUI [2,1])
C0012546 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0039614 (UMLS CUI [3,2])
C0277557 (UMLS CUI [4,1])
C0039614 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5,1])
C0043167 (UMLS CUI [5,2])
C0277557 (UMLS CUI [6,1])
C0043167 (UMLS CUI [6,2])
C0262926 (UMLS CUI [7,1])
C0019163 (UMLS CUI [7,2])
C0277557 (UMLS CUI [8,1])
C0019163 (UMLS CUI [8,2])
C0262926 (UMLS CUI [9,1])
C0032371 (UMLS CUI [9,2])
C0277557 (UMLS CUI [10,1])
C0032371 (UMLS CUI [10,2])
C0262926 (UMLS CUI [11,1])
C0121772 (UMLS CUI [11,2])
C0277557 (UMLS CUI [12,1])
C0121772 (UMLS CUI [12,2])
Allergic disease/reactions to vaccine component (including diphtheria toxoid)
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
boolean
C1527304 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0332257 (UMLS CUI [3,1])
C0012551 (UMLS CUI [3,2])
History of seizures/neurological disease
Item
History of seizures or neurological disease.
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0027765 (UMLS CUI [2,2])
Acute disease
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Immunosuppression (based on medical hisytory and physical examination)
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
boolean
C4048329 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
Family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0021051 (UMLS CUI [2,3])
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])
Immunoglobulins, blood products
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
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