ID

33110

Beskrivning

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Nyckelord

Versioner (1)
  1. 2018-11-28 2018-11-28 -
Rättsinnehavare

GSK group of companies

Uppladdad den

28 november 2018

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Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

Engelsk

Visit 1: Eligibility Form

1 Formulär  
Administrative data
Beskrivning

Administrative data

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Eligibility check
Beskrivning

Eligibility check

Did the subject meet all the entry criteria?
Beskrivning

Do not enter the subject into study if he/she failed any inclusion or exclusion criteria below

Datatyp

integer

Inclusion Criteria
Beskrivning

Inclusion Criteria

Tick "No" for any inclusion criteria subject failed
Beskrivning

Tick "No" for any inclusion criteria subject failed

Datatyp

text

1.Subjects who the investigator believes that their parent/guardian can and 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.
Beskrivning

1.Subjects who the investigator believes that their parent/guardian can and 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.

Datatyp

boolean

2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
Beskrivning

2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)

Datatyp

boolean

3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
Beskrivning

3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.

Datatyp

boolean

4.Written informed consent obtained from parent or guardian of the subject.
Beskrivning

4.Written informed consent obtained from parent or guardian of the subject.

Datatyp

boolean

5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beskrivning

5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Datatyp

boolean

6.Born after a normal gestation period (36 to 42 weeks).
Beskrivning

6.Born after a normal gestation period (36 to 42 weeks).

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
Beskrivning

Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry

Datatyp

text

7.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.
Beskrivning

7.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.

Datatyp

boolean

8.Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
Beskrivning

For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.

Datatyp

boolean

9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
Beskrivning

9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).

Datatyp

boolean

10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
Beskrivning

10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.

Datatyp

boolean

11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
Beskrivning

11. Previous vaccination against diphtheria, tetanus, and/or pertussis.

Datatyp

boolean

12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
Beskrivning

12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.

Datatyp

boolean

13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
Beskrivning

13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.

Datatyp

boolean

14.Gastroenteritis within 7 days preceeding the first study vaccine administration.
Beskrivning

warrants deferral of the vacination

Datatyp

boolean

15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Beskrivning

15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).

Datatyp

boolean

16.A family history of congenital or hereditary immunodeficiency.
Beskrivning

16.A family history of congenital or hereditary immunodeficiency.

Datatyp

boolean

17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Beskrivning

17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

Datatyp

boolean

18.Major congenital defects or serious chronic illness.
Beskrivning

18.Major congenital defects or serious chronic illness.

Datatyp

boolean

19.History of any neurologic disorders or seizures
Beskrivning

19.History of any neurologic disorders or seizures

Datatyp

boolean

20.Acute disease at the time of enrollment.
Beskrivning

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.r. axillary temperature <37.5°C/rectal temperature <38°C

Datatyp

boolean

21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Beskrivning

21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Datatyp

boolean

22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Beskrivning

22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

Datatyp

boolean

Randomisation/Treatment allocation
Beskrivning

Randomisation/Treatment allocation

Record treatment number
Beskrivning

Record treatment number

Datatyp

integer

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Similar models

Visit 1: Eligibility Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Eligibility check
Item
Did the subject meet all the entry criteria?
integer
Did the subject meet all the entry criteria?
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (1)
CL Item
No (tick all boxes corresponding to violations of any inclusion/exclusion criteria below) (2)
Item Group
Inclusion Criteria
Tick "No" for any inclusion criteria subject failed
Item
Tick "No" for any inclusion criteria subject failed
text
1.Subjects who the investigator believes that their parent/guardian can and 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.
Item
1.Subjects who the investigator believes that their parent/guardian can and 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
2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
Item
2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
boolean
3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
Item
3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
boolean
4.Written informed consent obtained from parent or guardian of the subject.
Item
4.Written informed consent obtained from parent or guardian of the subject.
boolean
5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Item
5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
6.Born after a normal gestation period (36 to 42 weeks).
Item
6.Born after a normal gestation period (36 to 42 weeks).
boolean
Item Group
Exclusion Criteria
Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
Item
Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
text
7.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.
Item
7.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.
boolean
8.Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
Item
8.Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
boolean
9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
Item
9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
boolean
10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
Item
10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
boolean
11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
Item
11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
boolean
12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
Item
12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
boolean
13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
Item
13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
boolean
14.Gastroenteritis within 7 days preceeding the first study vaccine administration.
Item
14.Gastroenteritis within 7 days preceeding the first study vaccine administration.
boolean
15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Item
15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
boolean
16.A family history of congenital or hereditary immunodeficiency.
Item
16.A family history of congenital or hereditary immunodeficiency.
boolean
17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Item
17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
18.Major congenital defects or serious chronic illness.
Item
18.Major congenital defects or serious chronic illness.
boolean
19.History of any neurologic disorders or seizures
Item
19.History of any neurologic disorders or seizures
boolean
20.Acute disease at the time of enrollment.
Item
20.Acute disease at the time of enrollment.
boolean
21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Item
21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Item
22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
Item Group
Randomisation/Treatment allocation
Record treatment number
Item
Record treatment number
integer
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