ID

33110

Description

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

Keywords

Versions (1)
  1. 11/28/18 11/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 28, 2018

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License

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

English

Visit 1: Eligibility Form

1 forms  
Administrative data
Description

Administrative data

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Eligibility check
Description

Eligibility check

Did the subject meet all the entry criteria?
Description

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

Data type

integer

Inclusion Criteria
Description

Inclusion Criteria

Tick "No" for any inclusion criteria subject failed
Description

Tick "No" for any inclusion criteria subject failed

Data type

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.
Description

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.

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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.
Description

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.

Data type

boolean

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

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

Data type

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).
Description

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).

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

warrants deferral of the vacination

Data type

boolean

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

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

Data type

boolean

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

16.A family history of congenital or hereditary immunodeficiency.

Data type

boolean

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

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

Data type

boolean

18.Major congenital defects or serious chronic illness.
Description

18.Major congenital defects or serious chronic illness.

Data type

boolean

19.History of any neurologic disorders or seizures
Description

19.History of any neurologic disorders or seizures

Data type

boolean

20.Acute disease at the time of enrollment.
Description

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Randomisation/Treatment allocation
Description

Randomisation/Treatment allocation

Record treatment number
Description

Record treatment number

Data type

integer

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Similar models

Visit 1: Eligibility Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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