ID

33184

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 (2)
  1. 11/30/18 11/30/18 -
  2. 11/30/18 11/30/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 30, 2018

DOI

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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 3: Study Continuation Check

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for visit 3?
Description

Did the subject return for visit 3?

Data type

boolean

If yes, please complete all forms for Visit 3
Description

If yes, please complete all forms for Visit 3

Data type

text

If No, record ONE most appropriate reason and skip the following pages of this visit
Description

If No, record ONE most appropriate reason and skip the following pages of this visit

Data type

text

If SAE, record the SAE number
Description

If SAE, record the SAE number

Data type

integer

If Non-SAE, record the unsolicited AE number
Description

If Non-SAE, record the unsolicited AE number

Data type

integer

If Other, specify
Description

e.g., consent withdrawal, protocol violation, etc.

Data type

text

Who took the decision?
Description

Who took the decision?

Data type

text

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Visit 3: Study Continuation Check

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Check for Study Continuation
Did the subject return for visit 3?
Item
Did the subject return for visit 3?
boolean
If yes, please complete all forms for Visit 3
Item
If yes, please complete all forms for Visit 3
text
Item
If No, record ONE most appropriate reason and skip the following pages of this visit
text
If No, record ONE most appropriate reason and skip the following pages of this visit
Code List
If No, record ONE most appropriate reason and skip the following pages of this visit
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If Non-SAE, record the unsolicited AE number
Item
If Non-SAE, record the unsolicited AE number
integer
If Other, specify
Item
If Other, specify
text
Item
Who took the decision?
text
Who took the decision?
Code List
Who took the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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