ID

30018

Description

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially blinded, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB/Hib-MenAC vaccine as compared to Tritanrix™ HepB/Hiberix™ when administered to healthy infants at 2, 4, 6 months of age, who have received a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Concomitant Vaccination

Keywords

Versions (2)
  1. 7/11/17 7/11/17 -
  2. 5/4/18 5/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Concomitant Vaccination 100791

English

Concomitant Vaccination Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

1 forms  
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Description

vaccine

Data type

integer

Alias
UMLS CUI [1]
C0042210
Trade/Generic Name
Description

Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Description

Administration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
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Similar models

Concomitant Vaccination Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042210 (UMLS CUI [1])
vaccine
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
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