ID

32062

Description

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is for documentation of demographics, informed consent and randomization/treatment number. To be filled in at Visit 1. Timing: Day 0 Age: 6 weeks +/- 1 week

Lien

https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1

Mots-clés

Versions (2)
  1. 16/10/2018 16/10/2018 - Sarah Riepenhausen
  2. 16/10/2018 16/10/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16 de outubro de 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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GSK oral HRV vaccine given with OPV in infants NCT00139334

Anglais

Demographics and Administrative Data

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date
Description

Informed Consent Date

Type de données

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Type de données

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Race
Description

Race

Type de données

integer

Alias
UMLS CUI [1]
C0034510
If other Race, please specify
Description

Other Race

Type de données

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
Height
Description

Height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Randomisation/Treatment Allocation
Description

Randomisation/Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Description

Treatment number

Type de données

text

Alias
UMLS CUI [1]
C1522541
Retour au début de la page

Similar models

Demographics and Administrative Data

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East and South East Asian (5)
CL Item
South Asian (6)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
CL Item
Bangladeshi (97)
CL Item
other (9)
Other Race
Item
If other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Randomisation/Treatment Allocation
C0034656 (UMLS CUI-1)
Treatment number
Item
Record treatment number
text
C1522541 (UMLS CUI [1])
Retour au début de la page 

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