ID

30010

Beschreibung

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: Visit 3, Month 4, 56-69 days after Visit 2, Dose 3

Stichworte

Hepatitis-B-Vakzine

Klinische Studie [Dokumenttyp]

Bordetella pertussis

Hepatitis B

Haemophilus influenzae Typ b

Tetanus

Diphtherie

Vakzination

11.07.17 11.07.17 -
04.05.18 04.05.18 - Sarah Riepenhausen

Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Mai 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren

Itemgroup Kommentare für :

Item Kommentare für :

Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Visit 3 100791

Modell
Details

Visit 3 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

1 Formulare

StudyEvent: ODM
1. Visit 3 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Check for Study Continuation

Item Group

Check for Study Continuation

C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)

subject return for visit

Item

Did the subject come at visit 3 ?

integer

C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

subject return for visit 2

Code List

Did the subject come at visit 3 ?

CL Item

Yes, please complete the next pages. (1)

CL Item

No, please specify (2)

reason for study discontinuation

Item

Please tick the ONE most appropriate reason and skip the following pages of this visit.

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Code List

Please tick the 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)

SAE Number

Item

SAE Number

integer

C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

AE Number

Item

AE Number or Code

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Other reason for Study Discontinuation

Item

Other reason for Study Discontinuation

text

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Item

reason for study discontinuation

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

non administration

Code List

reason for study discontinuation

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Pre-Vaccination Assessment

Item Group

Pre-Vaccination Assessment

C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)

Temperature

Item

Temperature

float

C0005903 (UMLS CUI [1])

Vaccine Administration

Item Group

Vaccine Administration, Dose 3, Tritanrix-HepB/Hib-MenAC Vaccine OR Tritanrix-HepB/Hiberix Vaccine

C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C2240392 (UMLS CUI-4)

Date of Vaccine Administration

Item

Date of Vaccine Administration

date

C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])

Vaccine Administration

Item

Vaccine Administration

integer

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration

CL Item

Tritanrix-HepB/Hib-MenAC Vaccine (1)

CL Item

Tritanrix-HepB/Hiberix Vaccine (2)

CL Item

Replacement vial (3)

CL Item

Wrong vial number (4)

CL Item

Not administered (5)

Wrong vial number

Item

Wrong vial number

integer

C0184301 (UMLS CUI [1])

Administration Side

Item

Administration Side

text

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Site

Item

Administration Site

text

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Route

Item

Administration Route

text

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

reason for non administration

Item

Please tick the major reason for non administration

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

reason for non administration

Code List

Please tick the major reason for non administration

CL Item

Serious adverse event (1)

CL Item

Non-Serious adverse event (2)

CL Item

Other (3)

Serious adverse event Number

Item

Serious adverse event Number

integer

C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Non-serious adverse event Number

Item

Non-serious adverse event Number

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

reason for non administration

Item

reason for non administration, if other please specify

text

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Item

Please tick who made the decision

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Code List

Please tick who made the decision

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Study vaccine Administration

Item

Has the study vaccine been administered according to the Protocol ?

boolean

C2368628 (UMLS CUI [1])

Study vaccine Administration Side

Item

Study vaccine Administration: Side

integer

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration Side

Code List

Study vaccine Administration: Side

CL Item

Left (1)

CL Item

Right (2)

Study vaccine Administration Site

Item

Study vaccine Administration: Site

integer

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration Site

Code List

Study vaccine Administration: Site

CL Item

Deltoid (1)

CL Item

Thigh (2)

CL Item

Buttock (3)

Study vaccine Administration Route

Item

Study vaccine Administration: Route

integer

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration Route

Code List

Study vaccine Administration: Route

CL Item

I.M. (1)

CL Item

S.C. (2)

Adverse Events, Post-Vaccination Observation

Item Group

Adverse Events, Post-Vaccination Observation

C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)

serious or non-serious unsolicited adverse events

Item

Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?

integer

C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

serious or non-serious unsolicited adverse events

Code List

Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?

CL Item

Information not retrievable (1)

CL Item

No (2)

CL Item

Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (3)

CL Item

No Vaccine administered (4)

Solicited Adverse Events - Local Symptoms

Item Group

Solicited Adverse Events - Local Symptoms

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0877248 (UMLS CUI-4)

symptoms

Item

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

text

C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])

symptoms

Code List

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

CL Item

Information not available (U)

CL Item

No vaccine administered (NA)

CL Item

No (N)

CL Item

Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)

Redness

Item

Redness

boolean

C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Redness

Item

Redness, size (mm)

float