ID

33458

Beschrijving

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Trefwoorden

Versies (1)
  1. 10-12-18 10-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

10 december 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Engels

Visit 4: Inclusion Criteria

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Subject Number
Beschrijving

Subject Number

Datatype

integer

Eligibility check
Beschrijving

Eligibility check

Did the subject meet all the entry criteria?
Beschrijving

Did the subject meet all the entry criteria?

Datatype

boolean

If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Beschrijving

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

Datatype

text

Inclusion Criteria
Beschrijving

Inclusion Criteria

For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Beschrijving

For subjects receiving Plain PRP followed by DTPw-HBV Kft:

Datatype

text

Terug naar het begin van de pagina

Similar models

Visit 4: Inclusion Criteria

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Eligibility check
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Item
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
text
Item Group
Inclusion Criteria
Item
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
text
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Code List
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
CL Item
A male or female infant, 16 to 19 months of age, who completed the primary vaccination course in the study DTPw-HBV=Hib Kft-001 (1)
CL Item
Subject 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 (2)
CL Item
Written informed consent obtained from the parent or guardian of the subject (3)
CL Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study (4)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial