ID
36102
Beschreibung
Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Follow-up studies, Study conclusion and Investigator's signature form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00344318
Stichworte
Versionen (2)
- 09.04.19 09.04.19 -
- 15.04.19 15.04.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. April 2019
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.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318
Follow-up studies, Study conclusion, Investigator's signature
- StudyEvent: ODM
Beschreibung
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Beschreibung
Follow-up studies, Contact
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0332158
- UMLS CUI [2,1]
- C0016441
- UMLS CUI [2,2]
- C0332158
- UMLS CUI [2,3]
- C0030551
- UMLS CUI [3,1]
- C0016441
- UMLS CUI [3,2]
- C0332158
- UMLS CUI [3,3]
- C0023226
Beschreibung
Reason for no contact
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0332158
- UMLS CUI [1,4]
- C0566251
Beschreibung
Specification of reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348235
Beschreibung
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
SAE during study period
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347804
Beschreibung
SAE Numbers
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beschreibung
Treatment blind broken
Datentyp
text
Alias
- UMLS CUI [1]
- C3897431
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3897431
Beschreibung
Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3897431
Beschreibung
Other reason for treatment blind broken
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C3897431
Beschreibung
Elimination criteria
Datentyp
text
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
Elimination criteria, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Beschreibung
Withdrawal of subject
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Beschreibung
tick one box only. If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
Beschreibung
SAE Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschreibung
AE Number/ solicited AE code
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
Beschreibung
Protocol violation, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschreibung
Other reason for withdrawal, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C2348235
Beschreibung
Decision taken
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
If you tick No, please give details in Adverse Events section
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Printed Investigator's name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
Follow-up studies, Study conclusion, Investigator's signature
- StudyEvent: ODM
C0332158 (UMLS CUI [1,2])
C0016441 (UMLS CUI [2,1])
C0332158 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
C0016441 (UMLS CUI [3,1])
C0332158 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
C0558080 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0681850 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])