ID
36102
Description
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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00344318
Mots-clés
Versions (2)
- 09/04/2019 09/04/2019 -
- 15/04/2019 15/04/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
15 avril 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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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
Description
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Description
Follow-up studies, Contact
Type de données
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
Description
Reason for no contact
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0332158
- UMLS CUI [1,4]
- C0566251
Description
Specification of reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348235
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
SAE during study period
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347804
Description
SAE Numbers
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
Treatment blind broken
Type de données
text
Alias
- UMLS CUI [1]
- C3897431
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3897431
Description
Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3897431
Description
Other reason for treatment blind broken
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C3897431
Description
Elimination criteria
Type de données
text
Alias
- UMLS CUI [1]
- C0680251
Description
Elimination criteria, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Description
Withdrawal of subject
Type de données
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Description
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.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
Description
SAE Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
AE Number/ solicited AE code
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
Description
Protocol violation, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
Other reason for withdrawal, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C2348235
Description
Decision taken
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0805839
Description
If you tick No, please give details in Adverse Events section
Type de données
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Printed Investigator's name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
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])