ID
36102
Descripción
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
Palabras clave
Versiones (2)
- 9/4/19 9/4/19 -
- 15/4/19 15/4/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de abril de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Descripción
Follow-up studies, Contact
Tipo de datos
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
Descripción
Reason for no contact
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0332158
- UMLS CUI [1,4]
- C0566251
Descripción
Specification of reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348235
Descripción
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Descripción
SAE during study period
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347804
Descripción
SAE Numbers
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Descripción
Treatment blind broken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3897431
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3897431
Descripción
Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3897431
Descripción
Other reason for treatment blind broken
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C3897431
Descripción
Elimination criteria
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0680251
Descripción
Elimination criteria, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Descripción
Withdrawal of subject
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
Descripción
SAE Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Descripción
AE Number/ solicited AE code
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
Descripción
Protocol violation, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Descripción
Other reason for withdrawal, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C2348235
Descripción
Decision taken
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
If you tick No, please give details in Adverse Events section
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Printed Investigator's name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Follow-up studies, Study conclusion, Investigator's signature
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