ID
30013
Descripción
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: Study Conclusion
Palabras clave
Versiones (2)
- 11/7/17 11/7/17 -
- 4/5/18 4/5/18 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
4 de mayo de 2018
DOI
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Licencia
Creative Commons BY-NC 3.0
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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Study Conclusion 100791
Study Conclusion Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791
Descripción
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Descripción
Serious Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
If yes, please give the total number of SAE's:
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Descripción
elimination criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0680251
Descripción
elimination criteria
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0680251
Descripción
withdrawn
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Descripción
If Yes, please specify
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Descripción
If Serious adverse event, please specify
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Descripción
If Non-serious adverse event, please specify
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Descripción
Protocol violation
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1709750
Descripción
If Other, please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Descripción
reason for withdrawal
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Descripción
Date of last contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Descripción
subject condition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Descripción
Investigators signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigators signature Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Descripción
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descripción
treatment blind broken
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0749659
- UMLS CUI [1,2]
- C2347038
Descripción
Was the treatment blind broken during the study?
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
Was the treatment blind broken during the study?
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Descripción
reason treatment blind broken
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Similar models
Study Conclusion Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791
C2348568 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0558080 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1705415 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])