ID
38314
Description
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B
Mots-clés
Versions (2)
- 08/10/2019 08/10/2019 -
- 09/10/2019 09/10/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
9 octobre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)
Visit 3 - Laboratory Tests; Phone Contact Month 5; Visit 4 - Pre-Vacciantion Assessment; Vaccine Administration
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Month 5 - Phone Contact
Alias
- UMLS CUI-1
- C0337611
- UMLS CUI-2
- C0039457
- UMLS CUI-3
- C0439231
Description
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0332152
Description
Pre- vaccination temperature
Type de données
float
Unités de mesure
- °F
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [2]
- C0005903
Description
Temperature Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Description
Vaccine Administration (Engerix-B- Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0116078
Description
(only one box must be checked)
Type de données
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Vaccination Side/ Site Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Description
Has the study vaccine been administered according to the Protocol?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Please check all items
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vaccine Administration (Infanrix Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1964896
Description
(only one box must be checked)
Type de données
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Vaccination Side/ Site Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Description
Has the study vaccine been administered according to the Protocol?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Please check all items
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C234856
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vaccine Administration (Prevnar Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0876134
Description
(only one box must be checked)
Type de données
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Vaccination Side/ Site Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Description
Has the study vaccine been administered according to the Protocol?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Please check all items
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C234856
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vaccine Administration (HibTITER Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1524027
Description
(only one box must be checked)
Type de données
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Vaccination Side/ Site Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vaccine Administration (Comvax Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0535643
Description
(only one box must be checked)
Type de données
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Vaccination Side/ Site Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Description
Has the study vaccine been administered according to the Protocol?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Please check all items
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C234856
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Visit 3 - Laboratory Tests; Phone Contact Month 5; Visit 4 - Pre-Vacciantion Assessment; Vaccine Administration
C0039457 (UMLS CUI-2)
C0439231 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0449687 (UMLS CUI [1,2])
C0116078 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C1964896 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C234856 (UMLS CUI [1,2])
C0876134 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C234856 (UMLS CUI [1,2])
C1524027 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C0535643 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C234856 (UMLS CUI [1,2])