ID
34924
Description
Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This forms contains information about concomitant medication/vaccination. Record any concomitant medication/vaccination, including any medication administered prophylactically in anticipation of reaction to the vaccination (analgesic, antipyretic). This section about concomitant medication/vaccination must be checked for final assessment at the end of the study.
Lien
https://clinicaltrials.gov/ct2/show/NCT00290277
Mots-clés
Versions (1)
- 04/02/2019 04/02/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
4 février 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.
Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277
Concomitant medication/vaccination
- StudyEvent: ODM
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Trade / generic name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Description
A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C0199176
Description
Total daily dose
Type de données
text
Alias
- UMLS CUI [1]
- C2826638
Description
Route of administration
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Start date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
If continuing at end of study, tick below.
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Medication continuing at end of study
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0444496
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Trade / (Generic) Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0042210
Description
Route of Administration
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Administration Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Similar models
Concomitant medication/vaccination
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2])
C0042210 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
C0444496 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])