ID

42515

Descrizione

Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Laboratory reference range for each laboratory test should be documented in this form. If the reference ranges for any test differ by age range, age units or sex, a separate form for each variation should be completed. Note that informed consent has to be obtained prior to any study procedure.

collegamento

https://clinicaltrials.gov/ct2/show/study/NCT00380393

Keywords

versioni (1)
  1. 11/08/21 11/08/21 -
Titolare del copyright

GlaxoSmithKline

Caricato su

11 agosto 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393

Inglese

Laboratory Reference Ranges

1 moduli  
Administrative Documentation
Descrizione

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Centre number
Descrizione

Centre number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0019994
UMLS CUI [1,2]
C0600091
Laboratory Reference Ranges
Descrizione

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Laboratory name
Descrizione

Performing laboratory name

Tipo di dati

text

Alias
UMLS CUI [1]
C3258037
Lab code
Descrizione

(For GSK use only)

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C0805701
UMLS CUI [2,1]
C2347796
UMLS CUI [2,2]
C0457083
Laboratory Reference Ranges
Descrizione

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Date these reference ranges became effective
Descrizione

Enter the reference range for each test. If the reference ranges for any test differ by age range, age units or sex, complete a separate version of this repeating item group for each variation (e.g., males 0-16, males 17-99, females 0- 16, females 17-99 years).

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0011008
Age range low
Descrizione

Age range low

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C0205251
Age range high
Descrizione

Age range high

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C0205250
Age units
Descrizione

(tick one box) In the original paper-based version of this clinical study report, 'weeks' was pre-selected for this item.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1519795
Sex
Descrizione

In the original paper-based version of this clinical study report, 'Male and Female reference range' was pre-selected for this item.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0079399
Lab Test Biochemistry: ALT (Low Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 5 U/L.

Tipo di dati

integer

Unità di misura
  • U/L
Alias
UMLS CUI [1]
C0008000
UMLS CUI [2,1]
C1272773
UMLS CUI [2,2]
C0201836
U/L
Lab Test Biochemistry: ALT (High Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 60 U/L.

Tipo di dati

integer

Unità di misura
  • U/L
Alias
UMLS CUI [1]
C0008000
UMLS CUI [2,1]
C1299400
UMLS CUI [2,2]
C0201836
U/L
Lab Test Biochemistry: Creatinine (Low Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 10 µmol/L.

Tipo di dati

integer

Unità di misura
  • µmol/L
Alias
UMLS CUI [1]
C0008000
UMLS CUI [2,1]
C1272773
UMLS CUI [2,2]
C0201975
µmol/L
Lab Test Biochemistry: Creatinine (High Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 60 µmol/L.

Tipo di dati

integer

Unità di misura
  • µmol/L
Alias
UMLS CUI [1]
C0008000
UMLS CUI [2,1]
C1299400
UMLS CUI [2,2]
C0201975
µmol/L
Lab Test Haematology: Haemoglobin (Low Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 8.0 g/dL.

Tipo di dati

float

Unità di misura
  • g/dL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1272773
UMLS CUI [2,2]
C0518015
g/dL
Lab Test Haematology: Haemoglobin (High Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 18 g/dL.

Tipo di dati

float

Unità di misura
  • g/dL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1299400
UMLS CUI [2,2]
C0518015
g/dL
Lab Test Haematology: WBC (White blood cells) total (Low Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 4.0 x 10^3/µL

Tipo di dati

float

Unità di misura
  • 10^3/µL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1272773
UMLS CUI [2,2]
C0023508
10^3/µL
Lab Test Haematology: WBC (White blood cells) total (High Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 17 x 10^3/µL

Tipo di dati

float

Unità di misura
  • 10^3/µL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1299400
UMLS CUI [2,2]
C0023508
10^3/µL
Lab Test Haematology: Platelets (Low Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 100 x 10^3/µL

Tipo di dati

integer

Unità di misura
  • 10^3/µL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1272773
UMLS CUI [2,2]
C0005821
10^3/µL
Lab Test Haematology: Platelets (High Reference Value)
Descrizione

In the original paper-based version of this clinical study report, this item was pre-filled with 800 x 10^3/µL

Tipo di dati

integer

Unità di misura
  • 10^3/µL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1299400
UMLS CUI [2,2]
C0005821
10^3/µL
Ritorna all'inizio della pagina

Similar models

Laboratory Reference Ranges

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
integer
C0019994 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Laboratory Reference Ranges
C0883335 (UMLS CUI-1)
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing laboratory code | Clinical study sponsor usage
Item
Lab code
text
C1882331 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C2347796 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
Item Group
Laboratory Reference Ranges
C0883335 (UMLS CUI-1)
Reference lab test reference range date in time
Item
Date these reference ranges became effective
date
C0883335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Age range low
Item
Age range low
integer
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
Age range high
Item
Age range high
integer
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Item
Age units
integer
C0001779 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Age units
Code List
Age units
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male reference range [M] (1)
(Comment:en)
CL Item
Female reference range [F] (2)
(Comment:en)
CL Item
Male and Female reference range (3)
(Comment:en)
Clinical Chemistry | lower limit of reference range ALT
Item
Lab Test Biochemistry: ALT (Low Reference Value)
integer
C0008000 (UMLS CUI [1])
C1272773 (UMLS CUI [2,1])
C0201836 (UMLS CUI [2,2])
Clinical Chemistry | upper limit of reference range ALT
Item
Lab Test Biochemistry: ALT (High Reference Value)
integer
C0008000 (UMLS CUI [1])
C1299400 (UMLS CUI [2,1])
C0201836 (UMLS CUI [2,2])
Clinical Chemistry | lower limit of reference range creatinine
Item
Lab Test Biochemistry: Creatinine (Low Reference Value)
integer
C0008000 (UMLS CUI [1])
C1272773 (UMLS CUI [2,1])
C0201975 (UMLS CUI [2,2])
Clinical Chemistry | upper limit of reference range creatinine
Item
Lab Test Biochemistry: Creatinine (High Reference Value)
integer
C0008000 (UMLS CUI [1])
C1299400 (UMLS CUI [2,1])
C0201975 (UMLS CUI [2,2])
Haematology | lower limit of reference range haemoglobin
Item
Lab Test Haematology: Haemoglobin (Low Reference Value)
float
C0018941 (UMLS CUI [1])
C1272773 (UMLS CUI [2,1])
C0518015 (UMLS CUI [2,2])
Haematology | upper limit of reference range haemoglobin
Item
Lab Test Haematology: Haemoglobin (High Reference Value)
float
C0018941 (UMLS CUI [1])
C1299400 (UMLS CUI [2,1])
C0518015 (UMLS CUI [2,2])
Haematology | lower limit of reference range WBC
Item
Lab Test Haematology: WBC (White blood cells) total (Low Reference Value)
float
C0018941 (UMLS CUI [1])
C1272773 (UMLS CUI [2,1])
C0023508 (UMLS CUI [2,2])
Haematology | upper limit of reference range WBC
Item
Lab Test Haematology: WBC (White blood cells) total (High Reference Value)
float
C0018941 (UMLS CUI [1])
C1299400 (UMLS CUI [2,1])
C0023508 (UMLS CUI [2,2])
Haematology | lower limit of reference range blood platelets
Item
Lab Test Haematology: Platelets (Low Reference Value)
integer
C0018941 (UMLS CUI [1])
C1272773 (UMLS CUI [2,1])
C0005821 (UMLS CUI [2,2])
Haematology | upper limit of reference range blood platelets
Item
Lab Test Haematology: Platelets (High Reference Value)
integer
C0018941 (UMLS CUI [1])
C1299400 (UMLS CUI [2,1])
C0005821 (UMLS CUI [2,2])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial