ID

42515

Description

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.

Link

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

Keywords

Versions (1)
  1. 8/11/21 8/11/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 11, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393

English

Laboratory Reference Ranges

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Centre number
Description

Centre number

Data type

integer

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

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Laboratory name
Description

Performing laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Lab code
Description

(For GSK use only)

Data type

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
Description

Laboratory Reference Ranges

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

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).

Data type

date

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

Age range low

Data type

integer

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

Age range high

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

Measurement units
  • 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)
Description

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

Data type

integer

Measurement units
  • 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)
Description

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

Data type

integer

Measurement units
  • 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)
Description

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

Data type

integer

Measurement units
  • 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)
Description

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

Data type

float

Measurement units
  • 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)
Description

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

Data type

float

Measurement units
  • 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)
Description

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

Data type

float

Measurement units
  • 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)
Description

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

Data type

float

Measurement units
  • 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)
Description

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

Data type

integer

Measurement units
  • 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)
Description

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

Data type

integer

Measurement units
  • 10^3/µL
Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C1299400
UMLS CUI [2,2]
C0005821
10^3/µL
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Similar models

Laboratory Reference Ranges

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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