ID

37832

Description

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on the actual vaccine administration as well as warnings and contraindiciations to the vaccination which should be checked beforehand, and is to be filled in repeatedly during the study at the vaccination visits, which are Visits 1, 2, 3 (all cohorts), 5 (all cohorts except the 3+0 ("EPI") schedule without the booster) and 8 (all cohorts).

Keywords

Versions (1)
  1. 8/26/19 8/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed, and HIV-negative infants - NCT00829010

English

Vaccine Administration, Contraindications, Precautions

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Description

There is no study vaccination at Visit 5 in the EPI/3+0 schedule cohort.

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Vaccination Dose
Description

Dose 1 is at Visit 1. Dose 2 is at Visit 2. Dose 3 is at Visit 3. The Booster Dose of 10Pn-PD-DiT is at Visit 5 (not applicable to the EPI/3+0 schedule HIV-neg. cohort). The Booster Dose of DTPw-HBV/Hib is at Visit 8. Please note that in the 2+1 schedule HIV-neg. cohort, the pneumococcal study vaccine is not administered at Visit 2. However, this Visit is still designated as "Dose 2", as the second dose of the DTPw-HBV/Hib vaccine is administered at this Visit.

Data type

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Date of administration of Vaccine
Description

fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Site of temperature measurement
Description

Site of temperature measurement

Data type

text

Alias
UMLS CUI [1]
C0489453
Contraindications to vaccination
Description

Contraindications to vaccination

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0042196
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines
Description

This adverse event (AE) constitutes an absolute contraindication to further administration of the study vaccines (10Pn-PD-DiT, Rotarix and Tritanrix-HepB/Hib); if this AE occurs during the study, the subject must not receive additional doses of the study vaccines but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C1705248
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C0013230
Fever
Description

Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. These AEs constitute contraindications to administration of the study vaccines (10Pn-PD-DiT, Rotarix and Tritanrix-HepB/Hib) at that point in time; if any one of these AEs occur at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE:

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Acute disease at the time of vaccination
Description

Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infections, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axillary/tympanic measurements). The study visit should be postponed until the illness has improved. These AEs constitute contraindications to administration of the study vaccines (10Pn-PD-DiT, Rotarix and Tritanrix-HepB/Hib) at that point in time; if any one of these AEs occur at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

Data type

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2368628
DTPw-HBV/Hib is absolutely contra-indicated if the infant has experienced an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine
Description

In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, and Hib vaccines. The following adverse event constitutes an absolute contraindication to administration of the DTPw-HBV/Hib vaccine; if this adverse event occurs during the study, the investigator must decide which vaccine to give to the subject for these antigens. Contraindication(s) to the administration of the DTPw-HBV/Hib vaccine does not constitute contraindication to the administration of the pneumococcal vaccine. Children who will not receive the DTPw- HBV/Hib vaccine may still receive the study pneumococcal vaccine: the decision is left to the discretion of the investigator.

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C0012559
UMLS CUI [1,5]
C2240392
UMLS CUI [1,6]
C0199818
UMLS CUI [2,1]
C0085584
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0205156
UMLS CUI [2,4]
C1533734
UMLS CUI [2,5]
C0031237
Rotarix is contra-indicated in infants who have known or suspected immunodefiency. However, Rotarix can be given to asymptomatic HIV infected subjects.
Description

N.B. Contraindication(s) to the administration of the HRV vaccine does not constitute contraindication to the administration of the pneumococcal vaccine. Children who will not receive the HRV vaccine may still receive the study pneumococcal vaccine: the decision is left to the discretion of the investigator.

Data type

boolean

Alias
UMLS CUI [1,1]
C0597418
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0205309
UMLS CUI [1,4]
C0021051
UMLS CUI [1,5]
C1705847
UMLS CUI [1,6]
C0231221
UMLS CUI [1,7]
C0019693
UMLS CUI [2,1]
C0597418
UMLS CUI [2,2]
C0522473
UMLS CUI [2,3]
C0750491
UMLS CUI [2,4]
C0021051
UMLS CUI [2,5]
C1705847
UMLS CUI [2,6]
C0231221
UMLS CUI [2,7]
C0019693
Rotarix should not be administered to subjects with any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract.
Description

N.B. Contraindication(s) to the administration of the HRV vaccine does not constitute contraindication to the administration of the pneumococcal vaccine. Children who will not receive the HRV vaccine may still receive the study pneumococcal vaccine: the decision is left to the discretion of the investigator.

Data type

boolean

Alias
UMLS CUI [1,1]
C0597418
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C0017178
UMLS CUI [2,1]
C0597418
UMLS CUI [2,2]
C0522473
UMLS CUI [2,3]
C4023588
UMLS CUI [2,4]
C1744681
UMLS CUI [2,5]
C4072785
Tritanrix-HepB/Hib Warnings and Precautions
Description

Tritanrix-HepB/Hib Warnings and Precautions

Alias
UMLS CUI-1
C0205195
UMLS CUI-2
C0042210
UMLS CUI-3
C0012559
UMLS CUI-4
C2240392
UMLS CUI-5
C0199818
UMLS CUI-6
C1882442
UMLS CUI-7
C0871599
Body temperature following vaccination
Description

Axillary or oral temperature of >= 40°C or rectal temperature >= 40.5°C within 48 hours of vaccination, not due to another identifiable cause.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Collapse or hypotonic-hyporesponsive episode following vaccination
Description

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0344329
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
UMLS CUI [2,1]
C0549384
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0042196
Persistent crying following vaccination
Description

Persistent crying lasting >= 3 hours, occurring within 48 hours of vaccination.

Data type

boolean

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Convulsions with or without fever following vaccination
Description

Convulsions with or without fever, occurring within 3 days of vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C4048158
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0015967
UMLS CUI [1,4]
C0332282
UMLS CUI [1,5]
C0042196
UMLS CUI [2,1]
C0009952
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0042196
Rotarix vaccine warnings and precautions
Description

Rotarix vaccine warnings and precautions

Alias
UMLS CUI-1
C0597418
UMLS CUI-2
C1882442
UMLS CUI-3
C0871599
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting
Description

Administration of Rotarix postponed in case of diarrhoea/vomiting

Data type

boolean

Alias
UMLS CUI [1,1]
C0597418
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205421
UMLS CUI [1,4]
C0042963
UMLS CUI [2,1]
C0597418
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0205421
UMLS CUI [2,4]
C0011991
Vaccination administration
Description

Vaccination administration

Alias
UMLS CUI-1
C2368628
Vaccine
Description

Please fill in this repeating Itemgroup for each vaccine administered on that day. The 10Pn-PD-DiT vaccine is administered at Visits 1 (all cohorts), 2 (all cohorts except the 2+1 schedule HIV-neg. cohort), 3 (all cohorts) and 5 (all cohorts except the EPI/3+0 schedule HIV-neg. cohort). The DTPw-HBV/Hib vaccine is administered at Visits 1, 2, 3 and 8 (all cohorts). The HRV vaccine is administered at Visits 2 and 3, but only if Amendment 1 / Amendment 2 ICF has been signed before or on the day of the Visit.

Data type

integer

Alias
UMLS CUI [1]
C0042210
Vaccine administration
Description

If not administered please give the major reason and provide who took the decision. Vaccine as planned: see item "Vaccine"

Data type

text

Alias
UMLS CUI [1]
C2368628
If Replacement Vial, specify Identifier
Description

Replacement vial

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
If Wrong vial number, specify Identifier
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
Has the study vaccine been administered according to the Protocol?
Description

If no please select all following items that apply. For the HRV vaccine (if applicable), only give a comment in case of "no". The side/site route for 10Pn-PD-DiT Vaccine: right thigh i.m. The side/site route for DTPw-HBV/Hib Vaccine: left thigh i.m. The route for HRV vaccine is oral.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Vaccine Administration Side?
Description

if not according to protocol

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C2368628
Vaccine Administration Site?
Description

if not according to protocol

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2368628
Vaccine Administration Route?
Description

if not according to protocol

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2368628
Vaccine Administration Comment
Description

if administration not according to protocol

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
major reason for vaccine non-administration
Description

If SAE, please complete and submit SAE report, and specify SAE No. If AE, please complete Non-serious Adverse Event section, and specify AE No. If Other Reason, please specify

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205164
Specify SAE Number
Description

if SAE major reason for non-administration

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Specify AE Number
Description

if AE major reason for non-administration

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify other reason for non-administration
Description

e.g.: consent withdrawal, Protocol violation, …

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C3840932
UMLS CUI [1,5]
C2348235
Please select who made the decision
Description

Who made non-administration decision

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
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Similar models

Vaccine Administration, Contraindications, Precautions

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (3+1 Schedule: HIV +/+) (1)
CL Item
HIV-neg. exposed (3+1 Schedule: HIV +/-) (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3+1 Schedule: HIV -/-) (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (EPI Schedule: HIV -/-) (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (2+1 Schedule: HIV -/-) (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 5 (4)
CL Item
Visit 8 (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Vaccination Dose
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccination Dose
Code List
Vaccination Dose
CL Item
Dose 1 (1)
CL Item
Dose 2 (2)
CL Item
Dose 3 (3)
CL Item
Booster Dose of 10Pn-PD-DiT (4)
CL Item
Booster Dose of DTPw-HBV/Hib (5)
Date of administration of Vaccine
Item
Date of administration of Vaccine
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Site of temperature measurement
text
C0489453 (UMLS CUI [1])
Route
Code List
Site of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Item Group
Contraindications to vaccination
C0522473 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions
Item
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0002792 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Acute disease at the time of vaccination
Item
Acute disease at the time of vaccination
boolean
C0001314 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Contra-indication to DTPw-HBV/Hib vaccine: encephalopathy of unknown etiology following previous pertussis vaccination
Item
DTPw-HBV/Hib is absolutely contra-indicated if the infant has experienced an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine
boolean
C0522473 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0012559 (UMLS CUI [1,4])
C2240392 (UMLS CUI [1,5])
C0199818 (UMLS CUI [1,6])
C0085584 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C1533734 (UMLS CUI [2,4])
C0031237 (UMLS CUI [2,5])
Rotarix contra-indication: known or suspected immunodefiency except asymptomatic HIV
Item
Rotarix is contra-indicated in infants who have known or suspected immunodefiency. However, Rotarix can be given to asymptomatic HIV infected subjects.
boolean
C0597418 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
C0231221 (UMLS CUI [1,6])
C0019693 (UMLS CUI [1,7])
C0597418 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0021051 (UMLS CUI [2,4])
C1705847 (UMLS CUI [2,5])
C0231221 (UMLS CUI [2,6])
C0019693 (UMLS CUI [2,7])
Rotarix contra-indications: history of chronic gastrointestinal disease, uncorrected congenital malformation of the gastrointestinal tract
Item
Rotarix should not be administered to subjects with any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract.
boolean
C0597418 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0017178 (UMLS CUI [1,4])
C0597418 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C4023588 (UMLS CUI [2,3])
C1744681 (UMLS CUI [2,4])
C4072785 (UMLS CUI [2,5])
Item Group
Tritanrix-HepB/Hib Warnings and Precautions
C0205195 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
C0012559 (UMLS CUI-3)
C2240392 (UMLS CUI-4)
C0199818 (UMLS CUI-5)
C1882442 (UMLS CUI-6)
C0871599 (UMLS CUI-7)
Body temperature following vaccination
Item
Body temperature following vaccination
boolean
C0005903 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Collapse or hypotonic-hyporesponsive episode following vaccination
Item
Collapse or hypotonic-hyporesponsive episode following vaccination
boolean
C0344329 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0549384 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Persistent crying following vaccination
Item
Persistent crying following vaccination
boolean
C2721683 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Convulsions with or without fever following vaccination
Item
Convulsions with or without fever following vaccination
boolean
C4048158 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
C0009952 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Item Group
Rotarix vaccine warnings and precautions
C0597418 (UMLS CUI-1)
C1882442 (UMLS CUI-2)
C0871599 (UMLS CUI-3)
Administration of Rotarix postponed in case of diarrhoea/vomiting
Item
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting
boolean
C0597418 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,3])
C0042963 (UMLS CUI [1,4])
C0597418 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0205421 (UMLS CUI [2,3])
C0011991 (UMLS CUI [2,4])
Item Group
Vaccination administration
C2368628 (UMLS CUI-1)
Item
Vaccine
integer
C0042210 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine
CL Item
10Pn-PD-DiT vaccine (1)
CL Item
DTPw-HBV/Hib vaccine (2)
CL Item
HRV vaccine (3)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration: Infanrix Hexa or DTPa-IPV/Hib Vaccine
Code List
Vaccine administration
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
CL Item
Vaccine as planned (S)
Replacement vial
Item
If Replacement Vial, specify Identifier
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
If Wrong vial number, specify Identifier
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Vaccine administered according to the Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Vaccine Administration Side?
text
C0441987 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side
Code List
Vaccine Administration Side?
CL Item
Left (L)
CL Item
Right (R)
Item
Vaccine Administration Site?
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Site
Code List
Vaccine Administration Site?
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Vaccine Administration Route?
text
C0013153 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Site
Code List
Vaccine Administration Route?
CL Item
I.M. (M)
CL Item
S.C. (SC)
Vaccine Administration Comment
Item
Vaccine Administration Comment
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
major reason for vaccine non-administration
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
major reason for vaccine non-administration
Code List
major reason for vaccine non-administration
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
Specify SAE Number
Item
Specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify AE Number
Item
Specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
other reason for non-administration
Item
Specify other reason for non-administration
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Please select who made the decision
text
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Who made non-administration decision
Code List
Please select who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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