ID

32061

Description

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form contains Contraindications to subsequent vaccination. Depending on the subset, the relevant/applicable items need to be checked prior to any vaccination during the study (Visits 1 - 5). Visit 1 -> Timing: Day 0, Age: 6 weeks +/- 1 week; OPV for all subjects Visit 2 -> Timing: Day 30, Age: 10 weeks +/- 1 week; OPV for subset of HRV/HRV-PI alone Visit 3 -> Timing: Day 45, Age: 12 weeks +/- 1 week; OPV for subset of HRV/HRV-PI + OPV, HRV for all subjects Visit 4 -> Timing: Day 60, Age: 14 weeks +/- 1 week; OPV for subset of HRV/HRV-PI alone Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week; OPV for subset of HRV/HRV-PI + OPV, HRV for all subjects

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Keywords

Versions (2)
  1. 10/16/18 10/16/18 - Sarah Riepenhausen
  2. 10/16/18 10/16/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

English

Contraindications to subsequent vaccination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Number
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Contraindications to subsequent Vaccination: GSK Biologicals' HRV vaccine or its placebo
Description

Contraindications to subsequent Vaccination: GSK Biologicals' HRV vaccine or its placebo

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0597418
Hypersensitivity reaction due to the vaccine [A]
Description

This adverse event (AEs) constitutes an absolute contraindication to further administration of HRV vaccine or placebo; if this AE occurs during the study, the subject must not receive additional doses of vaccine 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]
C0597418
IS [B]
Description

This adverse event (AEs) constitutes an absolute contraindication to further administration of HRV vaccine or placebo; if this AE occurs during the study, the subject must not receive additional doses of vaccine 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]
C0021933
Axillary temperature >= 37.5 °C, rectal temperature >= 38.0 °C [C]
Description

This AE constitutes a contraindication to administration of HRV vaccine or placebo at that point in time; if this AE occurs 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]
C1531924
UMLS CUI [2]
C0489749
GE within 7 days preceding the study vaccine administration. [D]
Description

This AE constitutes a contraindication to administration of HRV vaccine or placebo at that point in time; if this AE occurs 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]
C0017160
Contraindications to subsequent Vaccination: GSK Biologicals’ OPV
Description

Contraindications to subsequent Vaccination: GSK Biologicals’ OPV

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0032375
Known systemic hypersensitivity to neomycin or to any other component of the vaccine. Contact dermatitis to neomycin is not a contraindication. [E]
Description

The following adverse event associated with OPV immunisation constitutes an absolute contraindication to further administration of OPV vaccine; if this adverse event occurs during the study, the subject must be withdrawn and must be followed until resolution of the event as with any adverse event:

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0027603
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0027603
UMLS CUI [3,3]
C0011616
Subjects suffering from primary and secondary immunodeficiencies. However, symptomatic and asymptomatic infection with human immunodeficiency virus does not contraindicate immunisation with OPV. [F]
Description

The following adverse event associated with OPV immunisation constitutes an absolute contraindication to further administration of OPV vaccine; if this adverse event occurs during the study, the subject must be withdrawn and must be followed until resolution of the event as with any adverse event:

Data type

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0019693
As with other vaccines, the administration of OPV should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhoea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunisation. [G]
Description

Precaution

Data type

boolean

Alias
UMLS CUI [1,1]
C0743842
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0011991
UMLS CUI [3,1]
C0042963
UMLS CUI [3,2]
C0205322
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Similar models

Contraindications to subsequent vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Contraindications to subsequent Vaccination: GSK Biologicals' HRV vaccine or its placebo
C0522473 (UMLS CUI-1)
C0597418 (UMLS CUI-2)
Hypersensitivity to vaccine
Item
Hypersensitivity reaction due to the vaccine [A]
boolean
C0020517 (UMLS CUI [1,1])
C0597418 (UMLS CUI [1,2])
IS
Item
IS [B]
boolean
C0021933 (UMLS CUI [1])
Axillary temperature >= 37.5 °C, rectal temperature >= 38.0 °C
Item
Axillary temperature >= 37.5 °C, rectal temperature >= 38.0 °C [C]
boolean
C1531924 (UMLS CUI [1])
C0489749 (UMLS CUI [2])
GE < 7 days before vaccine administration
Item
GE within 7 days preceding the study vaccine administration. [D]
boolean
C0017160 (UMLS CUI [1])
Item Group
Contraindications to subsequent Vaccination: GSK Biologicals’ OPV
C0522473 (UMLS CUI-1)
C0032375 (UMLS CUI-2)
hypersensitvity to neomycin or other vaccine component, except Neomycin contact dermatitis
Item
Known systemic hypersensitivity to neomycin or to any other component of the vaccine. Contact dermatitis to neomycin is not a contraindication. [E]
boolean
C0020517 (UMLS CUI [1,1])
C0027603 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C0027603 (UMLS CUI [3,2])
C0011616 (UMLS CUI [3,3])
primary or secondary immunodeficiencies except infection with HIV
Item
Subjects suffering from primary and secondary immunodeficiencies. However, symptomatic and asymptomatic infection with human immunodeficiency virus does not contraindicate immunisation with OPV. [F]
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
C0332300 (UMLS CUI [3,1])
C0019693 (UMLS CUI [3,2])
acute severe febrile illness, persistent diarrhoea, vomiting
Item
As with other vaccines, the administration of OPV should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhoea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunisation. [G]
boolean
C0743842 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0011991 (UMLS CUI [2])
C0042963 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
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