ID

33074

Beschreibung

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Stichworte

Versionen (2)
  1. 22.11.18 22.11.18 -
  2. 26.11.18 26.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

26. November 2018

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative data
Beschreibung

Administrative data

Visit Number
Beschreibung

Visit Number

Datentyp

text

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Eligibility Question
Beschreibung

Eligibility Question

Did the subject meet all the entry criteria?
Beschreibung

Did the subject meet all the entry criteria?

Datentyp

boolean

If No, tick all boxes corresponding to violations of any exclusion/inclusion criteria
Beschreibung

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below

Datentyp

text

Inclusion Criteria
Beschreibung

Inclusion Criteria

Tick the boxes corresponding to any of the inclusion criteria the subject failed
Beschreibung

Tick the boxes corresponding to any of the inclusion criteria the subject failed

Datentyp

text

Exclusion Criteria
Beschreibung

Exclusion Criteria

Record if any of the exclusion criteria disqualified the subject from entry
Beschreibung

tick Yes, if disqualified, tick No, if not disqualified

Datentyp

text

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Beschreibung

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Datentyp

boolean

Chronic administration (more than 14 days) of immunodepressants or other immune-modifying drugs within six months prior to the first vaccine dose
Beschreibung

For corticosteroids this will mean prednisone, or equivalet, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed

Datentyp

boolean

Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
Beschreibung

Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)

Datentyp

boolean

Previous vaccination against measles, mumps, rubella and/or varicella
Beschreibung

Previous vaccination against measles, mumps, rubella and/or varicella

Datentyp

boolean

History of measles, mumps, rubella and/or varicella/zoster diseases
Beschreibung

History of measles, mumps, rubella and/or varicella/zoster diseases

Datentyp

boolean

Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
Beschreibung

Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial

Datentyp

boolean

Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
Beschreibung

Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection

Datentyp

boolean

A family history of congenital or hereditary immunodeficiency
Beschreibung

A family history of congenital or hereditary immunodeficiency

Datentyp

boolean

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Beschreibung

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Datentyp

boolean

Major congenital defects or serious chronic illness
Beschreibung

Major congenital defects or serious chronic illness

Datentyp

boolean

History of any neurologic disorders or seizures
Beschreibung

History of any neurologic disorders or seizures

Datentyp

boolean

Residence in the same household as high-risk persons
Beschreibung

high-risk persons: new-born infants (0-4 weeks of age); pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox; persons with known immunodeficiency

Datentyp

boolean

Acute disease at the time of enrolment
Beschreibung

The presence of a moderate or severe illness with or without fever. All vaccines cn be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C/ rectal temperature <38°C.

Datentyp

boolean

Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
Beschreibung

Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination

Datentyp

boolean

Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
Beschreibung

Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period

Datentyp

boolean

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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Eligibility Question
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
If No, tick all boxes corresponding to violations of any exclusion/inclusion criteria.
Item
If No, tick all boxes corresponding to violations of any exclusion/inclusion criteria
text
Item Group
Inclusion Criteria
Item
Tick the boxes corresponding to any of the inclusion criteria the subject failed
text
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Code List
Tick the boxes corresponding to any of the inclusion criteria the subject failed
CL Item
Subject who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study (1)
CL Item
Male or female subject between 11 and 21 months of age at the time of the first vaccination (2)
CL Item
Written informed consent obtained from the parent or guardian of the subject (3)
CL Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study (4)
Item Group
Exclusion Criteria
Record if any of the exclusion criteria disqualified the subject from entry
Item
Record if any of the exclusion criteria disqualified the subject from entry
text
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
Chronic administration (more than 14 days) of immunodepressants or other immune-modifying drugs within six months prior to the first vaccine dose
Item
Chronic administration (more than 14 days) of immunodepressants or other immune-modifying drugs within six months prior to the first vaccine dose
boolean
Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
Item
Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
boolean
Previous vaccination against measles, mumps, rubella and/or varicella
Item
Previous vaccination against measles, mumps, rubella and/or varicella
boolean
History of measles, mumps, rubella and/or varicella/zoster diseases
Item
History of measles, mumps, rubella and/or varicella/zoster diseases
boolean
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
Item
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
boolean
A family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency
boolean
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
boolean
Major congenital defects or serious chronic illness
Item
Major congenital defects or serious chronic illness
boolean
History of any neurologic disorders or seizures
Item
History of any neurologic disorders or seizures
boolean
Residence in the same household as high-risk persons
Item
Residence in the same household as high-risk persons
boolean
Acute disease at the time of enrolment
Item
Acute disease at the time of enrolment
boolean
Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
Item
Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
boolean
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
Item
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
boolean
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