ID

14901

Description

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Screening

Keywords

Versions (1)
  1. 5/5/16 5/5/16 -
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May 5, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Screening Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

English

Screening "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 forms  
Identification
Description

Identification

Alias
UMLS CUI-1
C1300638
Center number:
Description

Center number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Number of Visit
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Visit Date
Description

VisitDate

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0545082
Informed Consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Has the Patient had any serious adverse Event since the end of the primatry study and before the beginning of this Booster vaccination
Description

Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
adverse event type
Description

if yes, please specify. Check SAE forms have been submitted to GSK biologicals

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0332307
Eligibility
Description

Eligibility

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria
Description

If no, tick all the boxes, corresponding to violations

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Eligibility: Inclusion Criteria
Description

Eligibility: Inclusion Criteria

Male or female between, and including, 12-18 months of age at the time of vaccination.
Description

Male or female between, and including, 12-18 months of age at the time of vaccination.

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0001779
Subjects who previously participated in the study 1 OPN-PD-DIT-001 and received at least one dose of pneumococcal conjugate vaccine during the primary study.
Description

Subjects who previously participated in the study 1 OPN-PD-DIT-001 and received at least one dose of pneumococcal conjugate vaccine during the primary study.

Data type

boolean

Alias
UMLS CUI [1]
C0087111
Subjects for whom 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 visit).
Description

Subjects for whom 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 visit).

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Written informed consent obtained from the parent or guardian of the subject.
Description

Written informed consent obtained from the parent or guardian of the subject.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Description

Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Eligibility: Exclusion Criteria
Description

Eligibility: Exclusion Criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period (active phase and extended safety follow-up).
Description

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period (active phase and extended safety follow-up).

Data type

boolean

Alias
UMLS CUI [1]
C0087111
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the dose of vaccine(s). (For corticosteroids, this will mean prednisone, or equivalent, 2 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Description

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the dose of vaccine(s). (For corticosteroids, this will mean prednisone, or equivalent, 2 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

Data type

boolean

Alias
UMLS CUI [1]
C0001617
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the dose of vaccine(s) up to Visit 2.
Description

Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the dose of vaccine(s) up to Visit 2.

Data type

boolean

Alias
UMLS CUI [1]
C0042196
Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study.
Description

Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0042196
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Description

Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).

Data type

boolean

Alias
UMLS CUI [1]
C0021051
A family history of congenital or hereditary immunodeficiency
Description

A family history of congenital or hereditary immunodeficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0439660
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0020517
Major congenital defects or serious chronic illness.
Description

Major congenital defects or serious chronic illness.

Data type

boolean

Alias
UMLS CUI [1]
C0009488
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Description

History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.

Data type

boolean

Alias
UMLS CUI [1]
C0036572
Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
Description

Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Anaphylactic reaction following the administration ofvaccine(s).
Description

Anaphylactic reaction following the administration ofvaccine(s).

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
Acute disease at the time of enrolment. (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 with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C I rectal temperature <38.0°C).
Description

Acute disease at the time of enrolment. (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 with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C I rectal temperature <38.0°C).

Data type

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0221423
UMLS CUI [2,1]
C1547226
UMLS CUI [2,2]
C0221423
Febrile illness defined as oral, axillary or tympanic temperature 37.5°C, rectal temperature 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Description

Febrile illness defined as oral, axillary or tympanic temperature 237.5°C, rectal temperature 238.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Data type

text

Alias
UMLS CUI [1]
C0015967
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Similar models

Screening "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Identification
C1300638 (UMLS CUI-1)
Center number
Item
Center number:
integer
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Item
Number of Visit
integer
C1549755 (UMLS CUI [1])
Visit Number
Code List
Number of Visit
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
VisitDate
Item
Visit Date
date
C0011008 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Informed consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (m)
CL Item
Female (f)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse Events
Item
Has the Patient had any serious adverse Event since the end of the primatry study and before the beginning of this Booster vaccination
boolean
C0877248 (UMLS CUI [1])
adverse event type
Item
adverse event type
text
C0877248 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Eligibility
C0013893 (UMLS CUI-1)
perfect eligibility
Item
Did the subject meet all the entry criteria
boolean
C0013893 (UMLS CUI [1])
Male or female between, and including, 12-18 months of age at the time of vaccination.
Item
Male or female between, and including, 12-18 months of age at the time of vaccination.
boolean
C0042196 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Subjects who previously participated in the study 1 OPN-PD-DIT-001 and received at least one dose of pneumococcal conjugate vaccine during the primary study.
Item
Subjects who previously participated in the study 1 OPN-PD-DIT-001 and received at least one dose of pneumococcal conjugate vaccine during the primary study.
boolean
C0087111 (UMLS CUI [1])
Subjects for whom 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 visit).
Item
Subjects for whom 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 visit).
boolean
C1321605 (UMLS CUI [1])
Written informed consent obtained from the parent or guardian of the subject.
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period (active phase and extended safety follow-up).
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period (active phase and extended safety follow-up).
boolean
C0087111 (UMLS CUI [1])
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the dose of vaccine(s). (For corticosteroids, this will mean prednisone, or equivalent, 2 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the dose of vaccine(s). (For corticosteroids, this will mean prednisone, or equivalent, 2 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0001617 (UMLS CUI [1])
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the dose of vaccine(s) up to Visit 2.
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the dose of vaccine(s) up to Visit 2.
boolean
C0042196 (UMLS CUI [1])
Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study.
Item
Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study.
boolean
C0040223 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1])
A family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency
boolean
C0021051 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0020517 (UMLS CUI [1])
Major congenital defects or serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
C0009488 (UMLS CUI [1])
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Item
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
boolean
C0036572 (UMLS CUI [1])
Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Anaphylactic reaction following the administration ofvaccine(s).
Item
Anaphylactic reaction following the administration ofvaccine(s).
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Acute disease at the time of enrolment. (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 with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C I rectal temperature <38.0°C).
Item
Acute disease at the time of enrolment. (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 with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C I rectal temperature <38.0°C).
boolean
C0205082 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C1547226 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
Febrile illness defined as oral, axillary or tympanic temperature 237.5°C, rectal temperature 238.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Item
Febrile illness defined as oral, axillary or tympanic temperature 37.5°C, rectal temperature 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
text
C0015967 (UMLS CUI [1])
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