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)
- 5/5/16 5/5/16 -
Uploaded on
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
Screening "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Description
Administrative
Alias
- UMLS CUI-1
- C1320722
Description
Visit Number
Data type
integer
Alias
- UMLS CUI [1]
- C1549755
Description
VisitDate
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0545082
Description
Informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Informed Consent Date
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Events
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
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
Description
Eligibility
Alias
- UMLS CUI-1
- C0013893
Description
Eligibility: Inclusion Criteria
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
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
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
Description
Written informed consent obtained from the parent or guardian of the subject.
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
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
Description
Eligibility: Exclusion Criteria
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
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
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
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
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
Description
A family history of congenital or hereditary immunodeficiency
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021051
- UMLS CUI [1,2]
- C0439660
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
Description
Major congenital defects or serious chronic illness.
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
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
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
Description
Anaphylactic reaction following the administration ofvaccine(s).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0042210
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
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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Screening "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
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