ID
14901
Beschreibung
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
Stichworte
Versionen (1)
- 05.05.16 05.05.16 -
Hochgeladen am
5. Mai 2016
DOI
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Lizenz
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
Beschreibung
Administrative
Alias
- UMLS CUI-1
- C1320722
Beschreibung
Visit Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1549755
Beschreibung
VisitDate
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0545082
Beschreibung
Informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Informed Consent Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985782
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse Events
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
if yes, please specify. Check SAE forms have been submitted to GSK biologicals
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0332307
Beschreibung
Eligibility
Alias
- UMLS CUI-1
- C0013893
Beschreibung
Eligibility: Inclusion Criteria
Beschreibung
Male or female between, and including, 12-18 months of age at the time of vaccination.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0001779
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0087111
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Written informed consent obtained from the parent or guardian of the subject.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018759
Beschreibung
Eligibility: Exclusion Criteria
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0087111
Beschreibung
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.)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001617
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042196
Beschreibung
Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0042196
Beschreibung
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021051
Beschreibung
A family history of congenital or hereditary immunodeficiency
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021051
- UMLS CUI [1,2]
- C0439660
Beschreibung
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0020517
Beschreibung
Major congenital defects or serious chronic illness.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0036572
Beschreibung
Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Beschreibung
Anaphylactic reaction following the administration ofvaccine(s).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0042210
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205082
- UMLS CUI [1,2]
- C0221423
- UMLS CUI [2,1]
- C1547226
- UMLS CUI [2,2]
- C0221423
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0015967
Ähnliche Modelle
Screening "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2])
C0042210 (UMLS CUI [1,2])
C0221423 (UMLS CUI [1,2])
C1547226 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])