ID
15004
Descrizione
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: EXTENDED SAFETY FOLLOW-UP CONTACT
Keywords
versioni (2)
- 09/05/16 09/05/16 -
- 11/05/16 11/05/16 -
Caricato su
11 maggio 2016
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0
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Extended safety follow-up contact Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Extended safety follow-up contact "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Descrizione
Study Conclusion Extended Safety Follow-Up Contact
Descrizione
Contract after active Phase
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0332522
Descrizione
Date of last contact
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Descrizione
If yes: GlaxoSmithKline might contact you for further investigation
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0949266
Descrizione
Reason for no successive Contract
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0332522
Descrizione
If yes,please complete the complete Serious Adverse Event (SAE) report.
Tipo di dati
text
Alias
- UMLS CUI [1]
- C1519255
Descrizione
Meningitis
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0025289
Descrizione
Investigator's Signature
Alias
- UMLS CUI-1
- C1519316
- UMLS CUI-2
- C2826892
Similar models
Extended safety follow-up contact "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,2])
C2826892 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])