Status:
COMPLETED
Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-valent Pneumococcal Polysaccharide Vaccine (Pneumo 23)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prophylaxis Pneumococcal Vaccine
Eligibility:
All Genders
31-57 years
Phase:
PHASE3
Brief Summary
Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valen...
Detailed Description
Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK Biologicals' Havri...
Eligibility Criteria
Inclusion
- Inclusion criteria: Male or female who participated in Undeca-Pn-010 study, were part of the blood subset and received 4 doses of GSK Biologicals' 11Pn-PD vaccine, or Havrix vaccine. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010)
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00169507
Start Date
March 1 2005
End Date
April 1 2005
Last Update
May 30 2017
Active Locations (4)
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1
GSK Investigational Site
Dubnica nad Váhom, Slovakia, 018 41
2
GSK Investigational Site
Nová Dubnica, Slovakia, 018 51
3
GSK Investigational Site
Považská Bystrica, Slovakia, 017 01
4
GSK Investigational Site
Púchov, Slovakia, 020 01