Last updated: 11/03/2018 00:29:52
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)
GSK study ID
104083
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase III multicentric open study to evaluate immunological memory induced by 3-dose primary vaccination followed by booster dose of GSK Biologicals' 11-valent conjugate pneumococcal vaccine compared to unprimed subjects by giving 1 dose of Aventis Pasteur's Pneumo 23
Trial description: 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-valent pneumococcal vaccine in Undeca-Pn-010 study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Pneumococcal (vaccine)
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prophylaxis pneumococcal vaccine
Product
SB347414
Collaborators
Not applicable
Study date(s)
March 2005 to April 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
31 - 57 months
Accepts healthy volunteers
Yes
- 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.
- 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)
Inclusion and exclusion criteria
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)
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-18-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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