Last updated: 03/05/2020 20:50:10

A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals' meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age

GSK study ID
108661
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals' meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age
Trial description: A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals' meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2009-12-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Meningococcal Vaccines
Product
GSK134612A, SB208144
Collaborators
Not applicable
Study date(s)
February 2009 to May 2009
Type
Interventional
Phase
2

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Espoo, Finland, 02100
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00100
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00930
Status
Study Complete
Location
GSK Investigational Site
Jarvenpaa, Finland, 04400
Status
Study Complete
Location
GSK Investigational Site
Lahti, Finland, 15140
Status
Study Complete
Location
GSK Investigational Site
Oulu, Finland, 90220
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
No longer a GSK study
Actual primary completion date
2009-12-05
Actual study completion date
2009-12-05

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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