Last updated: 11/03/2018 09:17:11
Safety and immune response study of an investigational pneumococcal vaccine.
GSK study ID
106962
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open, phase I/II study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' 11PCV vaccine given as a 2-dose vaccination in adults aged 18-40 years old.
Trial description: The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Vaccine: pneumococcal vaccine
Enrollment:
10
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prophylactic pneumococcal diseases
Product
GSK324332A
Collaborators
Not applicable
Study date(s)
June 2006 to October 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- healthy male or female between 18 and 40 years of age
- 23-valent pneumococcal polysaccharide vaccine naive adults.
- Previous vaccination against Streptococcus pneumoniae.
- History of pneumonia within 3 years prior to the first vaccination
Inclusion and exclusion criteria
Inclusion criteria:
- healthy male or female between 18 and 40 years of age
- 23-valent pneumococcal polysaccharide vaccine naive adults.
Exclusion criteria:
- Previous vaccination against Streptococcus pneumoniae.
- History of pneumonia within 3 years prior to the first vaccination
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
- Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
- History of administration of an experimental/licensed vaccine containing similar adjuvants.
- History of chronic alcohol consumption and/or drug abuse.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
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
2006-06-10
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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