The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.
This amendment was due to * The addition of secondary endpoints for safety. The collection of data related to these secondary safety endpoints was already planned and the corresponding statistical analyses were described in the statistical section. * The addition of an exclusion criterion regarding the administration of immunoglobulins and blood products. It is already included in the elimination criteria section. It impacts only immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
157
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
GSK Investigational Site
Ghent, Belgium
Occurrence of any vaccine related and grade 3 solicited local and general adverse events
Time frame: During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
Time frame: During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
Time frame: From Visit 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
Time frame: During a 7-day follow up period after each vaccine dose
Occurrence of any solicited local and general adverse events
Time frame: During a 7-day follow up period after each vaccine dose.
Occurrence of any unsolicited adverse events
Time frame: During a 31-day follow up period after each vaccine dose
Occurrence of any haematological, biochemical, or urinary abnormalities
Time frame: At 1 and 7 days after each vaccine dose
Anti-pneumococcal and anti-NTHi candidate vaccine antigens
Time frame: At Days 0, 30 and 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.