The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
61
1 dose administered intramuscularly
1 dose administered intramuscularly
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Berchtesgaden, Bavaria, Germany
GSK Investigational Site
Braunatal, Hesse, Germany
GSK Investigational Site
Berlin, Germany
Occurrence of each grade 3 solicited adverse event with relationship to vaccination
Time frame: Within 7 days (Day 0-Day 6) after vaccination
Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
Time frame: Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse events with relationship to vaccination
Time frame: During the entire study (from Month 0 up to Month 1)
Occurrence of each solicited adverse event
Time frame: Within 7 days (Day 0-Day 6) after vaccination
Occurrence of each unsolicited adverse event
Time frame: Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse event
Time frame: During the entire study (from Month 0 up to Month 1)
Evaluation of the immune responses to the components of the 2830930A vaccine
Time frame: One month post-vaccination
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