At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.
In Brief
A Phase 2 clinical trial evaluating Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2), and 3 other interventions for Infections, Streptococcal. Completed, enrolled 257 participants across 10 sites.
Detailed Summary
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \>40.0°C).
Study Details
Timeline
Interventions
Three doses will be administered intramuscularly, at Month 0, 2 and 6.
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Three doses will be administered intramuscularly, at Month 0, 2 and 6