Trials / Completed
CompletedNCT00985751
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 257 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 23 Months
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal vaccine GSK2189242A (formulation 1) | Three doses will be administered intramuscularly, at Month 0, 2 and 6. |
| BIOLOGICAL | Pneumococcal vaccine GSK2189242A (formulation 2) | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| BIOLOGICAL | Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| BIOLOGICAL | Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4) | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| BIOLOGICAL | Pneumococcal vaccine GSK1024850A | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
Timeline
- Start date
- 2009-11-24
- Primary completion
- 2010-10-12
- Completion
- 2011-03-02
- First posted
- 2009-09-28
- Last updated
- 2020-11-05
- Results posted
- 2017-10-06
Locations
10 sites across 1 country: Czechia
Source: ClinicalTrials.gov record NCT00985751. Inclusion in this directory is not an endorsement.