NCT01262872

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Years in The Gambia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,320 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 56 Days – 4 Years
• Healthy volunteers: Accepted

Summary

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Detailed description

There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2 (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist in a safety evaluation of the GSK Biologicals' pneumococcal vaccine 2189242A (GSK 2189242A or 10PP vaccine). Before evaluating the two formulations of the 10PP vaccine in infants (Cohort 2), safety and reactogenicity of the highest dose formulation of this vaccine will be evaluated in children (Cohort 1). Prevnar 13™ will be used as a control. In the second step of the study, Step 2, two investigational formulations of the 10PP vaccine will be tested in infants (Cohort 2) as regards immunogenicity, reactogenicity and safety. Both formulations of the 10PP vaccine will be evaluated according to the Expanded Programme on Immunization (EPI) schedule i.e. a 2, 3, 4 months vaccination schedule, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators. The higher dose (HD) formulation of the 10PP vaccine will be also evaluated according to the 2, 4, 9 months vaccination schedule using licensed Synflorix™ vaccine as comparator. The study in infants will also assess the immune responses to routine vaccines when co-administered with the candidate pneumococcal vaccine, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK 2189242A (LD formulation 1)	Intramuscular injection
BIOLOGICAL	Pneumococcal vaccine GSK 2189242A (HD formulation 2)	Intramuscular injection
BIOLOGICAL	Synflorix™	Intramuscular injection
BIOLOGICAL	Prevnar13™	Intramuscular injection
BIOLOGICAL	Tritanrix™-HepB/Hib	Intramuscular injection
BIOLOGICAL	Polio Sabin™	Orally
BIOLOGICAL	M-Vac™	Intramuscular injection
BIOLOGICAL	Stamaril™	Intramuscular injection

Timeline

• Start date: 2011-02-09
• Primary completion: 2013-03-18
• Completion: 2013-03-18
• First posted: 2010-12-17
• Last updated: 2019-06-19
• Results posted: 2014-04-21

Locations

1 site across 1 country: The Gambia