NCT01090453

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

Conditions

• Tetanus
• Hepatitis B
• Haemophilus Influenzae Type b
• Poliomyelitis
• Acellular Pertussis
• Diphtheria
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	GSK2202083A vaccine	3 doses given at 2, 4 and 12 months of age
BIOLOGICAL	Prevenar 13®	3 co-administered doses
BIOLOGICAL	Infanrix hexa™	3 doses given at 2, 4 and 12 months of age
BIOLOGICAL	Menjugate®	3 co-administered doses
BIOLOGICAL	Rotarix™	Oral, two doses

Timeline

• Start date: 2010-05-17
• Primary completion: 2011-10-11
• Completion: 2011-10-11
• First posted: 2010-03-22
• Last updated: 2018-08-20
• Results posted: 2014-08-15

Locations

34 sites across 3 countries: Canada, France, Germany