NCT02096263

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 585 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Infanrix hexa	3 doses administered intramuscularly in the right thigh.
BIOLOGICAL	Pediarix	3 doses administered intramuscularly in the right thigh
BIOLOGICAL	ActHIB	4 doses administered intramuscularly in the upper left thigh
BIOLOGICAL	Pentacel	4 doses administered intramuscularly in the right thigh
BIOLOGICAL	Engerix-B	2 or 3 doses administered intramuscularly in the upper left thigh
BIOLOGICAL	Infanrix	1 dose administered intramuscularly in the right thigh
BIOLOGICAL	Hiberix	1 dose administered intramuscularly in the left thigh
BIOLOGICAL	Prevnar13	3 doses administered intramuscularly in the lower left thigh
BIOLOGICAL	Rotarix	2 doses administered orally

Timeline

• Start date: 2014-04-16
• Primary completion: 2015-02-06
• Completion: 2015-11-13
• First posted: 2014-03-26
• Last updated: 2019-11-27
• Results posted: 2018-08-01

Locations

43 sites across 1 country: United States