NCT01761136

The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site

Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Beijing Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.

Detailed description

A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Inoculation in upper arm deltoid	Inoculation of Hib vaccine of two brands in upper arm deltoid
BIOLOGICAL	Inoculation in vastus lateralis muscle	Inoculation of Hib vaccine of two brands in vastus lateralis muscle

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2013-01-04
• Last updated: 2013-03-28

Locations

5 sites across 1 country: China