NCT02560272

Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried

A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,560 (estimated)
• Sponsor: Beijing Minhai Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 2 Months – 5 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.

Conditions

• Haemophilus Influenzae Type b Infections

Interventions

Type	Name	Description
BIOLOGICAL	Minhai-HIB	0.5ml, intramuscular
BIOLOGICAL	Act-HIB®	0.5ml, intramuscular

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2015-09-25
• Last updated: 2015-09-25

Locations

1 site across 1 country: China