drugset / Trial / NCT02560272

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

NCT02560272

Phase 3 Unknown 1560 enrolled Beijing Minhai Biotechnology Co., Ltd
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2014-09
Primary completion
2015-12
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator ActHIB Vaccine 0.5 ml Intramuscular
Subject Minhai-HIB Vaccine 0.5 ml Intramuscular