Clinical Trial: Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Ch
Brief 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.
Detailed Summary:
Sponsor: Beijing Minhai Biotechnology Co., Ltd
Current Primary Outcome: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL [ Time Frame: 28 days after last dose of primary vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of Subjects With Any Solicited Local and General Symptoms [ Time Frame: Within 7 days after any vaccination ]
- Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within 28 days after any vaccination ]
- Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations [ Time Frame: 28 days after last dose of primary vaccination ]
Original Secondary Outcome: Same as current
Information By: Beijing Minhai Biotechnology Co., Ltd
Dates:
Date Received: September 19, 2015
Date Started: September 2014
Date Completion: June 2016
Last Updated: September 24, 2015
Last Verified: September 2015
