Clinical Trial: A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children

Brief Summary: Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.

Detailed Summary: Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized, positive-controlled, non-inferiority phase III clinical trial is planned to conduct in healthy infants and children in China.
Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Current Primary Outcome:

  • incidence of solicited adverse reactions [ Time Frame: 0-7 days after each dose ]
  • proportion of vaccinees with anti-polyribosylribitol phosphate (PRP) concentrations ≥1.0μg/ml [ Time Frame: 28 days after full course of vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • incidence of unsolicited adverse reactions [ Time Frame: 0-28 days after each dose ]
  • incidence of serious adverse event (SAE) during the whole study period [ Time Frame: 0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y ]
  • proportion of vaccinees with anti-polyribosylribitol phosphate (PRP) concentrations ≥0.15μg/ml [ Time Frame: 28 days after full course of vaccination ]
  • the anti-PRP geometric mean concentrations (GMCs) [ Time Frame: 28 days after full course of vaccination ]
  • the anti-PRP geometric mean fold increase (GMFI) [ Time Frame: 28 days after full course of vaccination ]


Original Secondary Outcome: Same as current

Information By: Jiangsu Province Centers for Disease Control and Prevention

Dates:
Date Received: February 24, 2016
Date Started: September 2013
Date Completion:
Last Updated: February 24, 2016
Last Verified: February 2016