A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
Condition: Haemophilus Influenza
MeSH terms: Influenza, Human; Haemophilus Infections
Intervention: Hib conjugate vaccine
Intervention description: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1992.0
Sex: All
Minimum age: 3 Months
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group

          -  Without vaccination history of Hib conjugate vaccine

          -  One of his/her guardians is able to understand and sign the informed consent

          -  Subjects' guardian can and will comply with the requirements of the protocol

          -  Subjects with temperature <=37.0°C on axillary setting

        Exclusion Criteria:

          -  Subject who has a medical or family history of any of the following: allergic history,
             seizure, epilepsy, brain or mental disease

          -  Subject who is allergic to any ingredient of the vaccines

          -  Subject with damaged or low immune function which has already been known

          -  Subject who had a Hib disease medical history

          -  Subject with acute febrile illness or infectious disease

          -  Major congenital defects, developmental disorders or serious chronic illness

          -  Thrombocytopenia, blood coagulation disorder or bleeding difficulties with
             intramuscular injection

          -  Subject who has serious allergic history

          -  Subject with other medical history not suitable for vaccination such as difficulty for
             blood collection

          -  Any prior administration of immunodepressant or corticosteroids in last 6 months

          -  Any prior administration of blood products in last 3 months

          -  Any prior administration of other research medicine/vaccine in last 30 days

          -  Any prior administration of any attenuated live vaccine in last 14 days

          -  Any prior administration of subunit or inactivated vaccines in last 7 days, such as
             pneumococcal vaccine

          -  Any medical, psychological, social or other condition judged by investigator, that may
             interfere subject's compliance with the protocol or his/her guardian's signature on
             informed consent