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

Phase 3

Completed

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 Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Vaccine (Walvax Biotechnology Co., LTD.)	Hib conjugate vaccine	Hib conjugate vaccine
Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)	Hib conjugate vaccine	Hib conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Solicited Adverse Reactions	0-7 days after each dose	Number of Participants with Solicited Adverse Reactions
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml	28 days after full course of vaccination

Secondary Outcome Measures

Name	Time	Method
the Anti-PRP Geometric Mean Concentrations (GMCs)	28 days after full course of vaccination
the Anti-PRP Geometric Mean Fold Increase (GMFI)	28 days after full course of vaccination
Incidence of Unsolicited Adverse Reactions	0-28 days after each dose
Incidence of Serious Adverse Event (SAE) During the Whole Study Period	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	28 days after full course of vaccination