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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Haemophilus Influenza

Intervention / Treatment
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* Biological: Hib conjugate vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)<br>Hib conjugate vaccine | Biological: Hib conjugate vaccine<br>* 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<br>|
| Active Comparator: Vaccine (Walvax Biotechnology Co., LTD.)<br>Hib conjugate vaccine | Biological: Hib conjugate vaccine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |