Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age

Conditions
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Haemophilus Influenzae Type b Infections

Intervention / Treatment
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* Biological: Minhai-HIB
* Biological: Act-HIB®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy permanent residence 2 months to 5 years old. Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. Axillary temperature ≤37.0 ℃. Exclusion Criteria: History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine. Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. Receipt of blood or blood-derived products in the 3 months preceding vaccination Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. Receipt of any live virus vaccine in the 15 days preceding vaccination. Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. Thrombocytopenia. History of treatment for thyroid gland disease. Functional or anatomic asplenia. History of eclampsia, epilepsy, encephalopathy and mental disease or family disease. Any condition that, in the judgment of investigator, may affect trial assessment.

Ages Eligible for Study
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Minimum Age: 2 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minhai-HIB<br>Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. | Biological: Minhai-HIB<br>* 0.5ml, intramuscular<br>|
| Active Comparator: Act-HIB®<br>Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. | Biological: Act-HIB®<br>* 0.5ml, intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 days after last dose of primary vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any Solicited Local and General Symptoms |  | Within 7 days after any vaccination | 
| Number of Subjects With Any Unsolicited Adverse Events (AEs) |  | Within 28 days after any vaccination | 
| Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations |  | 28 days after last dose of primary vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, haemophilus influenzae type b