The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site

Study Overview
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Brief Summary
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The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.

Detailed Description
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A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.

Official Title
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Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site

Conditions
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Healthy

Intervention / Treatment
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* Biological: Inoculation in upper arm deltoid
* Biological: Inoculation in vastus lateralis muscle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants were under 1 years old, and were in good healthy participants were full-time pregnancy and birth weight were more than 2.5 kg Exclusion Criteria: current infectious fever or acute disease a history of hypersensitivity to study vaccine components especially tetanus toxoid a history of allergy, autoimmune, convulsions, seizures heredity disease a history of Hib vaccination or Hib disease a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inoculation in upper arm deltoid<br>Inoculation of Hib vaccine of two brands in upper arm deltoid | Biological: Inoculation in upper arm deltoid<br>* Inoculation of Hib vaccine of two brands in upper arm deltoid<br>Biological: Inoculation in vastus lateralis muscle<br>* Inoculation of Hib vaccine of two brands in vastus lateralis muscle<br>|
| Experimental: Inoculation in vastus lateralis muscle<br>Inoculation of Hib vaccine of two brands in vastus lateralis muscle | Biological: Inoculation in upper arm deltoid<br>* Inoculation of Hib vaccine of two brands in upper arm deltoid<br>Biological: Inoculation in vastus lateralis muscle<br>* Inoculation of Hib vaccine of two brands in vastus lateralis muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titre of Haemophilus influenzae type b vaccine in different injection site |  | one year |