Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

Study Overview
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Brief Summary
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This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Official Title
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A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart

Conditions
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Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: Haemophilus influenzae type b vaccine
* Biological: Commercial Haemophilus influenzae type b vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants of either sex, aged 2 - 4 months In good health as determined by: medical history physical examination clinical judgment of the investigator; Available for all visits scheduled in the study and able to comply with all study regulations For whom written informed consent has been obtained from at least one parent or legal guardian Exclusion Criteria: Parent or legal guardian is unwilling or unable to give written informed consent to participate in study Infants who have received any other Haemophilus influenzae type b immunization dose before Infants who presented a previous disease potentially related to Haemophilus influenzae type b Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease Premature (before 37th week of gestation) or birth weight less than 2500 g History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder Subjects with a clinically significant genetic anomaly Treatment with corticosteroids or other immunosuppressive drugs Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program. Participation in any other investigational trial simultaneously Planned surgery during the study period Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 4 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Haemophilus influenzae type b vaccine<br>* 3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine<br>|
| Active Comparator: 2<br> | Biological: Commercial Haemophilus influenzae type b vaccine<br>* 3 doses one month apart of Haemophilus influenzae type b vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated. |  | 90 days | 

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