Safety and Reactogenicity 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 reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children

Official Title
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A Phase I, Single-arm, Single-center Study to Investigate Safety and Reactogenicity of Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b in Healthy Children Aged 16 - 20 Months and Infants Aged 2 - 4 Months

Conditions
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Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: Haemophilus influenzae type b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants of either sex, aged 16 - 20 months / 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; written informed consent 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 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; infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already); 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) and/or 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; treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months); any vaccination administered within 2 weeks (14 days) before enrollment; 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: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Haemophilus influenzae type b<br>* 1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated. |  | 30 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 second 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