Status:
COMPLETED
Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Lead Sponsor:
Novartis Vaccines
Conditions:
Haemophilus Influenzae Type b
Eligibility:
All Genders
2-20 years
Phase:
PHASE1
Brief Summary
This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00734565
Start Date
July 1 2008
End Date
October 1 2008
Last Update
February 8 2012
Active Locations (1)
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1
Vaccination site
Shijiazhuang, China, 050800