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

Novartis

Status and phase

Completed

Phase 1

Conditions

Haemophilus Influenzae Type b

Treatments

Biological: Haemophilus influenzae type b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00734565

M37P1

Details and patient eligibility

About

This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children

Enrollment

40 patients

Sex

All

Ages

2 to 20 months old

Volunteers

Accepts Healthy Volunteers

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