A phase I study to investigate safety and reactogenicity of Vaxem Hib in healthy children aged 16 – 20 months and infants aged 2 - 4 months. - Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against HAEMOPHILUS INFLUENZAE TYPE b.

ovartis Vaccines and Diagnostics0 sites40 target enrollmentNovember 18, 2014

Overview

No summary available.

Registry

who.int

Start Date

November 18, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Vaccines and Diagnostics

•1\) Infants of either sex, aged 16 \- 20 months / 2 \- 4 months;
•2\) in good health as determined by:
•medical history
•physical examination
•clinical judgment of the investigator.
•3\) available for all visits scheduled in the study and able to comply with all study
•regulations;
•4\) written informed consent obtained, from at least one parent or legal guardian;
•Informed consent must be obtained for all the subjects before enrollment into the study
•Are the trial subjects under 18? yes

•1\) parent or legal guardian is unwilling or unable to give written informed consent to participate in study;
•2\) infants who presented a previous disease potentially related to Haemophilus influenzae type b;
•3\) infants who had household contact and/or intimate exposure in the previous 30mdays to an individual with ascertained Haemophilus influenzae type b disease;
•4\) infants who have received any other Haemophilus influenzae type b immunizationmdose before (for 16\-20 months old children who have received a booster vaccination already);
•5\) premature (before 37th week of gestation) or birth weight less than 2500 g;
•6\) history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
•7\) 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;
•8\) subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;
•9\) known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
•10\) subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder;